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Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH)

Primary Purpose

Postmenopausal Women With Osteoporosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Romosozumab

Alendronate

Placebo to Romosozumab

Placebo to Alendronate

About this trial

This is an interventional treatment trial for Postmenopausal Women With Osteoporosis focused on measuring Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:

BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
- at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR
- at least 2 mild (SQ1) vertebral fractures OR
BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
- at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
- a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

Exclusion Criteria:

History of metabolic or bone disease (except osteoporosis)
Use of agents affecting bone metabolism
Vitamin D insufficiency
History of solid organ or bone marrow transplants
Hyper- or hypocalcemia
Hyper- or hypothyroidism
Hyper- or hypoparathyroidism
Possible signs of intolerance to alendronate

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Alendronate/Alendronate

Romosozumab/Alendronate

Arm Description

Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.

Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Outcomes

Primary Outcome Measures

Percentage of Participants With New Vertebral Fractures Through Month 24

All fracture assessments were performed by blinded central imaging readers. New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale: Grade 0 (Normal) = no fracture; Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.

Percentage of Participants With a Clinical Fracture at the Primary Analysis

All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.

Secondary Outcome Measures

Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis

A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.

Percentage of Participants With Any Fracture at the Primary Analysis

All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.

Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale: Grade 0 (Normal) = no fracture; Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.

Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis

Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.

Percentage of Participants With a Hip Fracture at the Primary Analysis

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader.

Percentage of Participants With a Clinical Fracture Through Month 24

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.

Percentage of Participants With a Nonvertebral Fracture Through Month 24

Percentage of Participants With a Hip Fracture Through Month 24

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Percentage of Participants With a Clinical Vertebral Fracture Through Month 24

A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.

Percentage of Participants With a Clinical Fracture Through Month 12

Percentage of Participants With New Vertebral Fractures Through Month 12

New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale: Grade 0 (Normal) = no fracture; Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. Incident vertebral fractures were confirmed by a second independent reader.

Percentage of Participants With Any Fracture Through Month 12

Percentage of Participants With a Nonvertebral Fracture Through Month 12

A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.

Percentage of Participants With a Hip Fracture Through Month 12

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Percentage of Participants With a Major Osteoporotic Fracture Through Month 12

Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.

Percentage of Participants With a Clinical Vertebral Fracture Through Month 12

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Full Information

NCT ID

NCT01631214

First Posted

May 24, 2012

Last Updated

November 4, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01631214

Brief Title

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Acronym

ARCH

Official Title

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

May 4, 2012 (Actual)

Primary Completion Date

February 27, 2017 (Actual)

Study Completion Date

June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

Detailed Description

In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained. The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Women With Osteoporosis

Keywords

Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4093 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alendronate/Alendronate

Arm Type

Active Comparator

Arm Description

Arm Title

Romosozumab/Alendronate

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Romosozumab

Other Intervention Name(s)

AMG 785, Evenity

Intervention Description

Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

Intervention Type

Drug

Intervention Name(s)

Alendronate

Other Intervention Name(s)

Fosamax

Intervention Description

Alendronate 70 mg tablet taken once a week

Intervention Type

Drug

Intervention Name(s)

Placebo to Romosozumab

Intervention Description

Administered by subcutaneous injection once a month during the double-blind treatment phase.

Intervention Type

Drug

Intervention Name(s)

Placebo to Alendronate

Intervention Description

Matching placebo tablet taken once a week during the double-blind treatment phase.

Primary Outcome Measure Information:

Title

Percentage of Participants With New Vertebral Fractures Through Month 24

Description

Time Frame

24 months

Title

Percentage of Participants With a Clinical Fracture at the Primary Analysis

Description

Time Frame

The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis

Description

Time Frame

Title

Percentage of Participants With Any Fracture at the Primary Analysis

Description

Time Frame

Title

Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24

Description

Time Frame

24 months

Title

Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis

Description

Time Frame

Title

Percentage of Participants With a Hip Fracture at the Primary Analysis

Description

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Time Frame

Title

Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24

Description

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader.

Time Frame

24 months

Title

Percentage of Participants With a Clinical Fracture Through Month 24

Description

Time Frame

24 months

Title

Percentage of Participants With a Nonvertebral Fracture Through Month 24

Description

Time Frame

24 months

Title

Percentage of Participants With a Hip Fracture Through Month 24

Description

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Time Frame

24 months

Title

Percentage of Participants With a Clinical Vertebral Fracture Through Month 24

Description

Time Frame

24 months

Title

Percentage of Participants With a Clinical Fracture Through Month 12

Description

Time Frame

12 months

Title

Percentage of Participants With New Vertebral Fractures Through Month 12

Description

Time Frame

12 months

Title

Percentage of Participants With Any Fracture Through Month 12

Description

Time Frame

12 months

Title

Percentage of Participants With a Nonvertebral Fracture Through Month 12

Description

Time Frame

12 months

Title

Percentage of Participants With a Hip Fracture Through Month 12

Description

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

Time Frame

12 months

Title

Percentage of Participants With a Major Osteoporotic Fracture Through Month 12

Description

Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.

Time Frame

12 months

Title

Percentage of Participants With a Clinical Vertebral Fracture Through Month 12

Description

Time Frame

12 months

Title

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 24

Title

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 24

Title

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 24

Title

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 12

Title

Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 12

Title

Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 12

Title

Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 36

Title

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 36

Title

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36

Description

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time Frame

Baseline and month 36

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria: BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER: at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR at least 2 mild (SQ1) vertebral fractures OR BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER: at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization. Exclusion Criteria: History of metabolic or bone disease (except osteoporosis) Use of agents affecting bone metabolism Vitamin D insufficiency History of solid organ or bone marrow transplants Hyper- or hypocalcemia Hyper- or hypothyroidism Hyper- or hypoparathyroidism Possible signs of intolerance to alendronate

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Research Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

Research Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Research Site

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

Research Site

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Research Site

City

South Lake Tahoe

State/Province

California

ZIP/Postal Code

96150

Country

United States

Facility Name

Research Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Research Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Research Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80227

Country

United States

Facility Name

Research Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33309

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Research Site

City

Stuart

State/Province

Florida

ZIP/Postal Code

34996

Country

United States

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Research Site

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Research Site

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Research Site

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Research Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Research Site

City

Las Cruces

State/Province

New Mexico

ZIP/Postal Code

88011

Country

United States

Facility Name

Research Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Research Site

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58503

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Research Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23233

Country

United States

Facility Name

Research Site

City

Port Angeles

State/Province

Washington

ZIP/Postal Code

98362

Country

United States

Facility Name

Research Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

Research Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1114

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1430CKE

Country

Argentina

Facility Name

Research Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600DHK

Country

Argentina

Facility Name

Research Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878DVB

Country

Argentina

Facility Name

Research Site

City

Cordoba

State/Province

Córdoba

ZIP/Postal Code

X5000BNB

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Research Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Research Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Research Site

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Research Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Research Site

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Research Site

City

Heidelberg West

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Research Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Research Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Research Site

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1060

Country

Austria

Facility Name

Research Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Research Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Research Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Liège

ZIP/Postal Code

4020

Country

Belgium

Facility Name

Research Site

City

Fortaleza

State/Province

Ceará

ZIP/Postal Code

60115-282

Country

Brazil

Facility Name

Research Site

City

Brasília

State/Province

Distrito Federal

ZIP/Postal Code

71625-009

Country

Brazil

Facility Name

Research Site

City

Vitória

State/Province

Espírito Santo

ZIP/Postal Code

29055-450

Country

Brazil

Facility Name

Research Site

City

Goiania

State/Province

Goiás

ZIP/Postal Code

74070-040

Country

Brazil

Facility Name

Research Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80030-110

Country

Brazil

Facility Name

Research Site

City

Recife

State/Province

Pernambuco

ZIP/Postal Code

52020-010

Country

Brazil

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

05437-010

Country

Brazil

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1202

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1421

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1504

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

Research Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Research Site

City

St. Johns

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

Research Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Research Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 1A1

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 2T2

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Research Site

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Research Site

City

Westmout

State/Province

Quebec

ZIP/Postal Code

H3Z 1E5

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8350595

Country

Chile

Facility Name

Research Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050021

Country

Colombia

Facility Name

Research Site

City

Barranquilla

State/Province

Atlántico

ZIP/Postal Code

08001000

Country

Colombia

Facility Name

Research Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

11001000

Country

Colombia

Facility Name

Research Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Research Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Research Site

City

Bogota

ZIP/Postal Code

11001000

Country

Colombia

Facility Name

Research Site

City

Bucaramanga

ZIP/Postal Code

68003

Country

Colombia

Facility Name

Research Site

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Research Site

City

Klatovy

ZIP/Postal Code

339 38

Country

Czechia

Facility Name

Research Site

City

Opava

ZIP/Postal Code

746 01

Country

Czechia

Facility Name

Research Site

City

Ostrava-Trebovice

ZIP/Postal Code

722 00

Country

Czechia

Facility Name

Research Site

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Research Site

City

Plzen

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Research Site

City

Praha 3

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Research Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Research Site

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Research Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Research Site

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Facility Name

Research Site

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Research Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Research Site

City

Koge

ZIP/Postal Code

4600

Country

Denmark

Facility Name

Research Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Research Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Research Site

City

Århus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Research Site

City

Santo Domingo

State/Province

Distrito Nacional

ZIP/Postal Code

10124

Country

Dominican Republic

Facility Name

Research Site

City

Santo Domingo

State/Province

Distrito Nacional

ZIP/Postal Code

10514

Country

Dominican Republic

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

51000

Country

Dominican Republic

Facility Name

Research Site

City

Santo Domingo

ZIP/Postal Code

10605

Country

Dominican Republic

Facility Name

Research Site

City

Tallinn

ZIP/Postal Code

10128

Country

Estonia

Facility Name

Research Site

City

Tartu

ZIP/Postal Code

50410

Country

Estonia

Facility Name

Research Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Research Site

City

Jyväskylä

ZIP/Postal Code

40100

Country

Finland

Facility Name

Research Site

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

Facility Name

Research Site

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Research Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Research Site

City

Cahors Cedex

ZIP/Postal Code

46005

Country

France

Facility Name

Research Site

City

Lille cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Research Site

City

Lyon Cédex 3

ZIP/Postal Code

69437

Country

France

Facility Name

Research Site

City

Orleans Cedex

ZIP/Postal Code

45067

Country

France

Facility Name

Research Site

City

Saint Priest en Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

Research Site

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Research Site

City

Vandoeuvre les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Research Site

City

Berlin (Hellersdorf)

ZIP/Postal Code

12627

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Research Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Research Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60528

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Research Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30167

Country

Germany

Facility Name

Research Site

City

Heinsberg

ZIP/Postal Code

52525

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Research Site

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Research Site

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Research Site

City

Würzburg

ZIP/Postal Code

97074

Country

Germany

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11525

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11526

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

14561

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

16673

Country

Greece

Facility Name

Research Site

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

56403

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Research Site

City

Antigua

State/Province

Sacatepéquez

ZIP/Postal Code

03001

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01001

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01007

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01009

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01012

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01014

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Research Site

City

Guatemala

ZIP/Postal Code

01052

Country

Guatemala

Facility Name

Research Site

City

Hong Kong

Country

Hong Kong

Facility Name

Research Site

City

New Territories

Country

Hong Kong

Facility Name

Research Site

City

Balatonfured

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Research Site

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1084

Country

Hungary

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Research Site

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Research Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Research Site

City

Kiskunhalas

ZIP/Postal Code

6400

Country

Hungary

Facility Name

Research Site

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Research Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Research Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Research Site

City

Cork

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Galway

Country

Ireland

Facility Name

Research Site

City

Bnei Brak

ZIP/Postal Code

51108

Country

Israel

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

71713

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91007

Country

Israel

Facility Name

Research Site

City

Tel Aviv

ZIP/Postal Code

61999

Country

Israel

Facility Name

Research Site

City

Arenzano GE

ZIP/Postal Code

16011

Country

Italy

Facility Name

Research Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Research Site

City

Catania

ZIP/Postal Code

95124

Country

Italy

Facility Name

Research Site

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Research Site

City

Milan

ZIP/Postal Code

20145

Country

Italy

Facility Name

Research Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Research Site

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Research Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Research Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Research Site

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Research Site

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

700-712

Country

Korea, Republic of

Facility Name

Research Site

City

Guri-si

ZIP/Postal Code

471-701

Country

Korea, Republic of

Facility Name

Research Site

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si, Gyeonggi-do

ZIP/Postal Code

443-380

Country

Korea, Republic of

Facility Name

Research Site

City

Liepaja

ZIP/Postal Code

3401

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

1011

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

1012

Country

Latvia

Facility Name

Research Site

City

Vilnius

ZIP/Postal Code

09310

Country

Lithuania

Facility Name

Research Site

City

Vilnius

ZIP/Postal Code

10323

Country

Lithuania

Facility Name

Research Site

City

Mexicali

State/Province

Baja California Norte

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Research Site

City

Mexicalli

State/Province

Baja California Norte

ZIP/Postal Code

21200

Country

Mexico

Facility Name

Research Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Research Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Research Site

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37000

Country

Mexico

Facility Name

Research Site

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37520

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

Queretaro

State/Province

Querétaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Research Site

City

Ciudad Obregon

State/Province

Sonora

ZIP/Postal Code

85000

Country

Mexico

Facility Name

Research Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Research Site

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Research Site

City

Christchurch

ZIP/Postal Code

8022

Country

New Zealand

Facility Name

Research Site

City

Grafton, Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

Research Site

City

Elverum

ZIP/Postal Code

2408

Country

Norway

Facility Name

Research Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Research Site

City

Oslo

ZIP/Postal Code

0050

Country

Norway

Facility Name

Research Site

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima11

Country

Peru

Facility Name

Research Site

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Research Site

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Research Site

City

Dabrowka Dopiewo

ZIP/Postal Code

62-069

Country

Poland

Facility Name

Research Site

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Research Site

City

Gdynia

ZIP/Postal Code

81-384

Country

Poland

Facility Name

Research Site

City

Gliwice

ZIP/Postal Code

44-100

Country

Poland

Facility Name

Research Site

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Research Site

City

Kielce

ZIP/Postal Code

25-317

Country

Poland

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

09-245

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

90-558

Country

Poland

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

60-356

Country

Poland

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

60-702

Country

Poland

Facility Name

Research Site

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

Research Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

53-224

Country

Poland

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

011172

Country

Romania

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

011863

Country

Romania

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

030463

Country

Romania

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

011863

Country

Romania

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

020125

Country

Romania

Facility Name

Research Site

City

Oradea

ZIP/Postal Code

410028

Country

Romania

Facility Name

Research Site

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Research Site

City

Arkhangelsk

ZIP/Postal Code

163001

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Research Site

City

Ivanovo

ZIP/Postal Code

153025

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

127299

Country

Russian Federation

Facility Name

Research Site

City

Nizhniy Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

199034

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Research Site

City

Banska Bystrica

ZIP/Postal Code

974 01

Country

Slovakia

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Research Site

City

Kosice-Saca

ZIP/Postal Code

040 15

Country

Slovakia

Facility Name

Research Site

City

Lucenec

ZIP/Postal Code

984 01

Country

Slovakia

Facility Name

Research Site

City

Piestany

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

Research Site

City

Trencin

ZIP/Postal Code

911 01

Country

Slovakia

Facility Name

Research Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Research Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Research Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Research Site

City

Parow

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Research Site

City

Somerset West

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Research Site

City

Tygerberg

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Research Site

City

Granada

State/Province

Andalucía

ZIP/Postal Code

18012

Country

Spain

Facility Name

Research Site

City

Sevilla

State/Province

Andalucía

ZIP/Postal Code

41009

Country

Spain

Facility Name

Research Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Research Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08003

Country

Spain

Facility Name

Research Site

City

Sant Joan Despi

State/Province

Cataluña

ZIP/Postal Code

08970

Country

Spain

Facility Name

Research Site

City

A Coruña

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Research Site

City

Linköping

ZIP/Postal Code

581 85

Country

Sweden

Facility Name

Research Site

City

Mölndal

ZIP/Postal Code

431 80

Country

Sweden

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Research Site

City

Umeå

ZIP/Postal Code

907 36

Country

Sweden

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34890

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Research Site

City

Birmingham

ZIP/Postal Code

B15 2SQ

Country

United Kingdom

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

Cardiff

ZIP/Postal Code

CF14 5GJ

Country

United Kingdom

Facility Name

Research Site

City

Chorley

ZIP/Postal Code

PR7 7NA

Country

United Kingdom

Facility Name

Research Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Research Site

City

Glasgow

ZIP/Postal Code

G20 0SP

Country

United Kingdom

Facility Name

Research Site

City

Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M15 6SX

Country

United Kingdom

Facility Name

Research Site

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Research Site

City

Norwich

ZIP/Postal Code

NR4 7TJ

Country

United Kingdom

Facility Name

Research Site

City

Reading

ZIP/Postal Code

RG2 0FT

Country

United Kingdom

Facility Name

Research Site

City

Sheffield

ZIP/Postal Code

S5 7AU

Country

United Kingdom

Facility Name

Research Site

City

Sidcup

ZIP/Postal Code

DA14 6LT

Country

United Kingdom

Facility Name

Research Site

City

Staffordshire

ZIP/Postal Code

WS11 5XY

Country

United Kingdom

Facility Name

Research Site

City

Warwick

ZIP/Postal Code

CV34 5BW

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28892457

Citation

Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.

Results Reference

background

PubMed Identifier

34190361

Citation

Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.

Results Reference

derived

PubMed Identifier

32445228

Citation

Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

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Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH)

Postmenopausal Women With Osteoporosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial