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Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)

Primary Purpose

Postmenopausal Osteoporosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Romosozumab

Placebo

Denosumab

About this trial

This is an interventional treatment trial for Postmenopausal 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 with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Exclusion Criteria:

BMD T-score of ≤ -3.50 at the total hip or femoral neck
History of hip fracture
Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
Use of agents affecting bone metabolism
History of metabolic or bone disease (except osteoporosis)
Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
Current hyper- or hypocalcemia
Current, uncontrolled hyper- or hypothyroidism
Current, uncontrolled hyper- or hypoparathyroidism

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Romosozumab

Placebo

Arm Description

Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

Outcomes

Primary Outcome Measures

Percentage of Participants With New Vertebral Fracture 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. The Genant semiquantitative scoring method was 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.

Percentage of Participants With New Vertebral Fracture Through Month 24

Secondary Outcome Measures

Percentage of Participants With a Clinical Fracture Through Month 12

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 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 Nonvertebral Fracture Through Month 24

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 as 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 Clinical Fracture Through Month 24

Percentage of Participants With a Major Nonvertebral Fracture Through Month 12

A major nonvertebral fracture was 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 Major Nonvertebral Fracture Through Month 24

Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12

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.

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.

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 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 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 Major Osteoporotic Fracture Through Month 24

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 Multiple New or Worsening Vertebral Fractures Through Month 12

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. 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.

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

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 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 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 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 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 Femoral Neck 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.

Full Information

NCT ID

NCT01575834

First Posted

April 4, 2012

Last Updated

December 8, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01575834

Brief Title

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Acronym

FRAME

Official Title

A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

March 15, 2012 (Actual)

Primary Completion Date

December 14, 2015 (Actual)

Study Completion Date

December 28, 2016 (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 with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

6. Conditions and Keywords

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

Postmenopausal 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

7180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Romosozumab

Arm Type

Experimental

Arm Description

Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

Intervention Type

Drug

Intervention Name(s)

Romosozumab

Other Intervention Name(s)

AMG 785, EVENITY™

Intervention Description

Administered by subcutaneous injection once a month (QM)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered by subcutaneous injection once a month (QM)

Intervention Type

Drug

Intervention Name(s)

Denosumab

Other Intervention Name(s)

Prolia®

Intervention Description

Administered by subcutaneous injection once every 6 months (Q6M)

Primary Outcome Measure Information:

Title

Percentage of Participants With New Vertebral Fracture Through Month 12

Description

Time Frame

12 Months

Title

Percentage of Participants With New Vertebral Fracture Through Month 24

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Clinical 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 Nonvertebral Fracture Through Month 24

Description

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 as 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.

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 Major Nonvertebral Fracture Through Month 12

Description

Time Frame

12 Months

Title

Percentage of Participants With a Major Nonvertebral Fracture Through Month 24

Description

Time Frame

24 Months

Title

Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12

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.

Time Frame

12 Months

Title

Percentage of Participants With a New or Worsening Vertebral Fracture 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.

Time Frame

24 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 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 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 Major Osteoporotic Fracture Through Month 24

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

24 Months

Title

Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12

Description

Time Frame

12 Months

Title

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

Description

Time Frame

24 Months

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 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 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 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 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 Femoral Neck 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

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 with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50) Exclusion Criteria: BMD T-score of ≤ -3.50 at the total hip or femoral neck History of hip fracture Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays Use of agents affecting bone metabolism History of metabolic or bone disease (except osteoporosis) Vitamin D insufficiency (vitamin D repletion and rescreening is permitted) Current hyper- or hypocalcemia Current, uncontrolled hyper- or hypothyroidism Current, uncontrolled hyper- or hypoparathyroidism

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

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Research Site

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

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

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Research Site

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

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

Leesburg

State/Province

Florida

ZIP/Postal Code

34748

Country

United States

Facility Name

Research Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Research Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Research Site

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Research Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

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

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Research Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Research Site

City

Mayfield

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Research Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Research Site

City

Denton

State/Province

Texas

ZIP/Postal Code

76210-8625

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

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

C1012AAR

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1015ABO

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

Cordoba

State/Province

Córdoba

ZIP/Postal Code

X5000BNB

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1425ACG

Country

Argentina

Facility Name

Research Site

City

Maroubra

State/Province

New South Wales

ZIP/Postal Code

2035

Country

Australia

Facility Name

Research Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Research Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Research Site

City

Keswick

State/Province

South Australia

ZIP/Postal Code

5035

Country

Australia

Facility Name

Research Site

City

Footscray

State/Province

Victoria

ZIP/Postal Code

3011

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

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

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

Ghent

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

Lommel

ZIP/Postal Code

3920

Country

Belgium

Facility Name

Research Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Research Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80030-110

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

04063-001

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

05403-000

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

05437-010

Country

Brazil

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

Research Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Research Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6M 1M1

Country

Canada

Facility Name

Research Site

City

Lachine

State/Province

Quebec

ZIP/Postal Code

H8S 2E4

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

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

ZIP/Postal Code

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

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Research Site

City

Ceske Budejovice

ZIP/Postal Code

370 87

Country

Czechia

Facility Name

Research Site

City

Havlickuv Brod

ZIP/Postal Code

580 22

Country

Czechia

Facility Name

Research Site

City

Klatovy

ZIP/Postal Code

339 38

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 11 - Chodov

ZIP/Postal Code

148 00

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 50

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

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

Santo Domingo

ZIP/Postal Code

10605

Country

Dominican Republic

Facility Name

Research Site

City

Pärnu

ZIP/Postal Code

80013

Country

Estonia

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

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

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Research Site

City

Dresden

ZIP/Postal Code

01067

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

60313

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60528

Country

Germany

Facility Name

Research Site

City

Görlitz

ZIP/Postal Code

02826

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

39120

Country

Germany

Facility Name

Research Site

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Research Site

City

Schkeuditz

ZIP/Postal Code

04435

Country

Germany

Facility Name

Research Site

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1027

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

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Research Site

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Research Site

City

Heviz

ZIP/Postal Code

8380

Country

Hungary

Facility Name

Research Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Research Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Research Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 054

Country

India

Facility Name

Research Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 012

Country

India

Facility Name

Research Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 005

Country

India

Facility Name

Research Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302 019

Country

India

Facility Name

Research Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 020

Country

India

Facility Name

Research Site

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632 004

Country

India

Facility Name

Research Site

City

Anjyo-shi

State/Province

Aichi

ZIP/Postal Code

446-0063

Country

Japan

Facility Name

Research Site

City

Urayasu-shi

State/Province

Chiba

ZIP/Postal Code

279-0004

Country

Japan

Facility Name

Research Site

City

Fukui-shi

State/Province

Fukui

ZIP/Postal Code

910-0005

Country

Japan

Facility Name

Research Site

City

Fukui-shi

State/Province

Fukui

ZIP/Postal Code

910-0067

Country

Japan

Facility Name

Research Site

City

Fukui-shi

State/Province

Fukui

ZIP/Postal Code

918-8057

Country

Japan

Facility Name

Research Site

City

Fukui-shi

State/Province

Fukui

ZIP/Postal Code

918-8236

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

814-0111

Country

Japan

Facility Name

Research Site

City

Fukutsu-shi

State/Province

Fukuoka

ZIP/Postal Code

811-3217

Country

Japan

Facility Name

Research Site

City

Kitakyushu-shi

State/Province

Fukuoka

ZIP/Postal Code

806-0026

Country

Japan

Facility Name

Research Site

City

Kurume-shi

State/Province

Fukuoka

ZIP/Postal Code

830-0053

Country

Japan

Facility Name

Research Site

City

Kurume-shi

State/Province

Fukuoka

ZIP/Postal Code

839-0832

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

State/Province

Hiroshima

ZIP/Postal Code

733-0032

Country

Japan

Facility Name

Research Site

City

Chitose-shi

State/Province

Hokkaido

ZIP/Postal Code

066-0062

Country

Japan

Facility Name

Research Site

City

Ishikari-shi

State/Province

Hokkaido

ZIP/Postal Code

061-3203

Country

Japan

Facility Name

Research Site

City

Sunagawa-shi

State/Province

Hokkaido

ZIP/Postal Code

073-0196

Country

Japan

Facility Name

Research Site

City

Akashi-shi

State/Province

Hyogo

ZIP/Postal Code

674-0051

Country

Japan

Facility Name

Research Site

City

Kako-gun

State/Province

Hyogo

ZIP/Postal Code

675-1115

Country

Japan

Facility Name

Research Site

City

Toride-shi

State/Province

Ibaraki

ZIP/Postal Code

302-0022

Country

Japan

Facility Name

Research Site

City

Morioka-shi

State/Province

Iwate

ZIP/Postal Code

020-0015

Country

Japan

Facility Name

Research Site

City

Takamatsu-shi

State/Province

Kagawa

ZIP/Postal Code

760-8538

Country

Japan

Facility Name

Research Site

City

Kirishima-shi

State/Province

Kagoshima

ZIP/Postal Code

899-5102

Country

Japan

Facility Name

Research Site

City

Minamikyusyu-shi

State/Province

Kagoshima

ZIP/Postal Code

897-0215

Country

Japan

Facility Name

Research Site

City

Atugi-shi

State/Province

Kanagawa

ZIP/Postal Code

243-0122

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

State/Province

Kanagawa

ZIP/Postal Code

252-5225

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

223-0059

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

223-0062

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

227-0064

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

231-0023

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

231-0861

Country

Japan

Facility Name

Research Site

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

860-0066

Country

Japan

Facility Name

Research Site

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

981-3213

Country

Japan

Facility Name

Research Site

City

Chiisagata-gun

State/Province

Nagano

ZIP/Postal Code

386-0603

Country

Japan

Facility Name

Research Site

City

Matsumoto-shi

State/Province

Nagano

ZIP/Postal Code

390-1401

Country

Japan

Facility Name

Research Site

City

Matsumoto-shi

State/Province

Nagano

ZIP/Postal Code

390-8601

Country

Japan

Facility Name

Research Site

City

Ueda-shi

State/Province

Nagano

ZIP/Postal Code

386-0151

Country

Japan

Facility Name

Research Site

City

Ueda-shi

State/Province

Nagano

ZIP/Postal Code

386-0405

Country

Japan

Facility Name

Research Site

City

Bungoono-shi

State/Province

Oita

ZIP/Postal Code

879-7125

Country

Japan

Facility Name

Research Site

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

559-0011

Country

Japan

Facility Name

Research Site

City

Takatsuki-shi

State/Province

Osaka

ZIP/Postal Code

569-1123

Country

Japan

Facility Name

Research Site

City

Saga-shi

State/Province

Saga

ZIP/Postal Code

840-0027

Country

Japan

Facility Name

Research Site

City

Fujimi-shi

State/Province

Saitama

ZIP/Postal Code

354-0021

Country

Japan

Facility Name

Research Site

City

Matsue-shi

State/Province

Shimane

ZIP/Postal Code

699-0293

Country

Japan

Facility Name

Research Site

City

Fujinomiya-shi

State/Province

Shizuoka

ZIP/Postal Code

418-0026

Country

Japan

Facility Name

Research Site

City

Kikugawa-shi

State/Province

Shizuoka

ZIP/Postal Code

439-0012

Country

Japan

Facility Name

Research Site

City

Tokushima-Shi

State/Province

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Research Site

City

Hachioji-shi

State/Province

Tokyo

ZIP/Postal Code

192-0046

Country

Japan

Facility Name

Research Site

City

Kiyose-shi

State/Province

Tokyo

ZIP/Postal Code

204-0021

Country

Japan

Facility Name

Research Site

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

108-0075

Country

Japan

Facility Name

Research Site

City

Ota-ku

State/Province

Tokyo

ZIP/Postal Code

143-0015

Country

Japan

Facility Name

Research Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

157-0073

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

140-0001

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

140-0014

Country

Japan

Facility Name

Research Site

City

Suginami-ku

State/Province

Tokyo

ZIP/Postal Code

166-0001

Country

Japan

Facility Name

Research Site

City

Suginami-ku

State/Province

Tokyo

ZIP/Postal Code

166-0003

Country

Japan

Facility Name

Research Site

City

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

171-0033

Country

Japan

Facility Name

Research Site

City

Kofu-shi

State/Province

Yamanashi

ZIP/Postal Code

400-0831

Country

Japan

Facility Name

Research Site

City

Liepaja

ZIP/Postal Code

3401

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

1012

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

1038

Country

Latvia

Facility Name

Research Site

City

Kaunas

ZIP/Postal Code

49287

Country

Lithuania

Facility Name

Research Site

City

Kaunas

ZIP/Postal Code

49456

Country

Lithuania

Facility Name

Research Site

City

Klaipeda

ZIP/Postal Code

94231

Country

Lithuania

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

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

Ciudad Obregon

State/Province

Sonora

ZIP/Postal Code

85000

Country

Mexico

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

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

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

90-368

Country

Poland

Facility Name

Research Site

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-341

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

011172

Country

Romania

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

020125

Country

Romania

Facility Name

Research Site

City

Timisoara

ZIP/Postal Code

300736

Country

Romania

Facility Name

Research Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08041

Country

Spain

Facility Name

Research Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Research Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Research Site

City

Fribourg

ZIP/Postal Code

1708

Country

Switzerland

Facility Name

Research Site

City

Genève 14

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Research Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Research Site

City

Zurich

ZIP/Postal Code

8063

Country

Switzerland

Facility Name

Research Site

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Research Site

City

Chorley

ZIP/Postal Code

PR7 7NA

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

London

ZIP/Postal Code

DA14 6LT

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

Reading

ZIP/Postal Code

RG2 0TF

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27641143

Citation

Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.

Results Reference

background

PubMed Identifier

29573473

Citation

Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17.

Results Reference

background

PubMed Identifier

31233639

Citation

Chavassieux P, Chapurlat R, Portero-Muzy N, Roux JP, Garcia P, Brown JP, Libanati C, Boyce RW, Wang A, Grauer A. Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment. J Bone Miner Res. 2019 Sep;34(9):1597-1608. doi: 10.1002/jbmr.3735. Epub 2019 Jun 24.

Results Reference

background

PubMed Identifier

29750828

Citation

Cosman F, Crittenden DB, Ferrari S, Lewiecki EM, Jaller-Raad J, Zerbini C, Milmont CE, Meisner PD, Libanati C, Grauer A. Romosozumab FRAME Study: A Post Hoc Analysis of the Role of Regional Background Fracture Risk on Nonvertebral Fracture Outcome. J Bone Miner Res. 2018 Aug;33(8):1407-1416. doi: 10.1002/jbmr.3439. Epub 2018 May 11.

Results Reference

background

PubMed Identifier

30508316

Citation

Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3.

Results Reference

background

PubMed Identifier

31168657

Citation

Miyauchi A, Dinavahi RV, Crittenden DB, Yang W, Maddox JC, Hamaya E, Nakamura Y, Libanati C, Grauer A, Shimauchi J. Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension. Arch Osteoporos. 2019 Jun 5;14(1):59. doi: 10.1007/s11657-019-0608-z.

Results Reference

background

PubMed Identifier

33057807

Citation

Miyauchi A, Hamaya E, Yang W, Nishi K, Libanati C, Tolman C, Shimauchi J. Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial. J Bone Miner Metab. 2021 Mar;39(2):278-288. doi: 10.1007/s00774-020-01147-5. Epub 2020 Oct 15.

Results Reference

background

PubMed Identifier

33537844

Citation

McCloskey EV, Johansson H, Harvey NC, Lorentzon M, Shi Y, Kanis JA. Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study. Osteoporos Int. 2021 Aug;32(8):1601-1608. doi: 10.1007/s00198-020-05815-0. Epub 2021 Feb 3.

Results Reference

background

PubMed Identifier

34633116

Citation

Eriksen EF, Chapurlat R, Boyce RW, Shi Y, Brown JP, Horlait S, Betah D, Libanati C, Chavassieux P. Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial. J Bone Miner Res. 2022 Jan;37(1):36-40. doi: 10.1002/jbmr.4457. Epub 2021 Nov 19.

Results Reference

background

PubMed Identifier

35466448

Citation

Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.

Results Reference

background

PubMed Identifier

31707465

Citation

Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9. Erratum In: J Bone Miner Metab. 2020 Mar 20;:

Results Reference

background

PubMed Identifier

35639174

Citation

Miyauchi A, Hamaya E, Nishi K, Tolman C, Shimauchi J. Efficacy and safety of romosozumab among Japanese postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease. J Bone Miner Metab. 2022 Jul;40(4):677-687. doi: 10.1007/s00774-022-01332-8. Epub 2022 May 31.

Results Reference

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Links:

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Learn more about this trial

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

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Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)

Postmenopausal 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