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Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

Primary Purpose

Osteoporosis, Postmenopausal, Back Pain, Spinal Fracture

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

teriparatide

risedronate

placebo

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal women 45 years or older. No period for at least two years. History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator). Minimum of one moderate spinal bone fracture. Beginning pain level of at least four on an eleven point scale. Bone Mineral Density (BMD) must meet criteria Able to read, understand, and administer self-questionnaires. Be willing and able to use a pen-injector to deliver the medication. Exclusion Criteria: Are at increased risk for osteosarcoma. Have an active or suspected diseases that affects bone metabolism other than osteoporosis. Participants that already know that they will require procedures to repair their spinal bone fractures. Abnormal values of certain lab tests. Anything that would make it difficult to determine if the back pain was due to the fracture. Poor medical or psychiatric condition. Alcohol or drug abuse within a year of the study start. Certain malignant neoplasms in the 5 years prior to enrollment. Active liver disease or clinical jaundice. Significantly impaired renal function. History of nephrolithiasis or urolithiasis within 2 years prior to enrollment. Known contraindication or intolerance to risedronate and/or teriparatide therapy. Treatment with oral strontium or certain therapeutic doses of fluoride.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teriparatide

Risedronate

Arm Description

Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo

Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Outcomes

Primary Outcome Measures

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.

Secondary Outcome Measures

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months

Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months

Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.

Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).

Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.

Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.

Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.

Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Number of Participants With Adverse Events (Safety) During 12 Months

Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.

Number of Participants With Adverse Events (Safety) During 18 Months

Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months

Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.

Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.

Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Full Information

NCT ID

NCT00343252

First Posted

June 20, 2006

Last Updated

May 20, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00343252

Brief Title

Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

Official Title

The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

6. Conditions and Keywords

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

Osteoporosis, Postmenopausal, Back Pain, Spinal Fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

712 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriparatide

Arm Type

Experimental

Arm Description

Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo

Arm Title

Risedronate

Arm Type

Active Comparator

Arm Description

Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Intervention Type

Drug

Intervention Name(s)

teriparatide

Other Intervention Name(s)

LY333334, Forteo, Forsteo

Intervention Description

20 ug/day, subcutaneous, 18 months

Intervention Type

Drug

Intervention Name(s)

risedronate

Other Intervention Name(s)

Actonel

Intervention Description

35 mg/once weekly, oral, 18 months

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

LY333334, Forteo, Forsteo

Intervention Description

once weekly, oral, 18 months

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

Actonel

Intervention Description

daily, subcutaneous, 18 months

Primary Outcome Measure Information:

Title

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint

Description

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint

Description

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.

Time Frame

12 Months

Title

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint

Description

Time Frame

6 Months

Title

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint

Description

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.

Time Frame

12 Months

Title

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months

Description

Time Frame

Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

Title

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months

Description

Time Frame

Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

Title

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months

Description

Time Frame

Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

Title

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months

Description

Time Frame

Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

Title

Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.

Description

Time Frame

Baseline, 3 Months

Title

Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.

Description

Time Frame

Baseline, 6 Months

Title

Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.

Description

Time Frame

Baseline, 12 Months

Title

Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Description

Time Frame

Baseline, 6 Months

Title

Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Description

Time Frame

Baseline, 12 Months

Title

Number of Participants With Adverse Events (Safety) During 12 Months

Description

Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.

Time Frame

Baseline through 12 Months

Title

Number of Participants With Adverse Events (Safety) During 18 Months

Description

Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.

Time Frame

Baseline through 18 Months

Title

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint

Description

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.

Time Frame

18 Months

Title

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint

Description

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.

Time Frame

18 Months

Title

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months

Description

Time Frame

Baseline through 18 Months

Title

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months

Description

Time Frame

Baseline through 18 Months

Title

Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.

Description

Time Frame

Baseline, 18 Months

Title

Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Description

Time Frame

Baseline, 18 Months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36111

Country

United States

Facility Name

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

City

Morton Grove

State/Province

Illinois

ZIP/Postal Code

60053

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Urbandale

State/Province

Iowa

ZIP/Postal Code

50322

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98144

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

City

Beckley

State/Province

West Virginia

ZIP/Postal Code

25801

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1117ABH

Country

Argentina

Facility Name

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

City

Randwick, Sydney

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

City

Keswick

State/Province

South Australia

ZIP/Postal Code

5035

Country

Australia

Facility Name

City

Malvern East

ZIP/Postal Code

3145

Country

Australia

Facility Name

City

Brussels

ZIP/Postal Code

1180

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Gozee

ZIP/Postal Code

6534

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Tienen

ZIP/Postal Code

3300

Country

Belgium

Facility Name

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

City

Campinas

ZIP/Postal Code

13073-350

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

01246-903

Country

Brazil

Facility Name

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3X8

Country

Canada

Facility Name

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

City

Amiens

ZIP/Postal Code

80084

Country

France

Facility Name

City

Orleans

ZIP/Postal Code

45000

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75679

Country

France

Facility Name

City

Poitiers

ZIP/Postal Code

86000

Country

France

Facility Name

City

Braunfels

ZIP/Postal Code

35619

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

60528

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

City

Heidelberg

ZIP/Postal Code

D-69120

Country

Germany

Facility Name

City

Heinsberg

ZIP/Postal Code

52525

Country

Germany

Facility Name

City

Leipzig

ZIP/Postal Code

04207

Country

Germany

Facility Name

City

Marburg

ZIP/Postal Code

35033

Country

Germany

Facility Name

City

München

ZIP/Postal Code

80335

Country

Germany

Facility Name

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

City

Treviglio

ZIP/Postal Code

24047

Country

Italy

Facility Name

City

Valeggio Sul Mincio

ZIP/Postal Code

37067

Country

Italy

Facility Name

City

Leon

ZIP/Postal Code

37000

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64461

Country

Mexico

Facility Name

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

City

Malmo

ZIP/Postal Code

21120

Country

Sweden

Facility Name

City

Solna

ZIP/Postal Code

17176

Country

Sweden

Facility Name

City

Umeå

ZIP/Postal Code

90185

Country

Sweden

Facility Name

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

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