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A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE)

Primary Purpose

Osteoporosis in Men

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Romosozumab

Placebo

About this trial

This is an interventional treatment trial for Osteoporosis in Men focused on measuring Osteoporosis in men

Eligibility Criteria

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

Inclusion Criteria:

Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.

Exclusion Criteria:

A BMD T score ≤ -3.50 at the hip,
History of hip fracture
Severe metabolic bone diseases
Significant laboratory abnormalities
Recent treatment with agents affecting bone metabolism

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Romosozumab

Placebo

Arm Description

Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Participants received placebo subcutaneous injections once a month for 12 months.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12

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

Secondary Outcome Measures

Percent Change From Baseline in BMD at the Total Hip at Month 12

Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Percent Change From Baseline in BMD at the Femoral Neck at Month 12

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

Percent Change From Baseline in Lumbar Spine BMD at Month 6

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

Percent Change From Baseline in BMD at the Total Hip at Month 6

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

Percent Change From Baseline in BMD at the Femoral Neck at Month 6

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

Full Information

NCT ID

NCT02186171

First Posted

June 23, 2014

Last Updated

May 3, 2019

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02186171

Brief Title

A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

Acronym

BRIDGE

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

June 16, 2014 (Actual)

Primary Completion Date

February 15, 2016 (Actual)

Study Completion Date

April 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.

6. Conditions and Keywords

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

Osteoporosis in Men

Keywords

Osteoporosis in men

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

245 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Romosozumab

Arm Type

Experimental

Arm Description

Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo subcutaneous injections once a month for 12 months.

Intervention Type

Biological

Intervention Name(s)

Romosozumab

Other Intervention Name(s)

AMG 785, EVENITY™

Intervention Description

Administered by subcutaneous injection once a month.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered by subcutaneous injection once a month.

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12

Description

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

Time Frame

Baseline and month 12

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in BMD at the Total Hip at Month 12

Description

Total hip bone mineral density was measured by dual 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 BMD at the Femoral Neck at Month 12

Description

Femoral neck bone mineral density (BMD) was measured by dual 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 Lumbar Spine BMD at Month 6

Description

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

Time Frame

Baseline and month 6

Title

Percent Change From Baseline in BMD at the Total Hip at Month 6

Description

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

Time Frame

Baseline and month 6

Title

Percent Change From Baseline in BMD at the Femoral Neck at Month 6

Description

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

Time Frame

Baseline and month 6

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture. Exclusion Criteria: A BMD T score ≤ -3.50 at the hip, History of hip fracture Severe metabolic bone diseases Significant laboratory abnormalities Recent treatment with agents affecting bone metabolism

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

Lakewood

State/Province

Colorado

ZIP/Postal Code

80227

Country

United States

Facility Name

Research Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

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

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

Medellin

State/Province

Antioquia

ZIP/Postal Code

050021

Country

Colombia

Facility Name

Research Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

11001000

Country

Colombia

Facility Name

Research Site

City

Ostrava-Trebovice

ZIP/Postal Code

722 00

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

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Research Site

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Facility Name

Research Site

City

Mizunami-shi

State/Province

Gifu

ZIP/Postal Code

509-6134

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

223-0062

Country

Japan

Facility Name

Research Site

City

Bungoono-shi

State/Province

Oita

ZIP/Postal Code

879-7125

Country

Japan

Facility Name

Research Site

City

Takatsuki-shi

State/Province

Osaka

ZIP/Postal Code

569-1123

Country

Japan

Facility Name

Research Site

City

Hachioji-shi

State/Province

Tokyo

ZIP/Postal Code

192-0046

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

140-0011

Country

Japan

Facility Name

Research Site

City

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

171-0033

Country

Japan

Facility Name

Research Site

City

Mexicali

State/Province

Baja California Norte

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

90-558

Country

Poland

Facility Name

Research Site

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Research Site

City

Bern

ZIP/Postal Code

3010

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

29931216

Citation

Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

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A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE)

Osteoporosis in Men

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