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

May 3, 2019 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4020
        • Research Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050021
        • Research Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 11001000
        • Research Site
  • Czechia
      • Ostrava-Trebovice, Czechia, 722 00
        • Research Site
      • Plzen, Czechia, 305 99
        • Research Site
      • Praha 11 - Chodov, Czechia, 148 00
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
  • Japan
    • Gifu
      • Mizunami-shi, Gifu, Japan, 509-6134
        • Research Site
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan, 223-0062
        • Research Site
    • Oita
      • Bungoono-shi, Oita, Japan, 879-7125
        • Research Site
    • Osaka
      • Takatsuki-shi, Osaka, Japan, 569-1123
        • Research Site
    • Tokyo
      • Hachioji-shi, Tokyo, Japan, 192-0046
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 140-0011
        • Research Site
      • Toshima-ku, Tokyo, Japan, 171-0033
        • Research Site
  • Mexico
    • Baja California Norte
      • Mexicali, Baja California Norte, Mexico, 21100
        • Research Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Research Site
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80000
        • Research Site
  • Poland
      • Lodz, Poland, 90-558
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
      • Wroclaw, Poland, 50-088
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 101990
        • Research Site
      • Saint-Petersburg, Russian Federation, 190103
        • Research Site
      • Yaroslavl, Russian Federation, 150003
        • Research Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Research Site
      • Zurich, Switzerland, 8063
        • Research Site
      • Zurich, Switzerland, 8091
        • Research Site
  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Biological: Romosozumab
Administered by subcutaneous injection once a month.
Other Names:
  • AMG 785
  • EVENITY™
Placebo Comparator: Placebo
Participants received placebo subcutaneous injections once a month for 12 months.
Drug: Placebo
Administered by subcutaneous injection once a month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
Time Frame: Baseline and 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.
Baseline and month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in BMD at the Total Hip at Month 12
Time Frame: Baseline and month 12
Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline and month 12
Percent Change From Baseline in BMD at the Femoral Neck at Month 12
Time Frame: Baseline and 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.
Baseline and month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Time Frame: Baseline and 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.
Baseline and month 6
Percent Change From Baseline in BMD at the Total Hip at Month 6
Time Frame: Baseline and month 6
Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline and month 6
Percent Change From Baseline in BMD at the Femoral Neck at Month 6
Time Frame: Baseline and month 6
Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2014

Primary Completion (Actual)

February 15, 2016

Study Completion (Actual)

April 20, 2016

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110174
  • 2013-005551-32 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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