A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
BRIDGE
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
2 other identifiers
interventional
245
10 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2014
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2014
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2016
CompletedResults Posted
Study results publicly available
May 28, 2019
CompletedMay 28, 2019
May 1, 2019
1.7 years
June 23, 2014
May 3, 2019
May 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and month 12
Secondary Outcomes (5)
Percent Change From Baseline in BMD at the Total Hip at Month 12
Baseline and month 12
Percent Change From Baseline in BMD at the Femoral Neck at Month 12
Baseline and month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Baseline and month 6
Percent Change From Baseline in BMD at the Total Hip at Month 6
Baseline and month 6
Percent Change From Baseline in BMD at the Femoral Neck at Month 6
Baseline and month 6
Study Arms (2)
Romosozumab
EXPERIMENTALParticipants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Placebo
PLACEBO COMPARATORParticipants received placebo subcutaneous injections once a month for 12 months.
Interventions
Administered by subcutaneous injection once a month.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (34)
Research Site
Lakewood, Colorado, 80227, United States
Research Site
Bethesda, Maryland, 20817, United States
Research Site
Albuquerque, New Mexico, 87106, United States
Research Site
Genk, 3600, Belgium
Research Site
Ghent, 9000, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Liège, 4020, Belgium
Research Site
Medellín, Antioquia, 050021, Colombia
Research Site
Bogota, Cundinamarca, 11001000, Colombia
Research Site
Ostrava-Trebovice, 722 00, Czechia
Research Site
Pilsen, 305 99, Czechia
Research Site
Praha 11 - Chodov, 148 00, Czechia
Research Site
Aalborg, 9000, Denmark
Research Site
Ballerup Municipality, 2750, Denmark
Research Site
Mizunami-shi, Gifu, 509-6134, Japan
Research Site
Yokohama, Kanagawa, 223-0062, Japan
Research Site
Bungoono-shi, Oita Prefecture, 879-7125, Japan
Research Site
Takatsuki-shi, Osaka, 569-1123, Japan
Research Site
Hachioji-shi, Tokyo, 192-0046, Japan
Research Site
Shinagawa-ku, Tokyo, 140-0011, Japan
Research Site
Toshima-ku, Tokyo, 171-0033, Japan
Research Site
Mexicali, Baja California Norte, 21100, Mexico
Research Site
Monterrey, Nuevo León, 64460, Mexico
Research Site
Culiacán, Sinaloa, 80000, Mexico
Research Site
Lodz, 90-558, Poland
Research Site
Świdnik, 21-040, Poland
Research Site
Warsaw, 01-192, Poland
Research Site
Wroclaw, 50-088, Poland
Research Site
Moscow, 101990, Russia
Research Site
Saint Petersburg, 190103, Russia
Research Site
Yaroslavl, 150003, Russia
Research Site
Bern, 3010, Switzerland
Research Site
Zurich, 8063, Switzerland
Research Site
Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 29931216BACKGROUND
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
July 10, 2014
Study Start
June 16, 2014
Primary Completion
February 15, 2016
Study Completion
April 20, 2016
Last Updated
May 28, 2019
Results First Posted
May 28, 2019
Record last verified: 2019-05