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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02186171
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis in Men Biological: Romosozumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
Actual Study Start Date : June 16, 2014
Actual Primary Completion Date : February 15, 2016
Actual Study Completion Date : April 20, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Romosozumab

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186171


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

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02186171    
Other Study ID Numbers: 20110174
2013-005551-32 ( EudraCT Number )
First Posted: July 10, 2014    Key Record Dates
Results First Posted: May 28, 2019
Last Update Posted: May 28, 2019
Last Verified: May 2019
Keywords provided by Amgen:
Osteoporosis in men
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases