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Trial record 1 of 1 for:    NCT02186171
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A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE)

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ClinicalTrials.gov Identifier: NCT02186171
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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

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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


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.




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.



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

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


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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02186171     History of Changes
Other Study ID Numbers: 20110174
2013-005551-32 ( EudraCT Number )
First Posted: July 10, 2014    Key Record Dates
Results First Posted: May 27, 2019
Last Update Posted: May 27, 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