Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 23, 2014
First Posted Date  ICMJE July 10, 2014
Results First Submitted Date  ICMJE May 3, 2019
Results First Posted Date  ICMJE May 28, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE June 16, 2014
Actual Primary Completion Date February 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
Percent change from baseline in DXA BMD at the lumbar spine at Month 12 [ Time Frame: 12 Months ]
To evaluate the effect of treatment with romosozumab for 12 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy x-ray abosorptiometry (DXA) in men with osteoporosis.
Change History Complete list of historical versions of study NCT02186171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • Percent change from baseline in DXA BMD at the femoral neck and total hip at Month 12. [ Time Frame: 12 Months ]
    To evaluate the effect of treatment with romosozumab for 12 months compated with placebo on the percent changes in DXA BMD at the total hip and femoral neck.
  • Percent change from baseline in DXA BMD at the lumbar spine, femoral neck, and total hip at Month 6. [ Time Frame: Month 6 ]
    To evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in DXA BMD at the lumbar spine, total hip, and femoral neck.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: July 8, 2014)
Percent change from baseline in bone turnover markers CTX and P1NP at Month 1, 3, 6, and 12. [ Time Frame: Month 1, 3, 6, and 12 ]
Percent changes in bone turnover markers (BTM); bone formation marker procollagen type 1 N-telopeptide (P1NP) and bone resorption marker serum type I collagen C-telopeptide (CTX).
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis in Men
Intervention  ICMJE
  • Biological: Romosozumab
    Administered by subcutaneous injection once a month.
    Other Names:
    • AMG 785
    • EVENITY™
  • Drug: Placebo
    Administered by subcutaneous injection once a month.
Study Arms  ICMJE
  • Experimental: Romosozumab
    Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
    Intervention: Biological: Romosozumab
  • Placebo Comparator: Placebo
    Participants received placebo subcutaneous injections once a month for 12 months.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2015)
245
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
225
Actual Study Completion Date  ICMJE April 20, 2016
Actual Primary Completion Date February 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Colombia,   Czechia,   Denmark,   Japan,   Mexico,   Poland,   Russian Federation,   Switzerland,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02186171
Other Study ID Numbers  ICMJE 20110174
2013-005551-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP