Completed

NCT Number: NCT02186171

A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus 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.

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Key information

Conditions

Osteoporosis in Men

Age range

55 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Genk, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Romosozumab

Biological

Administered by subcutaneous injection once a month.

Other names: AMG 785, EVENITY™

Placebo

Drug

Administered by subcutaneous injection once a month.

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Acronym: BRIDGE

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 10, 2014
Registry last updated: May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.