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

Amgen

Status and phase: Completed; Phase 3

Conditions: Osteoporosis in Men

Treatments: Biological: Romosozumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02186171

20110174

2013-005551-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: Male

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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245 participants in 2 patient groups, including a placebo group

Romosozumab

Experimental group

Description:

Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Treatment:

Biological: Romosozumab

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous injections once a month for 12 months.

Treatment:

Drug: Placebo