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

Amgen245 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

245

Conditions

Osteoporosis in Men

Interventions

RomosozumabBIOLOGICAL

Administered by subcutaneous injection once a month.

PlaceboDRUG

Administered by subcutaneous injection once a month.

Eligibility

Sex: MALEMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 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.

Time frame: Baseline and month 12

Secondary Outcomes

Percent Change From Baseline in BMD at the Total Hip at Month 12

Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time frame: Baseline and month 12

Percent Change From Baseline in BMD at the Femoral Neck at 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.

Time frame: Baseline and month 12

Percent Change From Baseline in Lumbar Spine BMD at 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.

Time frame: Baseline and month 6

Percent Change From Baseline in BMD at the Total Hip at Month 6

Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time frame: Baseline and month 6

Percent Change From Baseline in BMD at the Femoral Neck at Month 6

Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Time frame: Baseline and month 6

Data from ClinicalTrials.gov

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