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Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis

NCT00980174 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2018-10-17

Study results available
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Summary

The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men with low bone mineral density, the mean percent change in lumbar spine bone mineral density at 12 months in subjects receiving denosumab will be greater than in subjects receiving placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor Activator of Nuclear Factor (RANK) Ligand that can bind and neutralize the activity of human RANK Ligand similar to the action of endogenous osteoprotegerin.

Conditions

  • Low Bone Mass
  • Low Bone Mineral Density
  • Males With Osteoporosis
  • Osteopenia
  • Osteoporosis

Interventions

DRUG

60 mg denosumab

60 mg denosumab (SC injection every 6 months)

OTHER

Placebo

Placebo for denosumab (SC injection every 6 months)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-01
Primary Completion
2011-06-21
Completion
2012-05-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980174 on ClinicalTrials.gov