CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
60 mg denosumab +1 moredrug
Likely dose
60 mg denosumabfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00980174
NCT00980174Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Denosumab Versus Placebo in Males With Low Bone Mineral Density

Amgen·interventional·Posted Sep 18, 2009·Updated Oct 17, 2018

In Brief

A Phase 3 clinical trial evaluating 60 mg denosumab and Placebo for Low Bone Mass and 4 related conditions. Completed, enrolled 242 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Bone Mass, Low Bone Mineral Density, Males With Osteoporosis, Osteopenia, Osteoporosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2009
Enrollment StartOct 1, 2009
Primary CompletionJun 21, 2011
Study CompletionMay 23, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.8 years ago

Interventions

60 mg denosumabdrug

60 mg denosumab (SC injection every 6 months)

Placeboother

Placebo for denosumab (SC injection every 6 months)