Format

Send to:

Choose Destination
See comment in PubMed Commons below
J Clin Endocrinol Metab. 2012 Sep;97(9):3161-9. doi: 10.1210/jc.2012-1569. Epub 2012 Jun 21.

A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density.

Author information

  • 1Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, Oregon 97239, USA. orwoll@ohsu.edu

Abstract

CONTEXT:

Men with low bone mineral density (BMD) were treated with denosumab.

OBJECTIVE:

Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment.

DESIGN, SUBJECTS, AND INTERVENTION:

This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD.

MAIN OUTCOME MEASURE:

The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12.

RESULTS:

Of the 242 randomized subjects (mean age 65 yr), 228 (94.2%) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7% at the LS, 2.4% at the total hip, 2.1% at the femoral neck, 3.1% at the trochanter, and 0.6% at the one third radius (adjusted P ≤ 0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P < 0.0001). The incidence of adverse events was similar between groups.

CONCLUSIONS:

One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00980174.

PMID:
22723310
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Atypon
    Loading ...
    Write to the Help Desk