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Showing content from https://pubmed.ncbi.nlm.nih.gov/22723310 below:

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

Randomized Controlled Trial

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 Christence S Teglbjærg, Bente L Langdahl, Roland Chapurlat, Edward Czerwinski, David L Kendler, Jean-Yves Reginster, Alan Kivitz, E Michael Lewiecki, Paul D Miller, Michael A Bolognese, Michael R McClung, Henry G Bone, Östen Ljunggren, Bo Abrahamsen, Ugis Gruntmanis, Yu-Ching Yang, Rachel B Wagman, Suresh Siddhanti, Andreas Grauer, Jesse W Hall, Steven Boonen

Affiliations

Affiliation

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

PMID: 22723310
DOI: 10.1210/jc.2012-1569

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Randomized Controlled Trial

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

Eric Orwoll et al. J Clin Endocrinol Metab. 2012 Sep.

doi: 10.1210/jc.2012-1569. Epub 2012 Jun 21. Authors Eric Orwoll¹, Christence S Teglbjærg, Bente L Langdahl, Roland Chapurlat, Edward Czerwinski, David L Kendler, Jean-Yves Reginster, Alan Kivitz, E Michael Lewiecki, Paul D Miller, Michael A Bolognese, Michael R McClung, Henry G Bone, Östen Ljunggren, Bo Abrahamsen, Ugis Gruntmanis, Yu-Ching Yang, Rachel B Wagman, Suresh Siddhanti, Andreas Grauer, Jesse W Hall, Steven Boonen Affiliation

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

PMID: 22723310
DOI: 10.1210/jc.2012-1569

Item in Clipboard

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.

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