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Title: A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density
Authors: Orwoll, Eric ×
Teglbjærg, Christence S
Langdahl, Bente L
Chapurlat, Roland
Czerwinski, Edward
Kendler, David L
Reginster, Jean-Yves
Kivitz, Alan
Lewiecki, E Michael
Miller, Paul D
Bolognese, Michael A
McClung, Michael R
Bone, Henry G
Ljunggren, Osten
Abrahamsen, Bo
Gruntmanis, Ugis
Yang, Yu-Ching
Wagman, Rachel B
Siddhanti, Suresh
Grauer, Andreas
Hall, Jesse W
Boonen, Steven #
Issue Date: Sep-2012
Publisher: Issued for the Endocrine Society by the Williams & Wilkins Co.
Series Title: Journal of Clinical Endocrinology & Metabolism vol:97 issue:9 pages:3161-9
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.
ISSN: 0021-972X
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Gerontology and Geriatrics
× corresponding author
# (joint) last author

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