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A Randomized, Place...
A Randomized, Placebo-Controlled Study of the Effects of Denosumab for the Treatment of Men with Low Bone Mineral Density
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Orwoll, Eric (author)
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Teglbjrg, Christence S. (author)
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Langdahl, Bente L. (author)
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Chapurlat, Roland (author)
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Czerwinski, Edward (author)
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Kendler, David L. (author)
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Reginster, Jean-Yves (author)
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Kivitz, Alan (author)
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Lewiecki, E. Michael (author)
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Miller, Paul D. (author)
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Bolognese, Michael A. (author)
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McClung, Michael R. (author)
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Bone, Henry G. (author)
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- Ljunggren, Östen (author)
- Uppsala universitet,Metabola bensjukdomar
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Abrahamsen, Bo (author)
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Gruntmanis, Ugis (author)
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Yang, Yu-Ching (author)
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Wagman, Rachel B. (author)
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Siddhanti, Suresh (author)
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Grauer, Andreas (author)
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Hall, Jesse W. (author)
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Boonen, Steven (author)
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(creator_code:org_t)
- The Endocrine Society, 2012
- 2012
- English.
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In: Journal of Clinical Endocrinology and Metabolism. - : The Endocrine Society. - 0021-972X .- 1945-7197. ; 97:9, s. 3161-3169
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https://academic.oup...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
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- By the author/editor
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Orwoll, Eric
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Teglbjrg, Christ ...
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Langdahl, Bente ...
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Chapurlat, Rolan ...
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Czerwinski, Edwa ...
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Kendler, David L ...
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show more...
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Reginster, Jean- ...
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Kivitz, Alan
-
Lewiecki, E. Mic ...
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Miller, Paul D.
-
Bolognese, Micha ...
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McClung, Michael ...
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Bone, Henry G.
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Ljunggren, Östen
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Abrahamsen, Bo
-
Gruntmanis, Ugis
-
Yang, Yu-Ching
-
Wagman, Rachel B ...
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Siddhanti, Sures ...
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Grauer, Andreas
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Hall, Jesse W.
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Boonen, Steven
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show less...
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Journal of Clini ...
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Uppsala University