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WFRF:(Siddhanti Suresh)
 

Sökning: WFRF:(Siddhanti Suresh) > A Randomized, Place...

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FältnamnIndikatorerMetadata
00003570naa a2200517 4500
001oai:DiVA.org:uu-183225
003SwePub
008121023s2012 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-1832252 URI
0247 a https://doi.org/10.1210/jc.2012-15692 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Orwoll, Eric4 aut
2451 0a A Randomized, Placebo-Controlled Study of the Effects of Denosumab for the Treatment of Men with Low Bone Mineral Density
264 1b The Endocrine Society,c 2012
338 a print2 rdacarrier
520 a 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.
7001 a Teglbjrg, Christence S.4 aut
7001 a Langdahl, Bente L.4 aut
7001 a Chapurlat, Roland4 aut
7001 a Czerwinski, Edward4 aut
7001 a Kendler, David L.4 aut
7001 a Reginster, Jean-Yves4 aut
7001 a Kivitz, Alan4 aut
7001 a Lewiecki, E. Michael4 aut
7001 a Miller, Paul D.4 aut
7001 a Bolognese, Michael A.4 aut
7001 a McClung, Michael R.4 aut
7001 a Bone, Henry G.4 aut
7001 a Ljunggren, Östenu Uppsala universitet,Metabola bensjukdomar4 aut0 (Swepub:uu)osteljun
7001 a Abrahamsen, Bo4 aut
7001 a Gruntmanis, Ugis4 aut
7001 a Yang, Yu-Ching4 aut
7001 a Wagman, Rachel B.4 aut
7001 a Siddhanti, Suresh4 aut
7001 a Grauer, Andreas4 aut
7001 a Hall, Jesse W.4 aut
7001 a Boonen, Steven4 aut
7102 a Uppsala universitetb Metabola bensjukdomar4 org
7730 t Journal of Clinical Endocrinology and Metabolismd : The Endocrine Societyg 97:9, s. 3161-3169q 97:9<3161-3169x 0021-972Xx 1945-7197
8564 u https://academic.oup.com/jcem/article-pdf/97/9/3161/9047746/jcem3161.pdf
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-183225
8564 8u https://doi.org/10.1210/jc.2012-1569

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