Article (Scientific journals)
A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density
Orwoll, E.; Teglbjærg, C. S.; Langdahl, B. L. et al.
2012In Journal of Clinical Endocrinology and Metabolism, 97 (9), p. 3161-3169
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Keywords :
Absorptiometry, Photon; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Biological Markers; Bone and Bones; Bone Density; Bone Remodeling; Double-Blind Method; Humans; Male; Middle Aged; Testosterone
Abstract :
[en] 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. Copyright © 2012 by The Endocrine Society.
Disciplines :
General & internal medicine
Author, co-author :
Orwoll, E.;  Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, United States
Teglbjærg, C. S.;  Center for Clinical and Basic Research, Ballerup 2750, Denmark
Langdahl, B. L.;  Aarhus University Hospital, Aarhus 8000, Denmark
Chapurlat, R.;  Institut National de la Santeet de la Recherche Medicale Unite Mixte de Recherche 1033, Université de Lyon, Hôpital Edouard Herriot, Lyon 69003, France
Czerwinski, E.;  Krakow Medical Center, Krakow 31-501, Poland
Kendler, D. L.;  University of British Columbia, Vancouver, BC V6H 3X8, Canada
REGINSTER, Jean-Yves  ;  Centre Hospitalier Universitaire de Liège - CHU > Médecine de l'appareil locomoteur
Kivitz, A.;  Altoona Center for Clinical Research, Duncansville, PA 16635, United States
Lewiecki, E. M.;  New Mexico Clinical Research and Osteoporosis Center, Albuquerque, NM 87106, United States
Miller, P. D.;  Colorado Center for Bone Research, Lakewood, CO 80227, United States
Bolognese, M. A.;  Bethesda Health Research Center, Bethesda, MD 20817, United States
McClung, M. R.;  Oregon Osteoporosis Center, Portland, OR 97213, United States
Bone, H. G.;  Michigan Bone and Mineral Clinic, Detroit, MI 48236, United States
Ljunggren, Ö.;  Uppsala University, Uppsala 75185, Sweden
Abrahamsen, B.;  University of Southern Denmark, Gentofte Hospital, Odense 5000, Denmark, University of Southern Denmark, Gentofte Hospital, Hellerup 2900, Denmark
Gruntmanis, U.;  Dallas Veterans Affairs Medical Center, University of Texas Southwestern, Dallas, TX 75216, United States
Yang, Y.-C.;  Amgen Inc., Thousand Oaks, CA 91320, United States
Wagman, R. B.;  Amgen Inc., Thousand Oaks, CA 91320, United States
Siddhanti, S.;  Amgen Inc., Thousand Oaks, CA 91320, United States
Grauer, A.;  Amgen Inc., Thousand Oaks, CA 91320, United States
Hall, J. W.;  Amgen Inc., Thousand Oaks, CA 91320, United States
Boonen, S.;  Leuven University, Leuven 3000, Belgium
More authors (12 more) Less
Language :
English
Title :
A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density
Publication date :
2012
Journal title :
Journal of Clinical Endocrinology and Metabolism
ISSN :
0021-972X
eISSN :
1945-7197
Publisher :
Oxford University Press, New York, United States - New York
Volume :
97
Issue :
9
Pages :
3161-3169
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 18 October 2013

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