A Randomized, Placebo-Controlled Study of the Effects of Denosumab for the Treatment of Men with Low Bone Mineral Density

被引：152

作者：

Orwoll, Eric ^{[1
]}

Teglbjrg, Christence S. ^{[2
]}

Langdahl, Bente L. ^{[3
]}

Chapurlat, Roland ^{[4
]}

Czerwinski, Edward ^{[5
]}

Kendler, David L. ^{[6
]}

Reginster, Jean-Yves ^{[8
]}

Kivitz, Alan ^{[7
]}

Lewiecki, E. Michael ^{[9
]}

Miller, Paul D. ^{[10
]}

Bolognese, Michael A. ^{[11
]}

McClung, Michael R. ^{[12
]}

Bone, Henry G. ^{[13
]}

Ljunggren, Oesten ^{[14
]}

Abrahamsen, Bo ^{[15
,16
,21
,22
]}

Gruntmanis, Ugis ^{[17
,18
]}

Yang, Yu-Ching ^{[19
]}

Wagman, Rachel B. ^{[19
]}

Siddhanti, Suresh ^{[19
]}

Grauer, Andreas ^{[19
]}

Hall, Jesse W. ^{[19
]}

Boonen, Steven ^{[20
]}

机构：

[1] Oregon Hlth & Sci Univ, Portland, OR 97239 USA

[2] Ctr Clin & Basic Res, DK-2750 Ballerup, Denmark

[3] Aarhus Univ Hosp, DK-8000 Aarhus, Denmark

[4] Univ Lyon, Hop Edouard Herriot, INSERM, UMR 1033, F-69003 Lyon, France

[5] Krakow Med Ctr, PL-31501 Krakow, Poland

[6] Univ British Columbia, Vancouver, BC V6H 3X8, Canada

[7] Altoona Ctr Clin Res, Duncansville, PA 16635 USA

[8] Univ Liege, B-4020 Liege, Belgium

[9] New Mexico Clin Res & Osteoporosis Ctr, Albuquerque, NM 87106 USA

[10] Colorado Ctr Bone Res, Lakewood, CO 80227 USA

[11] Bethesda Hlth Res Ctr, Bethesda, MD 20817 USA

[12] Oregon Osteoporosis Ctr, Portland, OR 97213 USA

[13] Michigan Bone & Mineral Clin, Detroit, MI 48236 USA

[14] Uppsala Univ, S-75185 Uppsala, Sweden

[15] Gentofte Univ Hosp, DK-2900 Hellerup, Denmark

[16] Univ So Denmark, DK-2900 Hellerup, Denmark

[17] Univ Texas SW, Dallas, TX 75216 USA

[18] Dallas Vet Affairs Med Ctr, Dallas, TX 75216 USA

[19] Amgen Inc, Thousand Oaks, CA 91320 USA

[20] Katholieke Univ Leuven, B-3000 Louvain, Belgium

[21] Gentofte Univ Hosp, DK-5000 Odense, Denmark

[22] Univ So Denmark, DK-5000 Odense, Denmark

来源：

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM | 2012年 / 97卷 / 09期

关键词：

POSTMENOPAUSAL WOMEN; EXCESS MORTALITY; DOUBLE-BLIND; OSTEOPOROSIS; ALENDRONATE; FRACTURE; TURNOVER; BURDEN;

D O I：

10.1210/jc.2012-1569

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (J Clin Endocrinol Metab 97: 3161-3169, 2012)

引用

页码：3161 / 3169

页数：9

共 32 条

[1] Effects of denosumab on bone mineral density and bone turnover in postmenopausal women [J].