Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension

被引：274

作者：

Papapoulos, Socrates ^{[1
]}

Chapurlat, Roland ^{[2
]}

Libanati, Cesar ^{[3
]}

Brandi, Maria Luisa ^{[4
]}

Brown, Jacques P. ^{[5
,6
]}

Czerwinski, Edward ^{[7
]}

Krieg, Marc-Antoine ^{[8
]}

Man, Zulema ^{[9
]}

Mellstrom, Dan ^{[10
]}

Radominski, Sebastiao C. ^{[11
]}

Reginster, Jean-Yves ^{[12
]}

Resch, Heinrich ^{[13
]}

Roman Ivorra, Jose A. ^{[14
]}

Roux, Christian ^{[15
]}

Vittinghoff, Eric ^{[16
]}

Austin, Matthew ^{[3
]}

Daizadeh, Nadia ^{[3
]}

Bradley, Michelle N. ^{[3
]}

Grauer, Andreas ^{[3
]}

Cummings, Steven R. ^{[17
]}

Bone, Henry G. ^{[18
]}

机构：

[1] Leiden Univ, Med Ctr, Dept Endocrinol & Metab Dis, Leiden, Netherlands

[2] Univ Lyon, INSERM, UMR 1033, Lyon, France

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

[4] Univ Florence, Dept Internal Med, Florence, Italy

[5] Univ Laval, Dept Med, Quebec City, PQ G1K 7P4, Canada

[6] Univ Laval, Div Rheumatol, CHUQ Res Ctr, Quebec City, PQ, Canada

[7] Krakow Med Ctr, Krakow, Poland

[8] Univ Lausanne Hosp, Bone & Joint Dept, Lausanne, Switzerland

[9] Ctr TIEMPO, Div Endocrinol, Buenos Aires, DF, Argentina

[10] Sahlgrens Univ Hosp, Ctr Bone Res, Osteoporosis Clin, Gothenburg, Sweden

[11] Univ Fed Parana, Dept Internal Med, BR-80060000 Curitiba, Parana, Brazil

[12] Univ Liege, Bone & Cartilage Metab Unit, Liege, Belgium

[13] St Vincent Hosp, Med Dept 2, Vienna, Austria

[14] Hosp Univ La Fe, Rheumatol Unit, Valencia, Spain

[15] Paris Descartes Univ, Cochin Hosp, Dept Rheumatol, Paris, France

[16] Univ Calif San Francisco, Dept Epidemiol & Biostat, San Francisco, CA 94143 USA

[17] San Francisco Coordinating Ctr, CPMC Res Inst, San Francisco, CA USA

[18] Michigan Bone & Mineral Clin, Detroit, MI USA

来源：

JOURNAL OF BONE AND MINERAL RESEARCH | 2012年 / 27卷 / 03期

关键词：

BONE MINERAL DENSITY; BONE TURNOVER MARKERS; DENOSUMAB; FRACTURE; PIVOTAL FRACTURE TRIAL EXTENSION; PLACEBO; FRACTURES; DENSITY; TRIALS;

D O I：

10.1002/jbmr.1479

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

The 3-year FREEDOM trial assessed the efficacy and safety of 60?mg denosumab every 6 months for the treatment of postmenopausal women with osteoporosis. Participants who completed the FREEDOM trial were eligible to enter an extension to continue the evaluation of denosumab efficacy and safety for up to 10 years. For the extension results presented here, women from the FREEDOM denosumab group had 2 more years of denosumab treatment (long-term group) and those from the FREEDOM placebo group had 2 years of denosumab exposure (cross-over group). We report results for bone turnover markers (BTMs), bone mineral density (BMD), fracture rates, and safety. A total of 4550 women enrolled in the extension (2343 long-term; 2207 cross-over). Reductions in BTMs were maintained (long-term group) or occurred rapidly (cross-over group) following denosumab administration. In the long-term group, lumbar spine and total hip BMD increased further, resulting in 5-year gains of 13.7% and 7.0%, respectively. In the cross-over group, BMD increased at the lumbar spine (7.7%) and total hip (4.0%) during the 2-year denosumab treatment. Yearly fracture incidences for both groups were below rates observed in the FREEDOM placebo group and below rates projected for a virtual untreated twin cohort. Adverse events did not increase with long-term denosumab administration. Two adverse events in the cross-over group were adjudicated as consistent with osteonecrosis of the jaw. Five-year denosumab treatment of women with postmenopausal osteoporosis maintained BTM reduction and increased BMD, and was associated with low fracture rates and a favorable risk/benefit profile. (c) 2012 American Society for Bone and Mineral Research

引用

页码：694 / 701

页数：8

共 14 条

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Ten years' experience with alendronate for osteoporosis in postmenopausal women [J].