Comparison of the Effect of Denosumab and Alendronate on BMD and Biochemical Markers of Bone Turnover in Postmenopausal Women With Low Bone Mass: A Randomized, Blinded, Phase 3 Trial

Denosumab is a fully human monoclonal antibody that inhibits bone resorption by neutralizing RANKL, a key mediator of osteoclast formation, function, and survival. This phase 3, multicenter, double‐blind study compared the efficacy and safety of denosumab with alendronate in postmenopausal women wit...

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Veröffentlicht in:Journal of bone and mineral research 2009-01, Vol.24 (1), p.153-161
Hauptverfasser: Brown, Jacques P, Prince, Richard L, Deal, Chad, Recker, Robert R, Kiel, Douglas P, de Gregorio, Luiz H, Hadji, Peyman, Hofbauer, Lorenz C, Álvaro‐Gracia, Jose M, Wang, Huei, Austin, Matthew, Wagman, Rachel B, Newmark, Richard, Libanati, Cesar, San Martin, Javier, Bone, Henry G
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container_issue 1
container_start_page 153
container_title Journal of bone and mineral research
container_volume 24
creator Brown, Jacques P
Prince, Richard L
Deal, Chad
Recker, Robert R
Kiel, Douglas P
de Gregorio, Luiz H
Hadji, Peyman
Hofbauer, Lorenz C
Álvaro‐Gracia, Jose M
Wang, Huei
Austin, Matthew
Wagman, Rachel B
Newmark, Richard
Libanati, Cesar
San Martin, Javier
Bone, Henry G
description Denosumab is a fully human monoclonal antibody that inhibits bone resorption by neutralizing RANKL, a key mediator of osteoclast formation, function, and survival. This phase 3, multicenter, double‐blind study compared the efficacy and safety of denosumab with alendronate in postmenopausal women with low bone mass. One thousand one hundred eighty‐nine postmenopausal women with a T‐score ≤ −2.0 at the lumbar spine or total hip were randomized 1:1 to receive subcutaneous denosumab injections (60 mg every 6 mo [Q6M]) plus oral placebo weekly (n = 594) or oral alendronate weekly (70 mg) plus subcutaneous placebo injections Q6M (n = 595). Changes in BMD were assessed at the total hip, femoral neck, trochanter, lumbar spine, and one‐third radius at 6 and 12 mo and in bone turnover markers at months 1, 3, 6, 9, and 12. Safety was evaluated by monitoring adverse events and laboratory values. At the total hip, denosumab significantly increased BMD compared with alendronate at month 12 (3.5% versus 2.6%; p < 0.0001). Furthermore, significantly greater increases in BMD were observed with denosumab treatment at all measured skeletal sites (12‐mo treatment difference: 0.6%, femoral neck; 1.0%, trochanter; 1.1%, lumbar spine; 0.6%, one‐third radius; p ≤ 0.0002 all sites). Denosumab treatment led to significantly greater reduction of bone turnover markers compared with alendronate therapy. Adverse events and laboratory values were similar for denosumab‐ and alendronate‐treated subjects. Denosumab showed significantly larger gains in BMD and greater reduction in bone turnover markers compared with alendronate. The overall safety profile was similar for both treatments.
doi_str_mv 10.1359/jbmr.0809010
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This phase 3, multicenter, double‐blind study compared the efficacy and safety of denosumab with alendronate in postmenopausal women with low bone mass. One thousand one hundred eighty‐nine postmenopausal women with a T‐score ≤ −2.0 at the lumbar spine or total hip were randomized 1:1 to receive subcutaneous denosumab injections (60 mg every 6 mo [Q6M]) plus oral placebo weekly (n = 594) or oral alendronate weekly (70 mg) plus subcutaneous placebo injections Q6M (n = 595). Changes in BMD were assessed at the total hip, femoral neck, trochanter, lumbar spine, and one‐third radius at 6 and 12 mo and in bone turnover markers at months 1, 3, 6, 9, and 12. Safety was evaluated by monitoring adverse events and laboratory values. At the total hip, denosumab significantly increased BMD compared with alendronate at month 12 (3.5% versus 2.6%; p &lt; 0.0001). Furthermore, significantly greater increases in BMD were observed with denosumab treatment at all measured skeletal sites (12‐mo treatment difference: 0.6%, femoral neck; 1.0%, trochanter; 1.1%, lumbar spine; 0.6%, one‐third radius; p ≤ 0.0002 all sites). Denosumab treatment led to significantly greater reduction of bone turnover markers compared with alendronate therapy. Adverse events and laboratory values were similar for denosumab‐ and alendronate‐treated subjects. Denosumab showed significantly larger gains in BMD and greater reduction in bone turnover markers compared with alendronate. The overall safety profile was similar for both treatments.</description><identifier>ISSN: 0884-0431</identifier><identifier>EISSN: 1523-4681</identifier><identifier>DOI: 10.1359/jbmr.0809010</identifier><identifier>CODEN: JBMREJ</identifier><language>eng</language><publisher>Washington, DC: John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR)</publisher><subject>alendronate ; biochemical markers of bone turnover ; Biological and medical sciences ; BMD ; denosumab ; Fundamental and applied biological sciences. 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Furthermore, significantly greater increases in BMD were observed with denosumab treatment at all measured skeletal sites (12‐mo treatment difference: 0.6%, femoral neck; 1.0%, trochanter; 1.1%, lumbar spine; 0.6%, one‐third radius; p ≤ 0.0002 all sites). Denosumab treatment led to significantly greater reduction of bone turnover markers compared with alendronate therapy. Adverse events and laboratory values were similar for denosumab‐ and alendronate‐treated subjects. Denosumab showed significantly larger gains in BMD and greater reduction in bone turnover markers compared with alendronate. The overall safety profile was similar for both treatments.</description><subject>alendronate</subject><subject>biochemical markers of bone turnover</subject><subject>Biological and medical sciences</subject><subject>BMD</subject><subject>denosumab</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>postmenopausal osteoporosis</subject><subject>Skeleton and joints</subject><subject>Vertebrates: osteoarticular system, musculoskeletal system</subject><issn>0884-0431</issn><issn>1523-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><recordid>eNp9kc9u1DAQhy0EEkvh1gfwBU5NsePEdbhttn8A7YqqWtRjNHHGWpfEXuyEqjwYz4fTXXFEPthjffNpND9CTjk756KsPj60QzhnilWMsxdkwctcZIVU_CVZMKWKjBWCvyZvYnxgjMlSygX5s_LDHoKN3lFv6LhDemUM6nGuLtH5OA3QUnAdXfbouuAdjEgTXW8un79r6_UOB6uhpxsIPzDEubf2Dul2Cs7_wkCto7c-jkMS7mGKCb33qaD3dtzRtX884BuI8RNd0rvk9YP9jd0ZrXvruvlxu4OIVNBtsNC_Ja8M9BHfHe8T8v36arv6nK2_3XxZLdeZFkqxrNOt7jS_0KaVrVESqnSKyuRYthKhUiVH4K3RrVCYt0UOopMGIO2wYPJCixPy4eDdB_9zwjg2g40a-x4c-ik2vJJSMSUTeHYAdfAxBjTNPtgBwlPDWTOH08zhNMdwEv7-6IWYFmcCOG3jv56cpdGk5IlTB-7R9vj0X2fztd7clbJkecF4zsRfztyiyw</recordid><startdate>200901</startdate><enddate>200901</enddate><creator>Brown, Jacques P</creator><creator>Prince, Richard L</creator><creator>Deal, Chad</creator><creator>Recker, Robert R</creator><creator>Kiel, Douglas P</creator><creator>de Gregorio, Luiz H</creator><creator>Hadji, Peyman</creator><creator>Hofbauer, Lorenz C</creator><creator>Álvaro‐Gracia, Jose M</creator><creator>Wang, Huei</creator><creator>Austin, Matthew</creator><creator>Wagman, Rachel B</creator><creator>Newmark, Richard</creator><creator>Libanati, Cesar</creator><creator>San Martin, Javier</creator><creator>Bone, Henry G</creator><general>John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR)</general><general>Wiley</general><scope>IQODW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope></search><sort><creationdate>200901</creationdate><title>Comparison of the Effect of Denosumab and Alendronate on BMD and Biochemical Markers of Bone Turnover in Postmenopausal Women With Low Bone Mass: A Randomized, Blinded, Phase 3 Trial</title><author>Brown, Jacques P ; Prince, Richard L ; Deal, Chad ; Recker, Robert R ; Kiel, Douglas P ; de Gregorio, Luiz H ; Hadji, Peyman ; Hofbauer, Lorenz C ; Álvaro‐Gracia, Jose M ; Wang, Huei ; Austin, Matthew ; Wagman, Rachel B ; Newmark, Richard ; Libanati, Cesar ; San Martin, Javier ; Bone, Henry G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3880-dcbcdc17cfb6bf86a9a9a49f2e5b6ea9851ea1bfcb38e2b42a3d6faa0804067c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>alendronate</topic><topic>biochemical markers of bone turnover</topic><topic>Biological and medical sciences</topic><topic>BMD</topic><topic>denosumab</topic><topic>Fundamental and applied biological sciences. 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subjects alendronate
biochemical markers of bone turnover
Biological and medical sciences
BMD
denosumab
Fundamental and applied biological sciences. Psychology
postmenopausal osteoporosis
Skeleton and joints
Vertebrates: osteoarticular system, musculoskeletal system
title Comparison of the Effect of Denosumab and Alendronate on BMD and Biochemical Markers of Bone Turnover in Postmenopausal Women With Low Bone Mass: A Randomized, Blinded, Phase 3 Trial
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