The Effect of Discontinuing Treatment With Blosozumab: Follow‐up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density
ABSTRACT Administration of blosozumab, a humanized monoclonal antibody that binds sclerostin, increases bone formation and bone mineral density (BMD) in postmenopausal women with low BMD. To evaluate the effect of discontinuing blosozumab, we studied women enrolled in a 1‐year randomized, placebo‐co...
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Veröffentlicht in: | Journal of bone and mineral research 2015-09, Vol.30 (9), p.1717-1725 |
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creator | Recknor, Christopher P Recker, Robert R Benson, Charles T Robins, Deborah A Chiang, Alan Y Alam, Jahangir Hu, Leijun Matsumoto, Toshio Sowa, Hideaki Sloan, John H Konrad, Robert J Mitlak, Bruce H Sipos, Adrien A |
description | ABSTRACT
Administration of blosozumab, a humanized monoclonal antibody that binds sclerostin, increases bone formation and bone mineral density (BMD) in postmenopausal women with low BMD. To evaluate the effect of discontinuing blosozumab, we studied women enrolled in a 1‐year randomized, placebo‐controlled phase 2 trial for an additional year after they completed treatment. Of the 120 women initially enrolled in the study, 106 women completed treatment and continued into follow‐up; 88 women completed 1 year of follow‐up. At the beginning of follow‐up, groups remained balanced for age, race, and body mass index, but lumbar spine and total hip BMD were increased in prior blosozumab groups, reflecting an anabolic treatment effect. At the end of follow‐up, 1 year after discontinuing treatment, lumbar spine BMD remained significantly greater than placebo in women initially treated with blosozumab 270 mg every 2 weeks (Q2W) and blosozumab 180 mg Q2W (6.9% and 3.6% above baseline, respectively). Total hip BMD also declined after discontinuation of treatment but at 1 year after treatment remained significantly greater than placebo in women initially treated with blosozumab 270 mg Q2W and blosozumab 180 mg Q2W (3.9% and 2.6% above baseline, respectively). During follow‐up, median serum P1NP was not consistently different between the prior blosozumab groups and placebo. A similar pattern was apparent for median serum C‐terminal telopeptide of type 1 collagen (CTx) levels, with more variability. Mean serum total sclerostin concentration increased with blosozumab, indicating target engagement, and declined to baseline after discontinuation. There were no adverse events considered related to prior treatment with blosozumab. Anti‐drug antibodies generally declined in patients who had detectable levels during prior treatment. These findings support the continued study of blosozumab as an anabolic therapy for treatment of osteoporosis. © 2015 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR). |
doi_str_mv | 10.1002/jbmr.2489 |
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Administration of blosozumab, a humanized monoclonal antibody that binds sclerostin, increases bone formation and bone mineral density (BMD) in postmenopausal women with low BMD. To evaluate the effect of discontinuing blosozumab, we studied women enrolled in a 1‐year randomized, placebo‐controlled phase 2 trial for an additional year after they completed treatment. Of the 120 women initially enrolled in the study, 106 women completed treatment and continued into follow‐up; 88 women completed 1 year of follow‐up. At the beginning of follow‐up, groups remained balanced for age, race, and body mass index, but lumbar spine and total hip BMD were increased in prior blosozumab groups, reflecting an anabolic treatment effect. At the end of follow‐up, 1 year after discontinuing treatment, lumbar spine BMD remained significantly greater than placebo in women initially treated with blosozumab 270 mg every 2 weeks (Q2W) and blosozumab 180 mg Q2W (6.9% and 3.6% above baseline, respectively). Total hip BMD also declined after discontinuation of treatment but at 1 year after treatment remained significantly greater than placebo in women initially treated with blosozumab 270 mg Q2W and blosozumab 180 mg Q2W (3.9% and 2.6% above baseline, respectively). During follow‐up, median serum P1NP was not consistently different between the prior blosozumab groups and placebo. A similar pattern was apparent for median serum C‐terminal telopeptide of type 1 collagen (CTx) levels, with more variability. Mean serum total sclerostin concentration increased with blosozumab, indicating target engagement, and declined to baseline after discontinuation. There were no adverse events considered related to prior treatment with blosozumab. Anti‐drug antibodies generally declined in patients who had detectable levels during prior treatment. These findings support the continued study of blosozumab as an anabolic therapy for treatment of osteoporosis. © 2015 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).</description><identifier>ISSN: 0884-0431</identifier><identifier>EISSN: 1523-4681</identifier><identifier>DOI: 10.1002/jbmr.2489</identifier><identifier>PMID: 25707611</identifier><identifier>CODEN: JBMREJ</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Aged ; ANABOLICS ; Antibodies, Monoclonal - chemistry ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - blood ; BLOSOZUMAB ; Body mass index ; Bone Density ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - blood ; Bone growth ; Bone mineral density ; Bone Morphogenetic Proteins - blood ; Bone Morphogenetic Proteins - immunology ; Bone Resorption ; Clinical trials ; Collagen ; Double-Blind Method ; Drug Administration Schedule ; DXA ; Female ; Follow-Up Studies ; Genetic Markers - immunology ; Hip ; Humans ; Middle Aged ; Monoclonal antibodies ; Osteogenesis ; OSTEOPOROSIS ; Osteoporosis, Postmenopausal - drug therapy ; Post-menopause ; Postmenopause ; SCLEROSTIN ANTIBODY ; SOST protein ; Spine (lumbar) ; Steroids - chemistry ; Time Factors</subject><ispartof>Journal of bone and mineral research, 2015-09, Vol.30 (9), p.1717-1725</ispartof><rights>2015 The Authors. published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).</rights><rights>2015 American Society for Bone and Mineral Research.</rights><rights>2015 American Society for Bone and Mineral Research</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4499-19777649417810dd098904458df77e572d56d9e0f0d3bb9bb156bdb04311152f3</citedby><cites>FETCH-LOGICAL-c4499-19777649417810dd098904458df77e572d56d9e0f0d3bb9bb156bdb04311152f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjbmr.2489$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjbmr.2489$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25707611$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Recknor, Christopher P</creatorcontrib><creatorcontrib>Recker, Robert R</creatorcontrib><creatorcontrib>Benson, Charles T</creatorcontrib><creatorcontrib>Robins, Deborah A</creatorcontrib><creatorcontrib>Chiang, Alan Y</creatorcontrib><creatorcontrib>Alam, Jahangir</creatorcontrib><creatorcontrib>Hu, Leijun</creatorcontrib><creatorcontrib>Matsumoto, Toshio</creatorcontrib><creatorcontrib>Sowa, Hideaki</creatorcontrib><creatorcontrib>Sloan, John H</creatorcontrib><creatorcontrib>Konrad, Robert J</creatorcontrib><creatorcontrib>Mitlak, Bruce H</creatorcontrib><creatorcontrib>Sipos, Adrien A</creatorcontrib><title>The Effect of Discontinuing Treatment With Blosozumab: Follow‐up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density</title><title>Journal of bone and mineral research</title><addtitle>J Bone Miner Res</addtitle><description>ABSTRACT
Administration of blosozumab, a humanized monoclonal antibody that binds sclerostin, increases bone formation and bone mineral density (BMD) in postmenopausal women with low BMD. To evaluate the effect of discontinuing blosozumab, we studied women enrolled in a 1‐year randomized, placebo‐controlled phase 2 trial for an additional year after they completed treatment. Of the 120 women initially enrolled in the study, 106 women completed treatment and continued into follow‐up; 88 women completed 1 year of follow‐up. At the beginning of follow‐up, groups remained balanced for age, race, and body mass index, but lumbar spine and total hip BMD were increased in prior blosozumab groups, reflecting an anabolic treatment effect. At the end of follow‐up, 1 year after discontinuing treatment, lumbar spine BMD remained significantly greater than placebo in women initially treated with blosozumab 270 mg every 2 weeks (Q2W) and blosozumab 180 mg Q2W (6.9% and 3.6% above baseline, respectively). Total hip BMD also declined after discontinuation of treatment but at 1 year after treatment remained significantly greater than placebo in women initially treated with blosozumab 270 mg Q2W and blosozumab 180 mg Q2W (3.9% and 2.6% above baseline, respectively). During follow‐up, median serum P1NP was not consistently different between the prior blosozumab groups and placebo. A similar pattern was apparent for median serum C‐terminal telopeptide of type 1 collagen (CTx) levels, with more variability. Mean serum total sclerostin concentration increased with blosozumab, indicating target engagement, and declined to baseline after discontinuation. There were no adverse events considered related to prior treatment with blosozumab. Anti‐drug antibodies generally declined in patients who had detectable levels during prior treatment. These findings support the continued study of blosozumab as an anabolic therapy for treatment of osteoporosis. © 2015 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).</description><subject>Aged</subject><subject>ANABOLICS</subject><subject>Antibodies, Monoclonal - chemistry</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized - blood</subject><subject>BLOSOZUMAB</subject><subject>Body mass index</subject><subject>Bone Density</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - blood</subject><subject>Bone growth</subject><subject>Bone mineral density</subject><subject>Bone Morphogenetic Proteins - blood</subject><subject>Bone Morphogenetic Proteins - immunology</subject><subject>Bone Resorption</subject><subject>Clinical trials</subject><subject>Collagen</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>DXA</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Genetic Markers - immunology</subject><subject>Hip</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Osteogenesis</subject><subject>OSTEOPOROSIS</subject><subject>Osteoporosis, Postmenopausal - drug therapy</subject><subject>Post-menopause</subject><subject>Postmenopause</subject><subject>SCLEROSTIN ANTIBODY</subject><subject>SOST protein</subject><subject>Spine (lumbar)</subject><subject>Steroids - chemistry</subject><subject>Time Factors</subject><issn>0884-0431</issn><issn>1523-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNqNks9uFCEYwInR2LV68AUMiZf2MC3_BgZv7vafZhubzZoeJ8zAuGwYWIeZbLYnH8G38L36JGXc6sFE4wEI8OP3wccHwGuMTjBC5HRdtd0JYYV8AiY4JzRjvMBPwQQVBcsQo_gAvIhxjRDiOefPwQHJBRIc4wn4sVwZeN40pu5haOCZjXXwvfWD9V_gsjOqb43v4a3tV3DqQgx3Q6uqd_AiOBe299--Dxu4MHFwfRzPK3izUtFAAhfK69DaO6PhzFlva-WSz6beengT4ugNGzXEtHIb0mQfYx62cBq8gdfWmy7tnRkfbb97CZ41ykXz6nE8BJ8vzpezq2z-6fLD7P08qxmTMsNSCMGZZFgUGGmNZCERY3mhGyFMLojOuZYGNUjTqpJVhXNe6WrMEU6Za-ghONp7N134OpjYl21KiXFOeROGWGJBSGoc8_9AUc4EJ5Qm9O0f6DoMnU8PKQnFVOLxnv-ikovRnFM-hj3eU3UXYuxMU24626puV2JUjuVQjuVQjuWQ2DePxqFqjf5N_vr_BJzuga11Zvd3U_lxer34qXwA0XO-sg</recordid><startdate>201509</startdate><enddate>201509</enddate><creator>Recknor, Christopher P</creator><creator>Recker, Robert R</creator><creator>Benson, Charles T</creator><creator>Robins, Deborah A</creator><creator>Chiang, Alan Y</creator><creator>Alam, Jahangir</creator><creator>Hu, Leijun</creator><creator>Matsumoto, Toshio</creator><creator>Sowa, Hideaki</creator><creator>Sloan, John H</creator><creator>Konrad, Robert J</creator><creator>Mitlak, Bruce H</creator><creator>Sipos, Adrien A</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7TS</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201509</creationdate><title>The Effect of Discontinuing Treatment With Blosozumab: Follow‐up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density</title><author>Recknor, Christopher P ; Recker, Robert R ; Benson, Charles T ; Robins, Deborah A ; Chiang, Alan Y ; Alam, Jahangir ; Hu, Leijun ; Matsumoto, Toshio ; Sowa, Hideaki ; Sloan, John H ; Konrad, Robert J ; Mitlak, Bruce H ; Sipos, Adrien A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4499-19777649417810dd098904458df77e572d56d9e0f0d3bb9bb156bdb04311152f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Aged</topic><topic>ANABOLICS</topic><topic>Antibodies, Monoclonal - chemistry</topic><topic>Antibodies, Monoclonal, Humanized - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized - blood</topic><topic>BLOSOZUMAB</topic><topic>Body mass index</topic><topic>Bone Density</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - blood</topic><topic>Bone growth</topic><topic>Bone mineral density</topic><topic>Bone Morphogenetic Proteins - blood</topic><topic>Bone Morphogenetic Proteins - immunology</topic><topic>Bone Resorption</topic><topic>Clinical trials</topic><topic>Collagen</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>DXA</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Genetic Markers - immunology</topic><topic>Hip</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Osteogenesis</topic><topic>OSTEOPOROSIS</topic><topic>Osteoporosis, Postmenopausal - drug therapy</topic><topic>Post-menopause</topic><topic>Postmenopause</topic><topic>SCLEROSTIN ANTIBODY</topic><topic>SOST protein</topic><topic>Spine (lumbar)</topic><topic>Steroids - chemistry</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Recknor, Christopher P</creatorcontrib><creatorcontrib>Recker, Robert R</creatorcontrib><creatorcontrib>Benson, Charles T</creatorcontrib><creatorcontrib>Robins, Deborah A</creatorcontrib><creatorcontrib>Chiang, Alan Y</creatorcontrib><creatorcontrib>Alam, Jahangir</creatorcontrib><creatorcontrib>Hu, Leijun</creatorcontrib><creatorcontrib>Matsumoto, Toshio</creatorcontrib><creatorcontrib>Sowa, Hideaki</creatorcontrib><creatorcontrib>Sloan, John H</creatorcontrib><creatorcontrib>Konrad, Robert J</creatorcontrib><creatorcontrib>Mitlak, Bruce H</creatorcontrib><creatorcontrib>Sipos, Adrien A</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Physical Education Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of bone and mineral research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Recknor, Christopher P</au><au>Recker, Robert R</au><au>Benson, Charles T</au><au>Robins, Deborah A</au><au>Chiang, Alan Y</au><au>Alam, Jahangir</au><au>Hu, Leijun</au><au>Matsumoto, Toshio</au><au>Sowa, Hideaki</au><au>Sloan, John H</au><au>Konrad, Robert J</au><au>Mitlak, Bruce H</au><au>Sipos, Adrien A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Effect of Discontinuing Treatment With Blosozumab: Follow‐up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density</atitle><jtitle>Journal of bone and mineral research</jtitle><addtitle>J Bone Miner Res</addtitle><date>2015-09</date><risdate>2015</risdate><volume>30</volume><issue>9</issue><spage>1717</spage><epage>1725</epage><pages>1717-1725</pages><issn>0884-0431</issn><eissn>1523-4681</eissn><coden>JBMREJ</coden><abstract>ABSTRACT
Administration of blosozumab, a humanized monoclonal antibody that binds sclerostin, increases bone formation and bone mineral density (BMD) in postmenopausal women with low BMD. To evaluate the effect of discontinuing blosozumab, we studied women enrolled in a 1‐year randomized, placebo‐controlled phase 2 trial for an additional year after they completed treatment. Of the 120 women initially enrolled in the study, 106 women completed treatment and continued into follow‐up; 88 women completed 1 year of follow‐up. At the beginning of follow‐up, groups remained balanced for age, race, and body mass index, but lumbar spine and total hip BMD were increased in prior blosozumab groups, reflecting an anabolic treatment effect. At the end of follow‐up, 1 year after discontinuing treatment, lumbar spine BMD remained significantly greater than placebo in women initially treated with blosozumab 270 mg every 2 weeks (Q2W) and blosozumab 180 mg Q2W (6.9% and 3.6% above baseline, respectively). Total hip BMD also declined after discontinuation of treatment but at 1 year after treatment remained significantly greater than placebo in women initially treated with blosozumab 270 mg Q2W and blosozumab 180 mg Q2W (3.9% and 2.6% above baseline, respectively). During follow‐up, median serum P1NP was not consistently different between the prior blosozumab groups and placebo. A similar pattern was apparent for median serum C‐terminal telopeptide of type 1 collagen (CTx) levels, with more variability. Mean serum total sclerostin concentration increased with blosozumab, indicating target engagement, and declined to baseline after discontinuation. There were no adverse events considered related to prior treatment with blosozumab. Anti‐drug antibodies generally declined in patients who had detectable levels during prior treatment. These findings support the continued study of blosozumab as an anabolic therapy for treatment of osteoporosis. © 2015 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>25707611</pmid><doi>10.1002/jbmr.2489</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Aged ANABOLICS Antibodies, Monoclonal - chemistry Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - blood BLOSOZUMAB Body mass index Bone Density Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - blood Bone growth Bone mineral density Bone Morphogenetic Proteins - blood Bone Morphogenetic Proteins - immunology Bone Resorption Clinical trials Collagen Double-Blind Method Drug Administration Schedule DXA Female Follow-Up Studies Genetic Markers - immunology Hip Humans Middle Aged Monoclonal antibodies Osteogenesis OSTEOPOROSIS Osteoporosis, Postmenopausal - drug therapy Post-menopause Postmenopause SCLEROSTIN ANTIBODY SOST protein Spine (lumbar) Steroids - chemistry Time Factors |
title | The Effect of Discontinuing Treatment With Blosozumab: Follow‐up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density |
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