{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T08:00:17Z","timestamp":1793174417448,"version":"4.5.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T00:00:00Z","timestamp":1708560000000},"content-version":"vor","delay-in-days":144,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T00:00:00Z","timestamp":1690416000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015831","name":"Radius Health, Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015831","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100015831","name":"Radius Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015831","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["asbmr.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,10,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Anabolic therapies, recommended for patients at very high fracture risk, are administered subcutaneously (SC). The objective of this study was to evaluate the efficacy and safety of the abaloparatide microstructured transdermal system (abaloparatide-sMTS) as an alternative to the SC formulation. This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N\u2009=\u2009511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12\u2009months. The primary comparison between treatment groups was the percentage change in lumbar spine bone mineral density (BMD) at 12\u2009months, with a noninferiority margin of 2.0%. Secondary endpoints included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence. At 12\u2009months, percentage increase from baseline in lumbar spine BMD was 7.14% (SE: 0.46%) for abaloparatide-sMTS and 10.86% (SE: 0.48%) for abaloparatide-SC (treatment difference: \u22123.72% [95% confidence interval: \u22125.01%, \u22122.43%]). Percentage change in total hip BMD was 1.97% for abaloparatide-sMTS and 3.70% for abaloparatide-SC. Median changes from baseline at 12\u2009months in serum procollagen type I N-terminal propeptide (s-PINP) were 52.6% for abaloparatide-sMTS and 74.5% for abaloparatide-SC. Administration site reactions were the most frequently reported adverse events (abaloparatide-sMTS, 94.4%; abaloparatide-SC, 70.5%). Incidence of serious adverse events was similar between groups. Mild or moderate skin reactions occurred with abaloparatide-sMTS with no identifiable risk factors for sensitization reactions. Few new clinical fractures occurred in either group. Noninferiority of abaloparatide-sMTS to abaloparatide-SC for percentage change in spine BMD at 12\u2009months was not demonstrated; however, clinically meaningful increases from baseline in lumbar spine and total hip BMD were observed in both treatment groups. \u00a9 2023 Radius Health, Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).<\/jats:p>\n                  <jats:p>Abstract<\/jats:p>\n                  <jats:p>In postmenopausal women with osteoporosis, the least-squares mean percentage change (SE) from baseline in lumbar spine BMD at 12\u2009months was 7.14% (0.46%) for daily transdermal abaloparatide and 10.86% (0.48%) for daily SC abaloparatide, with a treatment difference of \u22123.72% (95% CI: \u22125.01%, \u22122.43%). Clinically meaningful changes were also seen in total hip BMD.<\/jats:p>","DOI":"10.1002\/jbmr.4877","type":"journal-article","created":{"date-parts":[[2023,7,7]],"date-time":"2023-07-07T08:36:46Z","timestamp":1688719006000},"page":"1404-1414","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study"],"prefix":"10.1093","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2026-9587","authenticated-orcid":false,"given":"E. Michael","family":"Lewiecki","sequence":"first","affiliation":[{"name":"New Mexico Clinical Research & Osteoporosis Center Albuquerque NM USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Czerwinski","sequence":"additional","affiliation":[{"name":"Krakow Medical Center Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Recknor","sequence":"additional","affiliation":[{"name":"United Osteoporosis Centers Gainesville GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Strzelecka","sequence":"additional","affiliation":[{"name":"SOMED \u0141\u00f3d\u017a Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Valenzuela","sequence":"additional","affiliation":[{"name":"Integral Rheumatology & Immunology Specialist (IRIS) Plantation FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Carteret Medical Group Morehead City NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Silverman","sequence":"additional","affiliation":[{"name":"Osteoporosis Medical Center Beverly Hills CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose","family":"Cardona","sequence":"additional","affiliation":[{"name":"Indago Research & Health Center, Inc. Hialeah FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan M.","family":"Nattrass","sequence":"additional","affiliation":[{"name":"Puget Sound Osteoporosis Center Burien WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9905-461X","authenticated-orcid":false,"given":"Neil","family":"Binkley","sequence":"additional","affiliation":[{"name":"University of Wisconsin Osteoporosis Clinical Research Program Madison WI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Annett","sequence":"additional","affiliation":[{"name":"Radius Health, Inc. Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leny","family":"Pearman","sequence":"additional","affiliation":[{"name":"Radius Health, Inc. Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7050-0703","authenticated-orcid":false,"given":"Bruce","family":"Mitlak","sequence":"additional","affiliation":[{"name":"Radius Health, Inc. 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