{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T11:17:13Z","timestamp":1784546233099,"version":"3.55.0"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2020,12,1]],"date-time":"2020-12-01T00:00:00Z","timestamp":1606780800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"},{"start":{"date-parts":[[2021,4,27]],"date-time":"2021-04-27T00:00:00Z","timestamp":1619481600000},"content-version":"vor","delay-in-days":147,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA."}],"content-domain":{"domain":["asbmr.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,12,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:p>We prospectively assessed, with predefined criteria, the location and rates of all femur fractures (hip, subtrochanteric\/femoral shaft [ST\/FS], including atypical [AFF] and distal fractures) in women at increased fracture risk during treatment with the cathepsin K inhibitor, odanacatib (ODN), or placebo over 5\u2009years in the Long-Term ODN Fracture Trial (LOFT and LOFT Extension [NCT00529373, EudraCT 2007-002693-66]). ODN was an investigational antiresorptive agent previously in development as an osteoporosis treatment that, unlike bisphosphonates, reduces bone formation only transiently. Women aged \u226565\u2009years with a bone mineral density (BMD) T-score\u2009\u2264\u22122.5 at the total hip (TH) or femoral neck (FN) or with a radiographic vertebral fracture and T-scores \u2264\u22121.5 at the TH or FN were randomized (1:1) to receive ODN 50\u2009mg\/week or placebo. All patients received vitamin D3 (5600\u2009IU\/week) and calcium (total 1200\u2009mg\/d); the analysis included 16,071 women. Rates of all adjudicated low-energy femoral fractures were 0.38 versus 0.58\/100 patient-years for ODN and placebo, respectively (hazard ratio [HR] =\u20090.65; 95% confidence interval [CI] 0.51\u20130.82; nominal p\u2009&amp;lt;\u2009.001), and for low-energy hip fractures were 0.29 versus 0.56\/100 patient-years, respectively (HR\u00a0=\u00a00.52; 95% CI 0.40\u20130.67; p\u2009&amp;lt;\u2009.001). The cumulative incidence of combined hip and ST\/FS or hip fractures alone in the ODN group was consistently lower than in the placebo group (1.93% versus 3.11% for combined fractures and 1.53% versus 3.03% for hip fractures at 5\u2009years, respectively). However, low-energy ST\/FS fractures were more frequent in ODN-treated women than in placebo-treated women (24 versus 6, respectively). Among these, 12 fractures were adjudicated as AFF in 10 patients treated with ODN (0.03\/100 patient-years) compared with none in the 6 placebo-treated women (estimated difference 0.03; 95% CI 0.02\u20130.06). These results provide insight into possible pathogeneses of AFF, suggesting that the current criteria for diagnosing these fractures may need to be reconsidered. \u00a9 2021 American Society for Bone and Mineral Research (ASBMR)..<\/jats:p>","DOI":"10.1002\/jbmr.4284","type":"journal-article","created":{"date-parts":[[2021,3,16]],"date-time":"2021-03-16T19:40:03Z","timestamp":1615923603000},"page":"1225-1234","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Incidence of Hip and Subtrochanteric\/Femoral Shaft Fractures in Postmenopausal Women With Osteoporosis in the Phase 3 Long-Term Odanacatib Fracture Trial"],"prefix":"10.1093","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2243-6940","authenticated-orcid":false,"given":"Socrates","family":"Papapoulos","sequence":"first","affiliation":[{"name":"Leiden University Medical Center Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Bone","sequence":"additional","affiliation":[{"name":"Michigan Bone & Mineral Clinic Detroit MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4554-6616","authenticated-orcid":false,"given":"Felicia","family":"Cosman","sequence":"additional","affiliation":[{"name":"Columbia University New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2262-4039","authenticated-orcid":false,"given":"David W","family":"Dempster","sequence":"additional","affiliation":[{"name":"Columbia University New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7827-0778","authenticated-orcid":false,"given":"Michael R","family":"McClung","sequence":"additional","affiliation":[{"name":"Mary MacKillop Institute for Health Research, Australian Catholic University Melbourne Australia"},{"name":"Oregon Osteoporosis Center Portland OR USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshitaka","family":"Nakamura","sequence":"additional","affiliation":[{"name":"University of Occupational and Environmental Health Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Fernando Molina","family":"Restrepo","sequence":"additional","affiliation":[{"name":"Reumalab Medell\u00edn Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7027-7414","authenticated-orcid":false,"given":"Mary L","family":"Bouxsein","sequence":"additional","affiliation":[{"name":"Center for Advanced Orthopedic Studies, Beth Israel Deaconess Medical Center, and Department of Orthopedic Surgery Harvard Medical School Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dosinda","family":"Cohn","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. Kenilworth NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"de Papp","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. Kenilworth NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachid","family":"Massaad","sequence":"additional","affiliation":[{"name":"MSD Europe Inc. Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur","family":"Santora","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. Kenilworth NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,3,16]]},"reference":[{"issue":"11","key":"2024012713474545500_jbmr4284-bib-0001","doi-asserted-by":"crossref","first-page":"2267","DOI":"10.1002\/jbmr.253","article-title":"Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research","volume":"25","author":"Shane","year":"2010","journal-title":"J Bone Miner Res."},{"issue":"1","key":"2024012713474545500_jbmr4284-bib-0002","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1002\/jbmr.1998","article-title":"Atypical subtrochanteric and diaphyseal femoral fractures: second report of a task force of the American Society for Bone and Mineral Research","volume":"29","author":"Shane","year":"2014","journal-title":"J Bone Miner 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