{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T19:30:48Z","timestamp":1793302248169,"version":"4.5.0"},"reference-count":48,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:00:00Z","timestamp":1721088000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100022502","name":"Mereo BioPharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100022502","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013220","name":"Ultragenyx Pharmaceutical Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013220","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013220","name":"Ultragenyx Pharmaceutical Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013220","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Cambridge NIHR Biomedical Research Centre"},{"name":"FRQS Programme de Bourses de Chercheur"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,9,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Osteogenesis imperfecta (OI) is a rare genetic disorder commonly caused by variants of the type I collagen genes COL1A1 and COL1A2. OI is associated with increased bone fragility, bone deformities, bone pain, and reduced growth. Setrusumab, a neutralizing antibody to sclerostin, increased areal bone mineral density (aBMD) in a 21-week phase 2a dose escalation study. The phase 2b Asteroid (NCT03118570) study evaluated the efficacy and safety of setrusumab in adults. Adults with a clinical diagnosis of OI type I, III, or IV, a pathogenic variant in COL1A1\/A2, and a recent fragility fracture were randomized 1:1:1:1 to receive 2, 8, or 20\u00a0mg\/kg setrusumab doses or placebo by monthly intravenous infusion during a 12-mo treatment period. Participants initially randomized to the placebo group were subsequently reassigned to receive setrusumab 20\u00a0mg\/kg open label. Therefore, only results from the 2, 8, and 20\u00a0mg\/kg double-blind groups are presented herein. The primary endpoint of Asteroid was change in distal radial trabecular volumetric bone mineral density (vBMD) from baseline at month 12, supported by changes in high-resolution peripheral quantitative computed tomography micro-finite element (microFE)-derived bone strength. A total of 110 adults were enrolled with similar baseline characteristics across treatment groups. At 12\u00a0mo, there was a significant increase in mean (SE) failure load in the 20\u00a0mg\/kg group (3.17% [1.26%]) and stiffness in the 8 (3.06% [1.70%]) and 20\u00a0mg\/kg (3.19% [1.29%]) groups from baseline. There were no changes in radial trabecula vBMD (p&amp;gt;05). Gains in failure load and stiffness were similar across OI types. There were no significant differences in annualized fracture rates between doses. Two adults in the 20\u00a0mg\/kg group experienced related serious adverse reactions. Asteroid demonstrated a beneficial effect of setrusumab on estimates of bone strength across the different types of OI and provides the basis for additional phase 3 evaluation.<\/jats:p>","DOI":"10.1093\/jbmr\/zjae112","type":"journal-article","created":{"date-parts":[[2024,7,15]],"date-time":"2024-07-15T17:47:26Z","timestamp":1721065646000},"page":"1215-1228","source":"Crossref","is-referenced-by-count":42,"title":["Setrusumab for the treatment of osteogenesis imperfecta: 12-month results from the phase 2b asteroid study"],"prefix":"10.1093","volume":"39","author":[{"given":"Francis H","family":"Glorieux","sequence":"first","affiliation":[{"name":"Departments of Surgery , Pediatrics and Human Genetics, Shriners Hospitals for Children, , Montreal, Quebec H4A 0A9,","place":["Canada"]},{"name":"McGill University , Pediatrics and Human Genetics, Shriners Hospitals for Children, , Montreal, Quebec H4A 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Reid","family":"Sutton","sequence":"additional","affiliation":[{"name":"Department of Molecular & Human Genetics, Baylor College of Medicine & Texas Children\u2019s Hospital , Houston, TX 77030,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth E S","family":"Poole","sequence":"additional","affiliation":[{"name":"Department of Medicine & Cambridge NIHR Biomedical Research Centre, University of Cambridge , Cambridge CB3 0FA,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9980-9138","authenticated-orcid":false,"given":"Kathryn M","family":"Dahir","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Vanderbilt University Medical Center , Nashville, TN 37232,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric S","family":"Orwoll","sequence":"additional","affiliation":[{"name":"Division of Endocrinology , Diabetes and Clinical Nutrition, School of Medicine, , Portland, OR 97239,","place":["United States"]},{"name":"Oregon Health & Sciences University , Diabetes and Clinical Nutrition, School of Medicine, , Portland, OR 97239,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2907-3580","authenticated-orcid":false,"given":"Bettina M","family":"Willie","sequence":"additional","affiliation":[{"name":"Faculty of Dental Medicine and Oral Health Sciences, McGill University , Montreal H3A 2T5,","place":["Canada"]},{"name":"Shriners Hospitals for Children , Montreal, Quebec H4A 0A9,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Mikolajewicz","sequence":"additional","affiliation":[{"name":"Faculty of Dental Medicine and Oral Health Sciences, McGill University , Montreal H3A 2T5,","place":["Canada"]},{"name":"Shriners Hospitals for Children , Montreal, Quebec H4A 0A9,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9927-3372","authenticated-orcid":false,"given":"Elizabeth","family":"Zimmermann","sequence":"additional","affiliation":[{"name":"Faculty of Dental Medicine and Oral Health Sciences, McGill University , Montreal H3A 2T5,","place":["Canada"]},{"name":"Shriners Hospitals for Children , Montreal, Quebec H4A 0A9,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5638-976X","authenticated-orcid":false,"given":"Seyedmahdi","family":"Hosseinitabatabaei","sequence":"additional","affiliation":[{"name":"Faculty of Dental Medicine and Oral Health Sciences, McGill University , Montreal H3A 2T5,","place":["Canada"]},{"name":"Shriners Hospitals for Children , Montreal, Quebec H4A 0A9,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S","family":"Ominsky","sequence":"additional","affiliation":[{"name":"Ultragenyx Pharmaceutical Inc. , Novato, CA 94949,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Saville","sequence":"additional","affiliation":[{"name":"ICON Plc , Leopardstown, Dublin D 18,","place":["Ireland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Clancy","sequence":"additional","affiliation":[{"name":"Mereo BioPharma , London W16 0QF,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alastair","family":"MacKinnon","sequence":"additional","affiliation":[{"name":"Mereo BioPharma , London W16 0QF,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arun","family":"Mistry","sequence":"additional","affiliation":[{"name":"Mereo BioPharma , London W16 0QF,","place":["United 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