{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T14:58:21Z","timestamp":1780498701381,"version":"3.54.1"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T00:00:00Z","timestamp":1569888000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Human Development","award":["UM1AI068632"],"award-info":[{"award-number":["UM1AI068632"]}]},{"name":"Human Development","award":["UM1AI068616"],"award-info":[{"award-number":["UM1AI068616"]}]},{"name":"Human Development","award":["UM1AI106716"],"award-info":[{"award-number":["UM1AI106716"]}]},{"name":"Human Development","award":["HHSN275201800001I"],"award-info":[{"award-number":["HHSN275201800001I"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,8,22]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Children and adolescents with perinatal human immunodeficiency virus (HIV) infection and with low bone mineral density (BMD) may be at higher risk of osteoporosis and fractures in later life than their uninfected peers. Bisphosphonate therapy has been shown to reduce fractures in adults with osteoporosis, but has not been formally studied in youths living with HIV.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Fifty-two children and adolescents (aged 11\u201324 years) perinatally infected with HIV with low lumbar spine (LS) BMD (Z score &amp;lt; \u22121.5) were randomized to receive once-weekly alendronate or placebo in a double-blind cross-over study designed to assess the safety and efficacy of 48 and 96 weeks of alendronate in the United States and Brazil. All participants received daily calcium carbonate and vitamin D supplementation and were asked to engage in regular weight-bearing exercise. Safety and efficacy are summarized for the initial 48 weeks of the trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Grade 3 or higher abnormal laboratory values, signs, or symptoms developed in 5 of 32 (16%) participants on alendronate and 2 of 18 (11%) on placebo (P &amp;gt; .99). No cases of jaw osteonecrosis, atrial fibrillation, or nonhealing fractures were reported. Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate (20% [14%\u201325%]) than placebo (7% [5%\u20139%]) (P &amp;lt; .001). Similar improvements were seen for whole body BMD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In this small study in children and adolescents perinatally infected with HIV with low LS BMD, 48 weeks of alendronate was well-tolerated, showed no safety concerns, and significantly improved LS and whole body BMD compared to participants on vitamin D\/calcium supplementation and exercise alone.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT00921557.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciz957","type":"journal-article","created":{"date-parts":[[2019,9,26]],"date-time":"2019-09-26T11:27:13Z","timestamp":1569497233000},"page":"1281-1288","source":"Crossref","is-referenced-by-count":13,"title":["Alendronate Improves Bone Mineral Density in Children and Adolescents Perinatally Infected With Human Immunodeficiency Virus With Low Bone Mineral Density for Age"],"prefix":"10.1093","volume":"71","author":[{"given":"Denise L","family":"Jacobson","sequence":"first","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane C","family":"Lindsey","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Gordon","sequence":"additional","affiliation":[{"name":"Division of Adolescent\/Young Adult Medicine, Boston Children\u2019s Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohan","family":"Hazra","sequence":"additional","affiliation":[{"name":"Maternal and Pediatric Infectious Diseases Branch, Division of Extramural Research, Department of Health and Human Services, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Spiegel","sequence":"additional","affiliation":[{"name":"Kelly Government Solutions, contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, 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