Alendronate Improves Bone Mineral Density in Children and Adolescents Perinatally Infected With Human Immunodeficiency Virus With Low Bone Mineral Density for Age
Open Access
- 1 October 2019
- journal article
- research article
- Published by Oxford University Press (OUP) in Clinical Infectious Diseases
- Vol. 71 (5), 1281-1288
- https://doi.org/10.1093/cid/ciz957
Abstract
Background. 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. Methods. Fifty-two children and adolescents (aged 11-24 years) perinatally infected with HIV with low lumbar spine (LS) BMD (Z score < -1.5) 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. Results. 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 > .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%-25%]) than placebo (7% [5%-9%]) (P < .001). Similar improvements were seen for whole body BMD. Conclusions. 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.Keywords
Funding Information
- National Institute of Allergy and Infectious Diseases
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Human Development (UM1AI068632, UM1AI068616, UM1AI106716, HHSN275201800001I)
This publication has 31 references indexed in Scilit:
- Body fat distribution in perinatally HIV-infected and HIV-exposed but uninfected children in the era of highly active antiretroviral therapy: outcomes from the Pediatric HIV/AIDS Cohort StudyThe American Journal of Clinical Nutrition, 2011
- Dual Energy X-Ray Absorptiometry Body Composition Reference Values from NHANESPLOS ONE, 2009
- Continuous antiretroviral therapy decreases bone mineral densityAIDS, 2009
- Effect of Bimonthly Supplementation With Oral Cholecalciferol on Serum 25-Hydroxyvitamin D Concentrations in HIV-Infected Children and AdolescentsPublished by American Academy of Pediatrics (AAP) ,2009
- Long-term use of bisphosphonates in the treatment of HIV-related bone pain in perinatally infected pediatric patientsAIDS, 2008
- Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIVAIDS, 2007
- The Safety and Efficacy of Tenofovir DF in Combination with Lamivudine and Efavirenz Through 6 Years in Antiretroviral-Naïve HIV-1—Infected PatientsHIV Research & Clinical Practice, 2007
- Osteoporosis and Multiple Fractures in an Antiretroviral-naive, HIV-Positive ChildJournal of Pediatric Endocrinology and Metabolism, 2007
- Two-Year Clinical Trial of Oral Alendronate Versus Intravenous Pamidronate in Children With Osteogenesis ImperfectaJournal of Bone and Mineral Research, 2006
- Alendronate for steroid-induced osteopenia in children with acute lymphoblastic leukaemia or non-Hodgkin’s lymphoma: results of a pilot studyJournal of Oncology Pharmacy Practice, 2005