Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents
Completed · Phase 2 · Has a placebo group
Conditions studied: HIV Infection
In brief
HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study was to compare changes from pre-treatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in HIV-infected children and adolescents.
Key facts
- Study ID
- NCT00921557
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 52
- Starts
- 2009-11-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2021-11-05
Who can join
Age: 11 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
Where it is running
- David Geffen School of Medicine at UCLA NICHD CRS — Los Angeles, California, United States
- Pediatric Perinatal HIV Clinical Trials Unit CRS — Miami, Florida, United States
- USF - Tampa NICHD CRS — Tampa, Florida, United States
- Lurie Children's Hospital of Chicago (LCH) CRS — Chicago, Illinois, United States
- Johns Hopkins Univ. Baltimore NICHD CRS — Baltimore, Maryland, United States
- WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
- St. Jude Children's Research Hospital CRS — Memphis, Tennessee, United States
- SOM Federal University Minas Gerais Brazil NICHD CRS — Belo Horizonte, Minas Gerais, Brazil
- Univ. of Sao Paulo Brazil NICHD CRS — São Paulo, Brazil
- San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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