Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density
Bisphosphonates are a type of drug used to prevent and treat bone loss. The purpose of this study is to determine if zoledronate, an investigational bisphosphonate, can improve bone mineral density (BMD) in HIV-infected adults.
Study hypothesis: Zoledronate will reduce bone resorption in HIV-infected persons with osteopenia.
Drug: Zoledronate placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Bisphosphonate Therapy for HIV-Associated Osteopenia|
- Bone metabolic markers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Safety outcomes [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Participants will receive zoledronate at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis
Placebo Comparator: 2
Participants will receive zoledronate placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis
Drug: Zoledronate placebo
Zoledronate placebo infusion
Decreased BMD and bone loss is estimated to affect up to 67.5% of the HIV-infected population. HIV-associated bone loss may be a result of antiretroviral treatment (ART), but can also be caused by the infection itself. To date, treatment for this bone loss has not been established. Before prescribing drugs to treat bone loss, physicians must take into account patients' already demanding ART schedules and potential nonadherence. This study will evaluate the efficacy of a single IV dose of zoledronate, an investigational bisphosphonate, in treating HIV-associated bone loss.
This study will last 1 year. Participants will be randomly assigned to receive zoledronate or placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis. There will be 7 study visits: at screening, study entry, Week 2, and Months 3, 6, 9, and 12. Blood collection will occur at all visits. Medical history, a physical exam, a dual-energy x-ray absorptiometry (DEXA) scan to measure bone density, and a nutrition evaluation will occur at selected visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102908
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92103|
|Principal Investigator:||Jeannie S. Huang, MD, MPH||University of California, San Diego|