Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density
|ClinicalTrials.gov Identifier: NCT00102908|
Recruitment Status : Unknown
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was: Active, not recruiting
First Posted : February 7, 2005
Last Update Posted : September 26, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Osteopenia Osteoporosis||Drug: Zoledronate Drug: Zoledronate placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Bisphosphonate Therapy for HIV-Associated Osteopenia|
|Study Start Date :||May 2005|
|Estimated Primary Completion Date :||October 2007|
|Estimated Study Completion Date :||December 2009|
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
- Bone metabolic markers [ Time Frame: Throughout study ]
- Safety outcomes [ Time Frame: Throughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|