Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• HIV-infected

• On stable antiretroviral regimen for at least 3 months

• Able to walk

• Lumbar spine or total hip BMD T-score at least 1.5 SD and no more than 3.5 SD below the mean BMD

• No prevalent fractures at entry OR 1 prevalent vertebral fracture that has been asymptomatic during the last 2 years prior to study entry

• HIV viral load of less than 5000 copies/ml within the 2 months prior to study entry

• CD4 count of more than 100 cells/mm3 within the 2 months prior to study entry

• Willing to use acceptable forms of contraception during the study period and for 6 months after study completion. Participants who are female and postmenopausal will be required to take hormone replacement therapy during this study.

Exclusion Criteria:

• Prior treatment with bisphosphonates or fluoride

• Use of supraphysiologic systemic estrogen/androgen therapy or corticosteroid therapy within the 3 months prior to study entry. Participants who have taken hormone replacement therapy are not excluded.

• Significant liver or kidney disease

• Hemoglobin less than 8 g/dL

• Serum calcium less than 8 mg/dL

• Laboratory evidence of low levels of estrogens or androgens

• Laboratory evidence of overactive parathyroid glands

• History of thyroid, parathyroid, or other endocrinologic disorder known to affect bone

• Current use of any therapy known to affect bone

• Current or history of cancer or chemotherapy

• Current or history of radiotherapy to the jaw

• Current osteomyelitis of the jaw or ongoing dental infection

• Recent tooth extraction or major dental procedure within 3 weeks of study entry

• Pregnancy or breastfeeding