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

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