Status:
UNKNOWN
Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Osteopenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 (B...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00102908
Start Date
May 1 2005
End Date
December 1 2009
Last Update
September 26 2008
Active Locations (1)
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1
University of California, San Diego
San Diego, California, United States, 92103