The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00061256
- Brief Summary
Alendronate is a drug that is used to treat osteoporosis. The purpose of this study is to examine whether alendronate in combination with calcium and vitamin D is safe and effective for treating bone loss in people with HIV.
- Detailed Description
Decreased bone mineral density (BMD) has been identified in up to 50% of HIV infected men, with severe osteoporosis in up to 21% of these men. The mechanisms underlying these bone abnormalities remain unclear. Bisphosphonates are potent bone resorption inhibitors and have been shown to be effective in treating osteoporosis. While several bisphosphonates are approved for the treatment of osteoporosis in women, alendronate is the only bisphosphonate approved for treatment in men. This study hypothesizes that alendronate will be able to reverse decreased BMD secondary to inhibition of bone resorption in HIV infected patients treated with potent antiretroviral therapy, and that these patients will be able to tolerate alendronate without any significant toxicities. The study will also examine the efficacy of once-weekly alendronate with daily calcium and vitamin D in both men and women with HIV.
Patients will participate in this study for 48 weeks. Patients will be randomly assigned to receive either alendronate or placebo. All patients will receive calcium and vitamin D. Dual energy x-ray absorptiometry (DEXA) scans will be used to evaluate bone density at each visit. After study entry, patients will have visits at Weeks 2, 12, 24, 36, and 48. During these visits, blood will be drawn and a pregnancy test may be performed. Patients must fast for at least 8 hours prior to the entry visit and for the visits at Weeks 2, 12, 24, and 48.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Stanford Univ
🇺🇸Stanford, California, United States
Chelsea Clinic
🇺🇸New York, New York, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Methodist Hosp of Indiana
🇺🇸Indianapolis, Indiana, United States
Stanley Street Treatment and Resource
🇺🇸Providence, Rhode Island, United States
The Miriam Hosp
🇺🇸Providence, Rhode Island, United States
University of Washington (Seattle)
🇺🇸Seattle, Washington, United States
University of California, San Diego
🇺🇸San Diego, California, United States
AIDS Community Health Center
🇺🇸Rochester, New York, United States
University of Pennsylvania, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Comprehensive Care Clinic
🇺🇸Nashville, Tennessee, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
NYU/Bellevue
🇺🇸New York, New York, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Rhode Island Hosp
🇺🇸Providence, Rhode Island, United States
Univ of Texas, Galveston
🇺🇸Galveston, Texas, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Cook County Hospital Core Center
🇺🇸Chicago, Illinois, United States
Wishard Hosp
🇺🇸Indianapolis, Indiana, United States
Nebraska Health System
🇺🇸Omaha, Nebraska, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States