The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
NCT ID: NCT00061256
Last Updated: 2009-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2006-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Alendronate
Calcium carbonate
Vitamin D
Eligibility Criteria
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Inclusion Criteria
* Lumbar spine DEXA scan confirming decreased BMD within 90 days prior to study entry
* CD4 cell count 100 cells/mm3 or more within 30 days prior to study entry
* Stable antiretroviral regimen for at least 12 weeks prior to study entry
* No plans to alter antiretroviral therapy or to initiate structured/strategic treatment interruptions
* No plans to significantly alter exercise habits or diet for the duration of the study
* Documentation of two consecutive measurements of viral load of 5000 copies/ml or less within 90 days prior to study entry, with at least one of the two values obtained within 30 days prior to study entry
* Willing to use acceptable methods of contraception
* For women with the absence of menses for at least 6 months, serum prolactin level in the normal range within 60 days prior to study entry
* For women taking estrogen therapy, stable estrogen regimen for at least 24 weeks prior to study entry, with no plan to change estrogen dose for the duration of the study
* Serum calcium between 8 mg/dl and 11 mg/dl within 30 days prior to study entry
Exclusion Criteria
* Cannot receive vitamin D or calcium supplements
* Daily vitamin or dietary supplements that include 10,000 IU or greater of vitamin A within 90 days prior to study entry
* Hyperparathyroidism, vitamin D deficiency, or oral thrush within 60 days prior to study entry
* Any current or past conditions that predispose to disorders involving the esophagus. Participants with a history of mild or controlled reflux may be enrolled.
* Esophagitis within 6 months prior to study entry
* Pregnant or breastfeeding
* Paget's disease
* Spinal fracture (thoracic or lumbar spine) within 60 days prior to study entry
* Atraumatic bone fracture at any time since 18 years of age
* Spinal fracture at any time in the past
* Inability to stand or sit upright for at least 30 minutes
* Use of systemic glucocorticoids for a cumulative duration of longer than 4 weeks within 6 months immediately prior to study entry
* Use of medications for treatment of osteoporosis within 12 months prior to study entry
* Allergy/hypersensitivity to any component of alendronate, the components of the tablet, or bisphosphonate compounds
* Active drug or alcohol dependence which, in the opinion of the investigator, would interfere with adherence to study requirements or would endanger the patient's health while on study
* Hospitalization for alcohol-related liver disease at any time in the past
* Current use of systemic cytotoxic chemotherapy
* Acute illness within 30 days prior to study entry which, in the opinion of the investigator, would interfere with participation in the study
* History of hepatitis C virus infection
* For participants using anabolic steroids, use of steroids for less than 6 months prior to entry or plans to change current regimen during the course of the study; if a steroid regimen has been discontinued, it must have been discontinued at least 6 months prior to entry
25 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Grace McComsey, MD
Role: STUDY_CHAIR
Division of Infectious Diseases, Case Western Reserve University
Locations
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University of Alabama-Birmingham
Birmingham, Alabama, United States
UCLA School of Medicine
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
San Francisco General Hospital
San Francisco, California, United States
Stanford Univ
Stanford, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Cook County Hospital Core Center
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana
Indianapolis, Indiana, United States
Wishard Hosp
Indianapolis, Indiana, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Nebraska Health System
Omaha, Nebraska, United States
Chelsea Clinic
New York, New York, United States
NYU/Bellevue
New York, New York, United States
AIDS Community Health Center
Rochester, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States
Rhode Island Hosp
Providence, Rhode Island, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, United States
The Miriam Hosp
Providence, Rhode Island, United States
Comprehensive Care Clinic
Nashville, Tennessee, United States
Univ of Texas, Galveston
Galveston, Texas, United States
University of Washington (Seattle)
Seattle, Washington, United States
Countries
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References
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Tebas P, Powderly WG, Claxton S, Marin D, Tantisiriwat W, Teitelbaum SL, Yarasheski KE. Accelerated bone mineral loss in HIV-infected patients receiving potent antiretroviral therapy. AIDS. 2000 Mar 10;14(4):F63-7. doi: 10.1097/00002030-200003100-00005.
Reid IR. The roles of calcium and vitamin D in the prevention of osteoporosis. Endocrinol Metab Clin North Am. 1998 Jun;27(2):389-98. doi: 10.1016/s0889-8529(05)70011-6.
Orwoll E, Ettinger M, Weiss S, Miller P, Kendler D, Graham J, Adami S, Weber K, Lorenc R, Pietschmann P, Vandormael K, Lombardi A. Alendronate for the treatment of osteoporosis in men. N Engl J Med. 2000 Aug 31;343(9):604-10. doi: 10.1056/NEJM200008313430902.
Schnitzer T, Bone HG, Crepaldi G, Adami S, McClung M, Kiel D, Felsenberg D, Recker RR, Tonino RP, Roux C, Pinchera A, Foldes AJ, Greenspan SL, Levine MA, Emkey R, Santora AC 2nd, Kaur A, Thompson DE, Yates J, Orloff JJ. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano). 2000 Feb;12(1):1-12.
Mondy K, Tebas P. Emerging bone problems in patients infected with human immunodeficiency virus. Clin Infect Dis. 2003 Apr 1;36(Suppl 2):S101-5. doi: 10.1086/367566.
McComsey GA, Kendall MA, Tebas P, Swindells S, Hogg E, Alston-Smith B, Suckow C, Gopalakrishnan G, Benson C, Wohl DA. Alendronate with calcium and vitamin D supplementation is safe and effective for the treatment of decreased bone mineral density in HIV. AIDS. 2007 Nov 30;21(18):2473-82. doi: 10.1097/QAD.0b013e3282ef961d.
Related Links
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Click here for more information about alendronate.
Click here for more information about calcium carbonate.
Other Identifiers
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DAIDS-ES ID 10089
Identifier Type: -
Identifier Source: secondary_id
ACTG A5163
Identifier Type: -
Identifier Source: org_study_id
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