The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Once-Weekly Alendronate in HIV-Infected Subjects With Decreased Bone Mineral Density Receiving Calcium and Vitamin D
2 other identifiers
interventional
80
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2003
CompletedFirst Posted
Study publicly available on registry
May 23, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedAugust 7, 2009
August 1, 2009
May 22, 2003
August 6, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 infection
- 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
You may not qualify if:
- Men with untreated low total serum testosterone levels within 60 days prior to study entry, or men with plans to initiate testosterone replacement during the study
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama-Birmingham
Birmingham, Alabama, 35294-2050, United States
UCLA School of Medicine
Los Angeles, California, 90095-1793, United States
University of California, San Diego
San Diego, California, 92103, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
Stanford Univ
Stanford, California, 94305-5107, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Northwestern University
Chicago, Illinois, 60611-5012, United States
Cook County Hospital Core Center
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202-5250, United States
Methodist Hosp of Indiana
Indianapolis, Indiana, 46202-5250, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392, United States
Nebraska Health System
Omaha, Nebraska, 68198-5130, United States
Chelsea Clinic
New York, New York, 10011, United States
NYU/Bellevue
New York, New York, 10016-6481, United States
AIDS Community Health Center
Rochester, New York, 14642-0001, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642-0001, United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106-5083, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hosp
Providence, Rhode Island, 02906, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906, United States
The Miriam Hosp
Providence, Rhode Island, 02906, United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203, United States
Univ of Texas, Galveston
Galveston, Texas, 77555-0435, United States
University of Washington (Seattle)
Seattle, Washington, 98104, United States
Related Publications (6)
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.
PMID: 10770534BACKGROUNDReid 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.
PMID: 9669144BACKGROUNDOrwoll 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.
PMID: 10979796BACKGROUNDSchnitzer 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.
PMID: 10746426BACKGROUNDMondy 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.
PMID: 12652379BACKGROUNDMcComsey 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.
PMID: 18025884DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Grace McComsey, MD
Division of Infectious Diseases, Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
May 22, 2003
First Posted
May 23, 2003
Study Completion
September 1, 2006
Last Updated
August 7, 2009
Record last verified: 2009-08