The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Alendronate (Drug); Calcium carbonate (Drug); Vitamin D (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Grace McComsey, MD, Study Chair, Affiliation: Division of Infectious Diseases, Case Western Reserve University
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 25 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Locations and Contacts
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, District of Columbia 20007, United States
Cook County Hospital Core Center, Chicago, Illinois 60612, United States
Northwestern University, Chicago, Illinois 60611-5012, 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
Additional Information
Click here for more information about alendronate. Click here for more information about calcium carbonate. Click here for more information about vitamin D. Haga clic aquí para ver información sobre este ensayo clínico en español.
Related publications: 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. 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. Review. 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. 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.
Last updated: August 6, 2009
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