The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00061256

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

80

Expected to finish

2006-09-01

Last updated by the study team

2009-08-07

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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