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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Alendronate; Calcium; Calcium Carbonate; Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

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