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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00061256
• Date of registration: 22/05/2003
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
• Scientific 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
• Date of first enrolment: April 2004
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00061256
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Grace McComsey, MD
• Affiliation: Division of Infectious Diseases, Case Western Reserve University

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Alendronate

Drug: Calcium carbonate

Drug: Vitamin D

Secondary ID(s)

ACTG A5163

DAIDS-ES ID 10089

Source(s) of Monetary Support

Please refer to primary and secondary sponsors