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Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial — BATARI  

HIV Clinical Trial

Official title:
Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Clinical Trial Summary

This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms:

1. no bone anti-resorptive therapy (standard of care)

2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;

3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D

Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary objective will involve calculation of σ and ρ using all data; δ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01968850
Study type Interventional
Source St. Michael's Hospital, Toronto
Contact
Status Completed
Phase Phase 2
Start date April 23, 2014
Completion date March 19, 2018
View Details
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