NCT01968850

Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	alendronate/vitamin D	once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.

Timeline

• Start date: 2014-04-23
• Primary completion: 2018-03-19
• Completion: 2018-03-19
• First posted: 2013-10-24
• Last updated: 2018-04-19

Locations

2 sites across 1 country: Canada