NCT01968850: BATARI

Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Completed Phase 2 Last updated 19 April 2018

What this trial tests

Phase 2 trial testing alendronate/vitamin D in HIV in 30 participants. Completed in 19 March 2018.

Timeline

23 April 2014

Primary endpoint
19 March 2018

19 March 2018

Quick facts

Lead sponsor	Unity Health Toronto
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	30
Start date	23 April 2014
Primary completion	19 March 2018
Estimated completion	19 March 2018
Sites	2 locations across Canada

Drugs / interventions tested

• alendronate/vitamin D — full drug profile →

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Unity Health Toronto — full company profile →

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adverse bone health among children and adolescents growing up with HIV.
   Sudjaritruk T, Puthanakit T. · · 2015 · cited 7× · PMID 27482407 · DOI 10.1016/s2055-6640(20)30506-9