Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Unity Health Toronto

Status and phase: Completed; Phase 2

Conditions: HIV

Treatments: Drug: alendronate/vitamin D

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01968850

CTNPT 021

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented HIV-1 infection
• Adult (aged >18 years or as per local guidelines)
• Premenopausal, if female
• Antiretroviral-naïve
• Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formulated as Stribild®)
• Low (<10%) ten-year fracture risk as assessed by the FRAX score validated for Canadian populations

Exclusion criteria

• Presence of established osteoporosis at baseline as determined by BMD measurement
• Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.)
• Inability to communicate in English
• Creatinine clearance <35 mL/min (using Cockcroft-Gault formula)
• Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation
• Hypocalcemia
• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
• Inability to stand or sit upright for at least 30 minutes
• Pregnancy, active plans to become pregnant, or lactation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

no bone anti-resorptive therapy

No Intervention group

Description:

(standard of care)

24-week tx of alendronate/vitamin D

Experimental group

Description:

Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D

Treatment:

Drug: alendronate/vitamin D

Delayed 24-week tx of alendronate/vitamin D

Experimental group

Description:

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

Treatment:

Drug: alendronate/vitamin D