Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
- Registration Number
- NCT01968850
- Lead Sponsor
- Unity Health Toronto
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 24-week tx of alendronate/vitamin D alendronate/vitamin D Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D Delayed 24-week tx of alendronate/vitamin D alendronate/vitamin D a 24 week delay in initiation of a 24 week course of alendronate/vitamin D
- Primary Outcome Measures
Name Time Method Percentage changes in BMD at a) the lumbar spine and b) proximal femur 48 weeks The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.
- Secondary Outcome Measures
Name Time Method Feasibility 48 weeks The proportion of patients who are eligible and who consent to participate will be calculated, and the timeliness (rate) of enrollment will be described, to further inform the feasibility of a larger randomized controlled trial.
Acceptability 48 weeks Using standardized questions, participants will be asked about the acceptability of the alendronate therapy (including the experience of pill-taking and the weekly schedule)
Adherence 48 weeks Adherence with anti-resorptive therapy will be assessed by pill count and questionnaire.
Bone Biomarkers 48 weeks Two bone biomarkers will be assessed: cross-linked carboxyterminal-telopeptide (CTX) and aminoterminal propeptide of type 1 collagen (P1NP).
Safety/Tolerability 48 weeks As per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Trial Locations
- Locations (2)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada