Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
Information source: St. Michael's Hospital, Toronto
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV
Intervention: alendronate/vitamin D (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: St. Michael's Hospital, Toronto Official(s) and/or principal investigator(s):
Darrell Tan, MD, Principal Investigator, Affiliation: St. Michael's Hospital, Toronto
Overall contact:
Darrell Tan, MD, Phone: 4168646060, Ext: 5568, Email: darrell.tan@gmail.com
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-nave 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 Details
Official title: Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Percentage changes in BMD at a) the lumbar spine and b) proximal femur
Secondary outcome: FeasibilityAcceptability Safety/Tolerability Adherence Bone Biomarkers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Darrell Tan, MD, Phone: 4168646060, Ext: 5568, Email: darrell.tan@gmail.com
St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting
Darrell Tan, MD, Phone: 4168646060, Ext: 77505, Email: darrell.tan@gmail.com
Darrell Tan, MD, Principal Investigator
Toronto General Hospital, Toronto, Ontario M5G 2N2, Canada; Recruiting
Sharon Walmsley, MD, Phone: 4163403871, Email: sharon.walmsley@uhn.com
Sharon Walmsley, MD, Principal Investigator
Additional Information
Starting date: May 2014
Last updated: February 4, 2015
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