Clinical trial NCT01968850: Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
Official title: Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: osteoporosis
HIV
bone Mineral Density
alendronate
vitamin D
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: CIHR Canadian HIV Trials Network
First posted: 2013-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Percentage changes in BMD at a) the lumbar spine and b) proximal femur
timeFrame: 48 weeks
Secondary outcomes:
measure: Feasibility
timeFrame: 48 weeks
measure: Acceptability
timeFrame: 48 weeks
measure: Safety/Tolerability
timeFrame: 48 weeks
measure: Adherence
timeFrame: 48 weeks
measure: Bone Biomarkers
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Darrell Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: