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Completed

NCT Number: NCT01968850

Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

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.

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Key information

Conditions

HIV Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alendronate/vitamin D

Drug

once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.

Other names: Fosavance 70/56

Primary outcomes

  1. Percentage changes in BMD at a) the lumbar spine and b) proximal femur

    Time frame: 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 outcomes

  1. Feasibility

    Time frame: 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.

  2. Acceptability

    Time frame: 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)

  3. Safety/Tolerability

    Time frame: 48 weeks

    As per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.

  4. Adherence

    Time frame: 48 weeks

    Adherence with anti-resorptive therapy will be assessed by pill count and questionnaire.

  5. Bone Biomarkers

    Time frame: 48 weeks

    Two bone biomarkers will be assessed: cross-linked carboxyterminal-telopeptide (CTX) and aminoterminal propeptide of type 1 collagen (P1NP).

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • CIHR Canadian HIV Trials Network

Registry information

Acronym: BATARI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2013
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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