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Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial (BATARI)

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ClinicalTrials.gov Identifier: NCT01968850
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE October 9, 2013
First Posted Date  ICMJE October 24, 2013
Last Update Posted Date April 19, 2018
Actual Study Start Date  ICMJE April 23, 2014
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
  • 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.
  • Standard deviation and intra-patient correlation coefficient for the percentage changes in BMD at 48 weeks [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
  • 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.
  • 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)
  • Safety/Tolerability [ Time Frame: 48 weeks ]
    As per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
  • Adherence [ Time Frame: 48 weeks ]
    Adherence with anti-resorptive therapy will be assessed by pill count and questionnaire.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
Official Title  ICMJE Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE HIV
Intervention  ICMJE Drug: alendronate/vitamin D
once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.
Other Name: Fosavance 70/56
Study Arms  ICMJE
  • No Intervention: no bone anti-resorptive therapy
    (standard of care)
  • Experimental: 24-week tx of alendronate/vitamin D
    Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D
    Intervention: Drug: alendronate/vitamin D
  • Experimental: Delayed 24-week tx of alendronate/vitamin D
    a 24 week delay in initiation of a 24 week course of alendronate/vitamin D
    Intervention: Drug: alendronate/vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 19, 2018
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968850
Other Study ID Numbers  ICMJE CTNPT 021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE CIHR Canadian HIV Trials Network
Investigators  ICMJE
Principal Investigator: Darrell Tan, MD St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP