Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01968850
First received: October 9, 2013
Last updated: March 12, 2014
Last verified: March 2014

October 9, 2013
March 12, 2014
April 2014
September 2015   (final data collection date for primary outcome measure)
Percentage changes in BMD at a) the lumbar spine and b) proximal femur [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.
Same as current
Complete list of historical versions of study NCT01968850 on ClinicalTrials.gov Archive Site
  • Feasibility [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    As per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
  • Adherence [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Adherence with anti-resorptive therapy will be assessed by pill count and questionnaire.
  • Bone Biomarkers [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Two bone biomarkers will be assessed: cross-linked carboxyterminal-telopeptide (CTX) and aminoterminal propeptide of type 1 collagen (P1NP).
Same as current
Not Provided
Not Provided
 
Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Darrell Tan, MD 4168646060 ext 5568 darrell.tan@gmail.com
Canada
 
NCT01968850
CTNPT 021
Yes
St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
CIHR Canadian HIV Trials Network
Principal Investigator: Darrell Tan, MD St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
March 2014

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