Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
HIV
Drug: alendronate/vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: Delayed 24-week tx of alendronate/vitamin D
a 24 week delay in initiation of a 24 week course of alendronate/vitamin D
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968850

Contacts
Contact: Darrell Tan, MD 4168646060 ext 5568 darrell.tan@gmail.com

Locations
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Darrell Tan, MD    4168646060 ext 77505    darrell.tan@gmail.com   
Principal Investigator: Darrell Tan, MD         
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Sharon Walmsley, MD    4163403871    sharon.walmsley@uhn.com   
Principal Investigator: Sharon Walmsley, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Darrell Tan, MD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01968850     History of Changes
Other Study ID Numbers: CTNPT 021
Study First Received: October 9, 2013
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
osteoporosis
HIV
bone Mineral Density
alendronate
vitamin D

Additional relevant MeSH terms:
Alendronate
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014