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

This study is currently recruiting participants.
Verified April 2016 by St. Michael's Hospital, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968850
First Posted: October 24, 2013
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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).


Estimated Enrollment: 30
Study Start Date: May 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968850


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

Locations
Canada, Ontario
St. Michael's Hospital 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 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

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01968850     History of Changes
Other Study ID Numbers: CTNPT 021
First Submitted: October 9, 2013
First Posted: October 24, 2013
Last Update Posted: April 18, 2016
Last Verified: April 2016

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

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