Trial record 18 of 35 for:    " October 07, 2013":" November 06, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

This study is not yet open for participant recruitment.
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
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:
Vitamin D
Ergocalciferols
Alendronate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014