Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

NCT ID: NCT01968850

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-23
• Study Completion Date: 2018-03-19

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

no bone anti-resorptive therapy

(standard of care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

24-week tx of alendronate/vitamin D

Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D

Group Type: EXPERIMENTAL

alendronate/vitamin D

Intervention Type: DRUG

once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.

Delayed 24-week tx of alendronate/vitamin D

a 24 week delay in initiation of a 24 week course of alendronate/vitamin D

Group Type: EXPERIMENTAL

alendronate/vitamin D

Intervention Type: DRUG

once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.

Interventions

alendronate/vitamin D

once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.

Intervention Type: DRUG

Other Intervention Names

Fosavance 70/56

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darrell Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CTNPT 021

Identifier Type: -

Identifier Source: org_study_id