Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

HIV Clinical Trial

— BATARI  

Official title:

Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968850
• Other study ID #: CTNPT 021
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2013
• Last updated: April 17, 2018
• Start date: April 23, 2014
• Est. completion date: March 19, 2018

Study information

• Verified date: April 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 19, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	CIHR Canadian HIV Trials Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage changes in BMD at a) the lumbar spine and b) proximal femur	The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.	48 weeks
Secondary	Feasibility	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.	48 weeks
Secondary	Acceptability	Using standardized questions, participants will be asked about the acceptability of the alendronate therapy (including the experience of pill-taking and the weekly schedule)	48 weeks
Secondary	Safety/Tolerability	As per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.	48 weeks
Secondary	Adherence	Adherence with anti-resorptive therapy will be assessed by pill count and questionnaire.	48 weeks
Secondary	Bone Biomarkers	Two bone biomarkers will be assessed: cross-linked carboxyterminal-telopeptide (CTX) and aminoterminal propeptide of type 1 collagen (P1NP).	48 weeks