Trial intelligence / Profile preview

BATARI: Alendronate/vitamin D for bone loss in HIV

NCT01968850Phase 2

Key facts

Status: Completed
Start: Apr 2014
Primary completion: Mar 2018
Countries: 1
Sponsor: Unity Health Toronto
Modality: Small Molecules

Drugs: alendronate
Conditions: osteoporosis

Overview

Phase 2, randomised, open-label trial of alendronate in osteoporosis (3 arms), sponsored by Unity Health Toronto. Primary endpoint: Percentage changes in Bone Mineral Density at lumbar spine and proximal femur at 48 weeks. Started Apr 2014; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

No bone anti-resorptive therapy
Standard of Care
Immediate alendronate/vitamin D
24-week course starting at baseline
Delayed alendronate/vitamin D
24-week course starting at week 24

Who it enrols

Adults with documented HIV-1 infection initiating first-line ART, with low fracture risk and no established osteoporosis.

Endpoints

Primary

Percentage changes in Bone Mineral Density at lumbar spine and proximal femur48 weeks

Secondary

Feasibility48 weeks
Acceptability48 weeks
Safety and Tolerability48 weeks
Adherence48 weeks
Bone Biomarkers48 weeks

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