Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage changes in BMD at a) the lumbar spine and b) proximal femur
研究概览
简要总结
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:
- no bone anti-resorptive therapy (standard of care)
- concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
24-week tx of alendronate/vitamin D
Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D
干预措施: alendronate/vitamin D (Drug)
Delayed 24-week tx of alendronate/vitamin D
a 24 week delay in initiation of a 24 week course of alendronate/vitamin D
干预措施: alendronate/vitamin D (Drug)
结局指标
主要结局
Percentage changes in BMD at a) the lumbar spine and b) proximal femur
时间窗: 48 weeks
The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.
次要结局
- Feasibility(48 weeks)
- Acceptability(48 weeks)
- Adherence(48 weeks)
- Bone Biomarkers(48 weeks)
- Safety/Tolerability(48 weeks)