Comparative Study of Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV + Men Being Given Tenofovir With FTC, Emtricitabine (TRUVADA®), or Without (VIREAD®), as Part of Their Antiretroviral Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA)
研究概览
简要总结
HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality.
The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.
详细描述
Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be studied using a HR-pQCT scan (Xtreme, Scanco).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV+ patients
- •male patients
- •patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months.
排除标准
- •chronic use of fluoroquinolones, antifungal agents, steroids
- •malignancy (current or previous) requiring chemotherapy or radiotherapy
结局指标
主要结局
Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA)
时间窗: ongoing, during the study period, according to the availability of DXA
次要结局
未报告次要终点
研究者
Célia Lloret-Linares, MD PhD
Professor, Medicine A Department,
Hopital Lariboisière