ATN 109 Bone Fracture Form: Bone Fracture Details [CRF 87] Dataset in Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 Supplement to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in HIV Positive Youth Treated with ART Containing Tenofovir

Data from Bone Fracture Form: Bone Fracture Details [CRF 87]
Study Description
A randomized, double-blind, placebo-controlled trial of directly observed vitamin D versus placebo every 4 weeks for 48 weeks. Participants included HIV-infected youth ages 16-24 with viral load <200 copies/mL, and taking TDF-containing combination antiretroviral therapy for >180 days. Whole-body, spine, and hip BMD and BMC were assessed using DXA at baseline and at study weeks 24 and 48.

Behaviorally-acquired HIV-positive youth, aged 16 to 24

源自骨折病例报告表：骨折详情[CRF 87]
研究概况
本研究为一项随机、双盲、安慰剂对照试验，旨在评估每4周一次直接督导下服用维生素D与安慰剂的干预效果，干预周期共计48周。受试对象为16至24岁的HIV感染青年，其病毒载量低于200拷贝/毫升，且已接受含替诺福韦酯(TDF)的联合抗反转录病毒治疗超过180天。分别于基线、研究第24周及第48周，采用双能X线骨密度仪(DXA)检测受试者全身、脊柱及髋部的骨密度(BMD)与骨矿含量(BMC)。
经行为途径感染HIV的16至24岁青年