Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana.
Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana.
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DOI：
10.1371/journal.pone.0090111
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Paxton LA
中科院分区：
文献类型：
--
作者：
Kasonde M;Niska RW;Rose C;Henderson FL;Segolodi TM;Turner K;Smith DK;Thigpen MC;Paxton LA
替诺福韦-恩曲他滨（TDF-FTC）暴露前预防（PrEP）在几项临床试验中被发现可有效预防HIV感染。在男男性行为者中进行的两项TDF PrEP研究显示，骨密度（BMD）略有下降。我们调查了TDF的效果和TDF和激素避孕对未感染HIV的非洲男性和女性的BMD的相互作用。我们评估了在博茨瓦纳TDF 2 PrEP研究中招募的18-29岁异性恋男性和女性中，与安慰剂相比，每日口服TDF-FTC对BMD的影响。参与者在基线时和此后每隔6个月在臀部、脊柱和前臂进行双能X线吸收测定法（DXA）扫描进行BMD测量。共有220名参与者（108名TDF-FTC，112名安慰剂）在三个解剖部位进行了基线DXA BMD测量。15名（6.8%）受试者基线BMD较低（任何解剖部位z评分<-2.0），包括3/114名女性（2.6%）和12/106名男性（11.3%）（p = 0.02）。 基线骨密度低与体重不足（p = 0.02）、血尿素氮高（p = 0.02）或碱性磷酸酶高（p = 0.03）和肌酸酐清除率低（p = 0.04）相关。 TDF-FTC治疗组在基线后任何时间任何解剖部位的BMD损失>3.0%显著更大[34/68（50.0%）TDF-FTC vs. 26/79（32.9%）安慰剂; p = 0.04]。 第30个月时，TDF-FTC组与安慰剂组相比，所有3个部位BMD较基线的平均百分比变化存在较小但显著的差异[前臂−0.84%（p = 0.01），脊柱−1.62%（p = 0.0002），髋关节−1.51%（p = 0.003）]。 使用TDF-FTC与前臂、髋关节和腰椎BMD的小幅但统计学显著性降低相关。高比例（6.8%）的健康的蝙蝠侠年轻人有异常的基线BMD。需要进一步评估TDF在HIV未感染者中的长期使用。ClinicalTrials.gov NCT00448669
Tenofovir-emtricitabine (TDF-FTC) pre-exposure prophylaxis (PrEP) has been found to be effective for prevention of HIV infection in several clinical trials. Two studies of TDF PrEP among men who have sex with men showed slight bone mineral density (BMD) loss. We investigated the effect of TDF and the interaction of TDF and hormonal contraception on BMD among HIV-uninfected African men and women. We evaluated the effects on BMD of using daily oral TDF-FTC compared to placebo among heterosexual men and women aged 18–29 years enrolled in the Botswana TDF2 PrEP study. Participants had BMD measurements at baseline and thereafter at 6-month intervals with dual-energy X-ray absorptiometry (DXA) scans at the hip, spine, and forearm. A total of 220 participants (108 TDF-FTC, 112 placebo) had baseline DXA BMD measurements at three anatomic sites. Fifteen (6.8%) participants had low baseline BMD (z-score of <−2.0 at any anatomic site), including 3/114 women (2.6%) and 12/106 men (11.3%) (p = 0.02). Low baseline BMD was associated with being underweight (p = 0.02), having high blood urea nitrogen (p = 0.02) or high alkaline phosphatase (p = 0.03), and low creatinine clearance (p = 0.04). BMD losses of >3.0% at any anatomic site at any time after baseline were significantly greater for the TDF-FTC treatment group [34/68 (50.0%) TDF-FTC vs. 26/79 (32.9%) placebo; p = 0.04]. There was a small but significant difference in the mean percent change in BMD from baseline for TDF-FTC versus placebo at all three sites at month 30 [forearm −0.84% (p = 0.01), spine −1.62% (p = 0.0002), hip −1.51% (p = 0.003)]. Use of TDF-FTC was associated with a small but statistically significant decrease in BMD at the forearm, hip and lumbar spine. A high percentage (6.8%) of healthy Batswana young adults had abnormal baseline BMD Further evaluation is needed of the longer-term use of TDF in HIV-uninfected persons. ClinicalTrials.gov NCT00448669
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影响因子：
4.2
作者：
BELL, NH;GORDON, L;SHARY, JR
通讯作者：
SHARY, JR
影响因子：
120.7
作者：
LLOYD, T;ANDON, MB;KULIN, HE
通讯作者：
KULIN, HE
DOI：
10.1097/01.qai.0000167155.44980.e8
发表时间：
2005-08-01
影响因子：
3.6
作者：
Hawkins, T;Veikley, W;Kearney, BP
通讯作者：
Kearney, BP
影响因子：
158.5
作者：
JOHNSTON, CC;MILLER, JZ;PEACOCK, M
通讯作者：
PEACOCK, M
影响因子：
105.7
作者：
Winzenberg, Tania;Shaw, Kelly;Jones, Graeme
通讯作者：
Jones, Graeme