EUCTR2014-004819-37-GB进行中（未招募）1 期
A multi-centre, prospective, randomised trial of short course alendronate therapy or placebo combined with vitamin D and calcium to prevent loss of bone mineral density in antiretroviral-naïve, HIV-1 infected subjects initiating antiretroviral therapy. - Alendronate for Prevention of ART-associated bone loss (APART study)
niversity College Dublin0 个研究点目标入组 80 人开始时间: 2018年8月2日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •male>25 years old or female>30 years old
- •HIV-1 antibody positive (no CD4 or HIV RNA criteria)
- •antiretroviral therapy naïve (Not having had suppressive ART in the previous 12 months to enrollment)
- •be presumed to have achieved peak bone mass
- •eligible for initiation of antiretroviral therapy in the opinion of the investigator
- •able to provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- •subjects unable to comply with the study protocol or unable to stand/sit upright for at least 30 minutes
- •history of osteoporosis (defined as hip, femoral neck or spine T score of <-2.5 in men over age >50 or in post-menopausal women)
- •history of fragility fracture or previous femoral fracture
- •chronic renal failure (estimated GFR<60mls/min/1.73m2)
- •hypocalcaemia (corrected calcium<2.2mmol/L) or hypercalcaemia (>2.6mmol/L) at screening
- •history of Paget’s disease or known primary hyperparathyroidism
- •previous treatment with or allergy (including hypersensitivity) to bisphosphonates
- •recent history (past 12 months) of peptic or duodenal ulcers or oesophagitis, aspiration or any other upper-gastrointestinal problem or oesophageal disease that in the opinion of the investigator precludes the use of alendronate
- •history of dental disease, periodontal disease, poor oral hygiene (as judged in the opinion of the investigator) or recent invasive dental procedures (within the past 3 months) comprising dental extraction and dental prosthetic
- •current therapy with prescribed calcium or vitamin D preparations (other than over-the-counter multivitamin preparations)
- •current therapy with aspirin or other regularly prescribed non-steroidal anti-inflammatory drugs
- •recent significant steroid exposure defined as continual or cumulative use of >5mg prednisolone daily or equivalent for = three months, as per EACS guidelines
- •for female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
- •where in the investigator’s opinion, there is a necessity to initiate ART within the pre-ART study window period
- •hepatitis B (sAg positive) or hepatitis C (Ab and RNA positive) co-infection
- •any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study.
- •subjects concurrently enrolled in another clinical trial of an investigational medical product
研究者
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