NCT00120757已完成3 期
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir
French National Agency for Research on AIDS and Viral Hepatitis6 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis)
研究概览
简要总结
Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.
详细描述
The purposes of this trial are:
- To study the efficacy of alendronate in HIV-associated osteoporosis
- To measure the prevalence of osteoporosis in HIV patients and to detect risk factors in a large cohort of HIV patients from the screening phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Non-pregnant
- •Non menopausal women
- •Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%)
- •HIV infection known for at least 5 years
- •CD4 cell count over 50/mm3
- •Karnofsky score over or equal to 70
- •Written informed consent.
排除标准
- •Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria
- •Testosterone below normal if treatment is hormonal
- •BMI below or equal to 18
- •Severe lung failure
- •Chronic alcohol intoxication
- •Ongoing opportunistic infection
- •Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months
- •History of treatment for osteoporosis
- •History of malignancy in the previous 5 years (except skin cancer and Kaposi)
- •Cytotoxic chemotherapy or cytokine therapy
- •Liver cirrhosis
- •Breast feeding
结局指标
主要结局
Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis)
次要结局
- Percentage of variation of femoral T-score between M0 and M24
- Percentages of variation of lumbar and femoral T score between M0 and M12
- Evolution of bone metabolism markers
- Occurrence of fractures
- Tolerance of alendronate
- Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women
- Description of the evolution of osteoporosis in HIV-infected men and women receiving calcium and vitamin D to define risk factors for osteoporosis in HIV-infected persons
研究者
研究点 (6)
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