Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
研究概览
简要总结
This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has already been proved.
详细描述
The lower bone mineral density that has been described in patients with HIV-infection has not meant an increase of long term complications. Nevertheless, it could involve an increase if the associated co-mordibity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That's why it is necessary to know the real prevalence of osteoporosis in this population of patients so the real dimensions of the problems can be defined.
This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has been already proved. If the quarterly use of endovenous ibandronate obtains equivalent results to those obtained with oral and weekly alendronate in other studies with the same population, its use would be justified because of its posology benefits. The monthly or quarterly administration can improve compliance in patients who are recieving a big quantity of drugs, as HIV infected patients do and who probably have to be treated for life. Moreover, its elimination is renal so there is absence of interactions with antiretroviral drugs what mades of ibandronate a very promising alternative. Finally, there's no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bifosfonates.
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
- None
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
- •18 years old or elder.
- •Documented HIV-1 infection, with or without antiretroviral treatment.
- •Presence of WHO osteoporosis criteria, defined as t-score under -2.5 in lumbar, hip and/or trochanter. (DEXA in the last 6 months is needed)
- •Willing to follow the study protocol.
- •Informed Consent signature.
排除标准
- •In women, pregnancy or breastfeeding.
- •Other possible causes of secondary osteoporosis.
- •Creatinin over 2.3mg/mL
- •Glomerular filter less than 50 mL/min (estimated through MDRD)
- •Alendronate treatment in the last 6 months.
研究组 & 干预措施
1
Ibandronate + Lifestyle modifications
干预措施: Ibandronate (Drug)
1
Ibandronate + Lifestyle modifications
干预措施: Lifestyle modifications (Behavioral)
2
Lifestyle modifications
干预措施: Lifestyle modifications (Behavioral)
结局指标
主要结局
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
时间窗: BL, W24, W48, W72, W96
次要结局
- Adverse events(BL, W12, W24, W36, W48, W60, W72, W80, W96)
- Lab tests(BL, W12, W24, W36, W48, W60, W72, W80, W96)
- Related clinical events (bone fractures)(BL, W12, W24, W36, W48, W60, W72, W80, W96)
- Osteoblastic/Osteoclastic activity, bone formation/reabsorption.(BL, W12, W24, W36, W48, W60, W72, W80, W96)
研究者
Dra. EUGENIA NEGREDO PUIGMAL
Principal Investigator
Germans Trias i Pujol Hospital
