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临床试验/NCT00795483
NCT00795483已完成4 期

Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
33
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

The purpose of this project is to determine the incidence of osteoporosis in the investigators' population of HIV-infected patients and to assess the efficacy and security of zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment and in Paget's disease treatment has already been demonstrated.

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-morbidity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That is 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 zoledronic acid. If the annual use of endovenous zoledronic acid 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 annual administration can improve compliance in patients who are receiving 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 makes of zoledronic acid a very promising alternative. Finally, there is no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bisphosphonates.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old or older.
  • 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.
  • Creatinine over 2.3 mg/mL.
  • Glomerular filter less than 50 mL/min (estimated through MDRD).
  • Treatment for Osteoporosis in the last 4 months.

研究组 & 干预措施

3-BIENNIAL

Experimental
  1. Zoledronic acid + Lifestyle modifications (experimental)

干预措施: Lifestyle modifications (Behavioral)

1-ANNUAL

Experimental
  1. Zoledronic acid + Lifestyle modifications (experimental)

干预措施: Zoledronic acid (Drug)

1-ANNUAL

Experimental
  1. Zoledronic acid + Lifestyle modifications (experimental)

干预措施: Lifestyle modifications (Behavioral)

2-CONTROL

Other
  1. Lifestyle modifications (control)

干预措施: Lifestyle modifications (Behavioral)

3-BIENNIAL

Experimental
  1. Zoledronic acid + Lifestyle modifications (experimental)

干预措施: Zoledronic acid (Drug)

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: Evolution from baseline to week 96

次要结局

  • Adverse events(From baseline to week 96)
  • Lab tests(Evolution from baseline to week 96)
  • Related clinical events (bone fractures)(From baseline to week 96)
  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption.(Evolution from baseline to week 96)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dra. EUGENIA NEGREDO PUIGMAL

Eugenia Negredo

Germans Trias i Pujol Hospital

研究点 (1)

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