ACTRN12612000776808已完成4 期
Bisphosphonate Therapy with Zoledronic acid or Tenofovir Switching to Improve Low Bone Mineral Density in HIV-Infected Adults: a Strategic, Randomised Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. provision of written, informed consent
- •2. HIV infected adult equal to or greater than 18 years of age
- •3. stable and well-tolerated ART including tenofovir for the preceding 6 months
- •4. plasma HIV RNA <50 copies/ml for at least the preceding 3 months
- •5. eGFR >60ml/min (patients at higher risk of zoledronic acid/tenofovir nephrotoxicity)
- •6. spine or neck of femur T score = -1.0 measured by DXA (i.e. osteopenia)
排除标准
- •1. prior bisphosphonate therapy
- •2. use of tenofovir for previously active chronic hepatitis B co-infection
- •3. requiring therapy for low BMD (e.g. prior fragility fracture; other metabolic bone disease)
- •4. other secondary causes of osteoporosis: hypogonadism (low total testosterone/oestrogen and luteinizing hormone >25% above upper normal limit); hypothyroidism (low T4 and elevated TSH); hyperparathyroidism (elevated parathyroid hormone); inhaled fluticasone in a patient receiving ritonavir; prednisolone equal to or greater than 7.5mg/d or equivalent
- •5. contra-indications to zoledronic acid (known hypersensitivity to bisphosphonates, hypocalcaemia, prior or current uveitis, eGFR<35 mL/min)
- •6. recent (within the last 2 months) or planned dental surgery (at investigators discretion)
- •7. previous virological failure, genotypic resistance, intolerance or contraindication to proposed switch antiretroviral drug
- •8. HLA-B*5701 positive (abacavir contra-indicated) or prior ischaemic cardiovascular disease if planning to switch from tenofovir to abacavir
- •9. concurrent use of any nephrotoxic drug
- •10. breast-feeding or pregnancy
研究者
相似试验
进行中（未招募）
1 期
Treatment with Zoledronic acid or Tenofovir Switching in HIV-Infectedlow bone mineral density - HIVMedDRA version: 16.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2013-003359-39-ESFundació Clínic per a la Recerca Biomèdica84
进行中（未招募）
不适用
Effects of drug treatment with bisphosphonates (zoledronic acid) in the prevention of skeletal events in breast cancer patients with osteoporosis. Significant correlation with some biological parameters - NDMedDRA version: 12.1Level: LLTClassification code 10057654Term: Breast cancer femaleBreast cancerEUCTR2010-019216-20-ITAZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
已完成
1 期
Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases PalliationBone MetastasesProstate CancerLung CancerBreast CancerNCT00264420The Cleveland Clinic4
进行中（未招募）
1 期
Treatment with zoledronic acid subsequent to denosumab in osteoporosisMedDRA version: 20.0Level: LLTClassification code 10031289Term: Osteoporosis, unspecifiedSystem Organ Class: 100000004859OsteoporosisEUCTR2015-005529-37-DKBente Lomholt Langdahl60
进行中（未招募）
1 期
Zoledronic acid, an osteoporosis drug, in chronic low back pain with specific findings on magnetic resonance imaging: a randomized controlled trialChronic low back painMedDRA version: 18.1Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859EUCTR2015-000751-25-FIJaro Karppinen250