EUCTR2006-005893-37-IT进行中（未招募）不适用
A one year multicenter, randomized, double-blind, placebocontrolled, parallel group study to evaluate the efficacy and safety of a single intravenous 5 mg dose zoledronic acid for the treatment of osteoporosis in men - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
- Male
入选标准
- •Male patients between 50 and 85 years of age, inclusive Bone mineral density T-score of less than or equal to -2.5 SD at the total hip or femoral neck AND less than or equal to -1.5 SD at the lumbar spine as confirmed by the central expert reader
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with 25- OH Vitamin D levels less than 15 ng/mL at Visit 1. If the vitamin D level is 15 ng/ml the patient should receive a loading dose of 75,000-100,000 IU of vitamin D i.m. or orally once at Visit 1 and have the vitamin D test repeated at Visit 1A to be done after at least 3 weeks have passed . Baseline renal insufficiency calculated creatinine clearance less than 30.0 mL/min at Visit 1 and/or Visit 1A Serum calcium less than or equal to 2.0 mmol/L 8.0 mg/dL at Visit 1 or Visit 1A AST or ALT greater than three times the upper limit of normal Serum alkaline phosphatase greater than 1.5 times the upper limit of normal Any disease or deformation of the spine that would preclude the proper acquisition of a lumbar spine DXA L1-L4 e.g. implantable devices, scoliosis, ankylosing spondylitis
研究者
相似试验
进行中（未招募）
不适用
A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALTEUCTR2009-011888-37-DEovartis Pharma GmbH
进行中（未招募）
不适用
A two year multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the fracture efficacy and safety of intravenous zoledronic acid 5 mg annually for the treatment of osteoporosis in men - NATreatment of osteoporosis in menMedDRA version: 8.1Level: LLTClassification code 10031282Term: OsteoporosisEUCTR2004-004131-57-FIovartis Pharma Services AG1,072
进行中（未招募）
不适用
A two year multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the fracture efficacy and safety of intravenous zoledronic acid 5 mg annually for the treatment of osteoporosis in men - NATreatment of osteoporosis in menEUCTR2004-004131-57-HUovartis Pharma Services AG1,072
进行中（未招募）
1 期
A two year multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the fracture efficacy and safety of intravenous zoledronic acid 5 mg annually for the treatment of osteoporosis in men - CZOL446M2309EUCTR2004-004131-57-GBovartis Pharma Services AG
进行中（未招募）
不适用
A two year multicenter, randomized, double-blind, placebocontrolled, parallel group study to evaluate the fracture efficacy and safety of intravenous zoledronic acid 5 mg annually for the treatment of osteoporosis in meosteoporosisMedDRA version: 14.1Level: PTClassification code 10031282Term: OsteoporosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2004-004131-57-ITOVARTIS FARMA1,072