EUCTR2004-004131-57-GB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 - CZOL446M2309
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Male patients between 50 and 85 years of age, inclusive
- •At least three readable L1-L4 vertebra, confirmed by the centralized expert readers prior to randomization
- •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.
- •Bone mineral density T-score of less than or equal to -1.5 SD at the total hip or femoral neck as confirmed by the central expert reader, AND at least 1 up to a maximum of 3 prevalent vertebral fractures of mild or moderate grade as defined by the modified Genant method for males and confirmed by the central expert reader.
- •Important: The BMD T-score must be confirmed by the central expert reader prior to randomization. Additionally, vertebral x-rays (lateral thoracic and lumbar views) will be performed and must be submitted to the central imaging laboratory for confirmation of prevalent vertebral fractures prior to randomization.
- •Please note: Patients with more than 3 or any severe vertebral fracture or patients with acute painful osteoporotic fractures requiring treatment with any of the prohibited medications can not be included in the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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 IM or orally once at visit 1 and have the vitamin D test repeated at
- •visit 1A. This repeat test for vitamin D should be done after at least 3 weeks have
- •passed since the loading dose was given.
- •Baseline renal insufficiency (calculated creatinine clearance less than 30.0 mL/min)
- •at Visit 1 and/or Visit 1A or urine dipstick greater than or equal to 2+ protein
- •without evidence of contamination or bacteriuria (may be repeated one time at
- •least a week apart if there is suspicion of contamination). Patients with calculated
- •creatinine clearance equal to or greater than 30.0 mL/min and less than 60.0
- •mL/min or serum creatinine greater than the upper limit of normal at Visit 1 must
- •be confirmed at a second visit (Visit 1A). Patients with calculated creatinine
- •clearance greater than 60.0 mL/min and serum creatinine within normal limits at
- •Visit 1 do not require re-test.
- •Patients who require re-test of creatinine clearance at Visit 1A will be excluded if
- •there is an increase in serum creatinine greater than 0.5 mg/dL between Visit 1
- •and Visit 1A. Serum creatinine may be repeated once and the investigator may
- •discuss with the Novartis Clinical Research Physician whether to consider the
- •patient’s entry into the trial based on the repeated serum creatinine result and
- •the patient’s overall renal status.
- •Hypercalcemia, defined as serum calcium greater than or equal to 2.75 mmol/L
- •(11.0 mg/dL) at Visit 1 or Visit 1A.
- •Hypocalcemia, defined as 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 3 times the upper limit of normal
- •Serum alkaline phosphatase greater than 1.5 times the upper limit of normal
- •Previous use of calcitonin except according to the following washout schedule,
- •measured from randomization:
- •- 6 months (if used for 12 weeks or longer)
- •- 3 months (if used for greater than or equal to 4 weeks but less or equal to 12
- •Hypersensitivity to bisphosphonates
- •Prior treatment with i.v. bisphosphonates within the last 2 years prior to
- •randomization
- •Use of oral bisphosphonates except according to the following washout schedule,
- •measured from the date of randomization:
- •- 2 years (if used for 48 weeks or longer)
- •- 1 year (if used for greater than 8 weeks but less than 48 weeks)
- •- 6 months (if used for greater than 2 weeks but less than or equal to 8 weeks)
- •Any prior use of PTH for more than 1 week; if used for less than or equal to 1
- •week, the washout period for PTH is 3 months prior to randomization.
- •Any prior use of strontium ranelate or sodium fluoride
- •Use of testosterone therapy within one year prior to
研究者
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