EUCTR2004-004131-57-DE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 - NA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,072
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
- •At least three readable L1-L4 vertebra, confirmed by the centralized expert readers prior to randomization: only applicable for patients qualifying via BMD at the lumbar spine and/or belonging to the subset of at least 100 patients at the selected sites. For details regarding the imaging assessments of the subset of patients at the selected sites, please see Section 7.4.3.
- •Bone mineral density T-score of less than or equal to -2.5 SD at the total hip or femoral neck OR less than or equal to -2.5 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.
- •As per Amendment 2, this inclusion criterion is not applicable in Finland.
- •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. In Denmark, patients with a BMD T-score below -3 cannot be included if they have any moderate vertebral fractures OR if they have more than 1 moderate vertebral fracture despite the t-score level.
- •For details regarding the imaging assessments please see Section7.4.
- •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 2.0 mg/dL at Visit 1 must
- •be verified at a second visit (Visit 1A). The average creatinine clearance of the two tests must be equal to or greater than 30.0 mL/min and the result of the creatinine retest must be below or equal to 2.0 mg/dL. (Patients with calculated creatinine
- •clearance greater than 60.0 mL/min and serum creatinine below or equal to 2.0 mg/dL at Visit 1 do not require re-test.). In the UK, patients with a urine dipstick result greater than trace protein without evidence of contamination or bacteriuria cannot be included.
- •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 randomization.
- •Chronic use of systemic corticosteroids (oral or i.v.) within the last year:
- •NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled
- •formulations or those injected locally (intra-articularly) are NOT exclusionar
研究者
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