EUCTR2006-001703-11-DE进行中（未招募）不适用
A multi-center, randomized, open-label, controlled, one-year trial to measure the effect of zoledronic acid and alendronate on bone metabolism in post menopausal women with osteopenia and osteoporosis - ROSE
ovartis Pharma GmbH0 个研究点开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Female
入选标准
- •1.women equal to or older than 55 and up to 90 years (inclusive) at randomization who will be considered post-menopausal according to the following definition:
- •a.= 12 months of natural (spontaneous) amenorrhea or
- •b.= 12 month post surgical bilateral oophorectomy or
- •c.hysterectomized women under 65 years of age with a serum FSH > 20 IU/l and estradiol < 10 pg/ml
- •d.hysterectomized women over or equal to 65 years of age
- •2.documented T-score of -2.0 or lower; total hip or spine (mean of L1-L4, excluding fractured vertebrae); measured by DXA; measured within a period of 3 month prior to screening
- •3.signed informed consent prior to initiation of any study procedure
- •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
- •1.any woman of child-bearing potential
- •2.pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
- •3.history of fractures within six month prior to randomization
- •4.calculated creatinine clearance below 35 ml/min or urine dipstick 2+ or more for protein (without evidence of contamination or bacteriuria)
- •5.serum calcium > 2.75 mmol/l (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL)
- •6.serum alkaline phosphatase higher than 2.5 times the upper limit of normal
- •7.history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •8.AST or ALT greater than twice the upper limit of normal
- •9.history of uveitis, iritis or chronic conjunctivitis
- •10.history of retinopathy or nephropathy especially in the presence of uncontrollable IDDM Hb1AC > 10%.
- •11.history of abnormalities of the esophagus which may delay esophageal emptying.
- •12.not being able to stand or sit upright for 30 minutes
- •13.history of invasive malignancy of any organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases; excluding basal cell or squamous cell carcinoma of the skin.
- •14.treatment with an investigational drug within the past 30 days or 5 half-lives prior to randomization whichever is longer
- •15.history of organ transplantation
- •16.history of hypoparathyroidism, hyperparathyoidism, osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
- •17.any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 12 months
- •18.any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial.
- •19.previous use of oral and i.v. bisphosphonates, PTH, strontium ranelate, sodium fluoride.
- •20.raloxifene, calcitonin,, tibolone or hormone replacement therapy within 6 months prior to randomization.
- •21.use of systemic high dose corticosteroids within 6 months prior to screening:
- •a.at an average dose of =?7.5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening or
- •b.at an average dose of 2.5 mg per day of oral prednisone or equivalent for a period of 6 months or more prior to screening
- •22.any treatment that affects bone metabolism (e.g. antiepileptics)
- •23.bilateral hip and spine surgery, that may interfere with the DXA measurements (e.g. hip replacement)
- •24.any kind of tooth extraction during the last 3 months or surgery of the jaw during the last 6 month before inclusion in the study
- •25.any kind of jaw bone disease or infection, that may necessitate oral surgery during the course of the study
- •26.history of drug or alcohol abuse within the last 2 years
- •27.history of non-compliance to medical regimens, or those patients unwilling to comply with the trial protocol.
- •28.any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing it
- •29.unwillingness or inability to give informed consent
- •30.persons directly involved in the execution of this protocol
- •31.any disease related litigation
- •32.recent history of kidney st
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