EUCTR2006-000011-15-FI进行中（未招募）不适用
A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of once monthly inbandronate in the prevention of glucocorticoid-induced osteoporosis in postmenopausal women (ML20088)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Roche Oy
- 入组人数
- 150
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. Postmenopausal women
- •2. = 1 years from menopause
- •3.Age 50-85
- •4.Having diagnosis of any inflammatory rheumatoid disease including polymyalgia rheumatica
- •5.Receiving treatment with 5-15 mg/day of prednisone
- •6.Mean lumbar spine (L1-L4) BMD = -2.0
- •7.Treatment for rheumatic disease stable for 3 months before entering the study
- •8.Presumably 5-15 mg/day prednisone treatment for at least one year
- •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.Clinical osteoporotic fractures
- •2.Femoral neck BMD < -2.0
- •3.Conditions that may interfere with the evaluation of spinal or hip osteoporosis by DXA such as 2 or more vertebral fractures L1-L4.
- •4.Hypersensitivity to any component of ibandronate
- •5.Contraindication to calcium or vitamin D therapy
- •6.nability to stand or sit in an upright position for at least 60 minutes
- •7.Inability to swallow a tablet whole
- •8.Serum Total Ca2+ > 2.6 or < 2.0 mmol/l
- •9.Renal impairment defined by creatinine clearance <30 ml/min (calculated)
- •10.Administration of any investigational drug within 30 days preceding the first dose of study drug
- •11.Previous treatment with an oral bisphosphonate within the last 6 months, more than 1 month of treatment within the last year, more than 3 months of treatment within the last two years
- •12.Previous treatment with an IV bisphosphonate at any time
- •13.Treatment with PTH in the past 2 years
- •14.Treatment with other drugs affecting bone metabolism within the last 6 months e.g., estrogens (except for vaginal administration), progestins, selective estrogen receptor modulators (SERMs), calcineurin inhibitors, anabolic steroids/androgens, active vitamin D analogs/metabolites (alfacalcidol, calcitriol), calcitonin
- •15.Active disease/disorder known to influence bone metabolism, such as untreated or uncontrolled hyperthyroidism, hyperparathyroidism, osteomalacia, liver disease, chronic alcoholism or severe malabsorption syndrome
- •16.Malignant disease (except resected basal cell cancer and treated cervic carcinoma in situ)
- •17.untreated celiac disease
- •18.History of major upper GI disease defined by:
- •- Significant upper GI bleeding within the last year requiring hospitalization or transfusion;
- •- Recurrent peptic ulcer disease documented by radiographic or endoscopic means;
- •- Dyspepsia or gastroesophageal reflux that is uncontrolled by medication;
- •- Abnormalities of the esophagus that delay esophageal emptying, such as stricture, achalasia, or dysmotility, and
- •- Active gastric/duodenal ulcers
- •Patients are not excluded because of previous or active gastrointestinal disease, except as outlined above (eg. symptoms of dyspepsia controlled by daily medication or prior history of non-recurrent peptic ulcer disease are not considered exclusionary).
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