EUCTR2005-002785-10-HU进行中（未招募）不适用
A Phase III, Multicenter, Double-Blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly with 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis as Assessed at 12 and 24 Months. 2005032 (EFC6062) (HMR4003K/3001) - MERIT-OP
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
- 1,068
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
- •a) be female, ambulatory, and 50 years of age or older;
- •b) be in generally good health;
- •c) be postmenopausal (= 5 years since last menses, natural or surgical);
- •d) have at least 3 evaluable lumbar spine vertebral bodies (L1-L4), namely without fracture or degenerative disease;
- •e) meet one of the following lumbar spine BMD criteria:
- •have lumbar spine BMD (L1-L4) less than 0.772 g/cm2 (Hologic) or 0.880 g/cm2
- •(Lunar), corresponding to a BMD more than 2.5 SD below the young adult female
- •mean value, or
- •have lumbar spine BMD (L1-L4) less than 0.827 g/cm2 (Hologic) or 0.940 g/cm2
- •(Lunar), corresponding to a BMD more than 2.0 SD below the young adult female
- •mean value, and at least one prevalent vertebral body fracture (T4-L4);
- •f) be willing and able to provide written informed consent.
- •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
- •a) any previous or ongoing clinically significant illness
- •b) abuse of alcohol,
- •c) abuse of prescription or illicit drugs,
- •d) any condition or disease that may interfere with the evaluation of lumbar spine BMD as determined in a Screening radiograph by a radiologist at the central
- •e) bilateral hip prostheses;
- •f) history of hyperparathyroidism,
- •g) uncontrolled hyperthyroidism or ongoing osteomalacia at the time of enrollment;
- •h) any history of cancer within past 5 years, except for basal cell carcinoma and dermalsquamous cell carcinoma with documented 6-month remission. Patients with a recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission;
- •i) a Body Mass Index > 32 kg/m2;
- •j) any known allergic or abnormal reaction to bisphosphonates;
- •k) use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:
- •oral glucocorticoids = 5 mg prednisone or equivalent/day;
- •anabolic steroids
- •estrogens except for low dose vaginal creams, tablets or insertable estrogen ring
- •progestins
- •calcitonin
- •vitamin D supplements (> 1000 IU per day)
- •calcitriol, calcidiol, or alfacalcidol at any dose
- •any bisphosphonate
- •fluoride (= 10 mg/day)
- •strontium (= 50 mg/day)
- •products in the phytoestrogen or isoflavone classes
- •l) depot injection > 12,000 IU vitamin D in the past 9 months;
- •m) markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the Investigator (Appendix 1);
- •n) creatinine clearance of < 30 mL/min,
- •o) hypocalcemia or hypercalcemia from any cause;
- •p) serum thyroid stimulating hormone (TSH) value outside the permissible range of 0.38-9.99 mU/L. (
- •q) serum 25-hydroxy vitamin D level < 12 ng/mL (30 nmol/L);
- •r) participation in another clinical trial 30 days prior to Screening;
- •s) demonstrated poor likelihood of completing the study and complying with protocol
研究者
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