EUCTR2005-001511-22-GB进行中（未招募）1 期
A 24-Month Extension to: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Postmenopausal Women with Osteoporosis - Cat-K 11b Osteoporosis Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 399
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
- •Postmenopausal female (> 5 years) between 45-85 years old.
- •T-score at the hip (femoral neck, trochanter or total) or lumbar spine <-2.0, but not < -3.5.
- •The patient has spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumbar spine with no evidence of vertebral fractures in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.)
- •The patient has a 25-hydroxyvitamin D level =15 ng/dL. If the level is = 9 and < 15 ng/dL, she may enter if her alkaline phosphatase and PTH levels are normal.
- •The patient has no evidence of a metabolic bone disorder other than osteopenia or osteoporosis.
- •The patient understands the procedures of the study, has been informed of potential alternative treatments for osteoporosis, and is willing to give written informed consent for participation.
- •The patient agrees not to use medications for the treatment of osteoporosis (except as provided through this study) for the duration of her participation in the trial.
- •Extension phase: Patient has participated and completed 24 months of treatment in base study, is generally in good health based on medical history, physical examination and laboratory evaluation.
- •extension phase: Patient has completed base study and is generally in good health based on medical history, physicial examination and laboratory examination.
- •extension phase to 10 yrs: has completed 60 months of treatment in protocols 004-02, 044-11, and 044-22. met all initial inclusion criteria and not met any exclusion criteria.
- •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
- •Base study: The patient has a BMD T-score at the spine or hip (femoral neck, trochanter, or total) <-3.5.
- •The patient has a history of prior hip, spine, or other fragility fracture since menopause (UNLESS the patient is unwilling to take, or is ineligible for, other osteoporosis therapy [bisphosphonates or PTH]).
- •The patient has received any agents with action on bone including the following: a) anabolic steroids or glucocorticoids (= 5 mg/day prednisone or equivalent) for more than 2 weeks in the prior 6 months, b) bisphosphonates (any oral use within the past 6 months; = 2 weeks use within the past 12 months; or > 2 months use at any time), or any I.V. bisphosphonates, c) cyclosporin for more than 2 weeks within the prior 6 months, d) fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks at any time, e) strontium (at any time) f) PTH within 12 months, g) current use of phenytoin, chemotherapy, or heparin, or h) use of growth hormone at any time.
- •The patient has used estrogen ± progestin, raloxifene or other SERM, tamoxifen, tibolone, or an aromatase inhibitor within the prior 6 months or calcitonin within the prior 30 days. (Note: Vaginal estrogen creams used topically = twice weekly will be permitted).
- •The patient is currently taking Vitamin A (excluding beta carotene) > 10,000 IU daily or Vitamin D > 5,000 IU daily and not willing to discontinue this dose during the study.
- •The patient has primary parathyroid disease with an elevated PTH or in conjunction with serum calcium greater than the upper limit of normal. (Note: patients with a history of primary hyperparathyroidism and with curative parathyroidectomy = 2 years are not excluded).
- •The patient has a TSH < 0.1 ng/dL.
- •The patient has hypocalcemia as defined as serum calcium <8.5 ng/dL, when corrected for albumin, or evidence of secondary hyperparathyroidism.
- •Patients with a) a history of marked baseline prolongation of QT/QTc interval (eg. repeated demonstration of a QTc interval >450), or b) additional risk factors for Torsades de Pointes (eg. heart failure, hypokalemia, family history of Long QT Syndrome), or c) concomitant use of medications that prolong the QT/QTc interval (eg. quinidine, procainamide, disopyramide, tricyclic antidepressants, phenothiazines, amiodarone or sotalol) will be excluded.
- •The patient has significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient.
- •The patient has a significant, unexplained laboratory abnormality.
- •The patient has cancer or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- •The patient is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the patient cannot read or comprehend the written material.
- •The patient has participated in an investigational drug study within the past 30 days.
- •The patient is currently a user of any illicit drug and/or has a history of alcohol abuse.
- •The patient demonstrates noncompliance in following the procedur
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