EUCTR2008-001153-17-IT进行中（未招募）不适用
Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled,Clinical Trial to Evaluate the Efficacy and Safety of MK-0217A/Alendronate Sodium70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in theTreatment of Osteoporosis in Postmenopausal Women.
MSD ITALIA S.R.L.0 个研究点目标入组 840 人开始时间: 2008年10月13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
- 入组人数
- 840
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
- All
入选标准
- •Patient is a woman and is ≥ 65 years of age on the day of signing informed consent.
- •2. Patient meets one of the following BMD criteria:
- •2.1 Patient has BMD T-score ≤ -2.5 in at least one of the anatomic sites including
- •lumbar spine, total hip, and femoral neck, OR
- •2.2 Patient has prior non-pathological fragility fracture (of hip, spine, wrist, humerus
- •or clavicle) and BMD T-score ≤ -1.5 in at least one of the anatomic sites
- •including lumbar spine, total hip, and femoral neck sites,3. Patient has been postmenopausal for at least one year. Postmenopause is defined as
- •no menses for at least one year, OR 6 months of spontaneous amenorrhea with serum
- •FSH levels > 40 mIU/mL, OR at least 6 months after a surgical bilateral
- •oophorectomy with or without hysterectomy.
- •4. Patient has increased risks of falls and meets all followings:
- •4.1 At least one or more falls within the past 12 months. The study investigators
- •should determine the prior falls primarily based on patients' self-reporting or
- •recall with or without medical records or documents.
- •4.2 Reduced lower extremity physical function. This is defined by having a
- •summary score between 4 and 9 on SPPB at Screening (Visit 1).
- •4.3 Low level of serum 25(OH)D. Baseline level of 25(OH)D should be ≥ 8 ng/mL
- •(20 nmol/L), but ≤ 20 ng/mL (50 nmol/L) at Screening (Visit 1).
- •5. Patient understands the study procedures, available alternative treatments and risks
- •involved with the study, and voluntarily agrees to participate by signing a written
- •informed consent.
- •6. Patient is mentally competent. This is defined by having a score ≥21 on the Folstein
- •Mini-mental State Examination (MMSE) at Screening (Visit 1), and in the opinion of
- •the investigator, she is able to participate in all study required assessments and
- •procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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. Patient has any contraindication to alendronate and vitamin D, including
- •abnormalities of the esophagus which delay esophageal emptying (such as stricture or
- •achalasia), or inability to stand/sit upright for at least 30 minutes, or hypersensitivity
- •to alendronate and vitamin D, or hypocalcemia.
- •2. Patient is not ambulatory. Patient needs assistance for walking and standing-up.
- •3. Patient has abnormal finding or test result in any of physical examination, 12-lead
- •electrocardiogram (ECG) and routine clinical laboratory safety screening tests
- •performed at Screening/Baseline (Visit 1).
- •4. Patient has received treatment with any agent listed below, including:
- •4.1 Any anabolic steroid agent within the past 12 months
- •4.2 Systemic glucocorticoids (≥ 5 mg/day of prednisone or equivalent) for more
- •than 2 weeks in the past 6 months. The exception is over-the-counter topical
- •preparations and inhaled glucocorticoid for the short term treatment of asthma
- •4.3 Oral bisphosphonates (including alendronate, risedronate, etidronate,
- •ibandronate or tiludronate) more than 3 months within the past 2 years; and any
- •0217A, Protocol 262-00 Issue Date: 29-Feb-2008 20
- •Product: MK-0217A 13
- •Protocol/Amendment No.: 262-00
- •0217A_262-00_ProtCore VERSION 16.0 APPROVED 29-Feb-2008
- •Worldwide Restricted Confidential Limited Access
- •lifetime use of an intravenous administration (IV) of zoledronate. The
- •exception is one dose of IV pamidronate or IV ibandronate in more than one
- •year prior to Screening
- •4.4 Immunosuppressant (e.g. cyclosporin, azathioprine). The exception is
- •methotrexate for the treatment of rheumatoid arthritis
- •4.5 Fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks
- •within the past 3 months
- •4.6 Strontium-containing products (more than 200 mg elemental strontium daily,
- •including over-the-counter preparations such as OSTEOVALIN for more
- •than 2 weeks within the past 6 months
- •4.7 Parathyroid hormone [PTH (1-34 or 1-84)] for more than 2 weeks within the
- •past 3 months
- •4.8 Current use of chemotherapy, or heparin
- •4.9 Growth hormone for more than 2 weeks within the past 6 months
- •4.10 Active hormonal vitamin D analogs (e.g., alphacalcidol, calcitriol) in the past 2
- •4.11 Current use of vitamin A (excluding beta carotene) >10,000 IU daily, unless
- •willing to discontinue this dose during the study
- •4.12 Current use of, lithium, or anti-convulsants including barbiturates, hydantoins,
- •and carbamazepine
- •4.13 Current use of calcium supplement in amount excess of 1,500 mg daily, unless
- •willing to discontinue this dose during the study
- •5. Patient has a history of malignancy <5 years prior to signing informed consent.
- •Melanoma, leukemia, lymphoma, and myeloproliferative disorders in any duration
- •and disease stage are not allowed. The exceptions are adequately treated basal cell or
- •squamous cell skin cancer and in situ cervical cancer.
- •6. Patient has one or more of the following concomitant conditions:
- •6.1 Upper gastrointestinal (GI) disorders not adequately controlled (Note: Patients
- •with well-controlled gastro-esophageal reflux disorder (GERD) are allowed to
- •participate in this study.)
- •6.2 Myocardial infarction, unstable angina, stroke and revascularization condition
- 另有 5 项未显示
研究者
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