Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safetyof MK-0217A/Alendronate Sodium 70 mg/Vitamin D3 5600 I.U.Combination Tablet on Vitamin D Inadequacy in the Treatment ofOsteoporosis in Postmenopausal Women

MSD0 个研究点目标入组 500 人开始时间: 2008年4月4日最近更新: 2012年5月1日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: MSD
入组人数: 500

研究概览入排标准研究者记录与标识符相似试验

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. 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:
•a) Patient has BMD T-score = -2.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck, OR
•b) 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,
•Note: Eligibility for this criterion is based on absolute BMD in g/cm2 as follows: Total hip T-scores of -1.5 and -2.5 correspond to 0.759 and 0.637 for Hologic machines; 0.820 and 0.694 for GE Lunar machines, and 0.736 and 0.614 for Norland machines. Femoral neck T-scores of -1.5 and -2.5 correspond to 0.678 and 0.558 for Hologic machines; 0.830 and 0.691 for GE Lunar machines, and 0.762 and 0.629 for Norland machines. Lumbar spine T-scores of -1.5 and -2.5 at L1 to L4 correspond to 0.882 and 0.772 for Hologic machines, 1.000 and 0.880 for GE Lunar machines, and 0.848 and 0.689 for Norland machines.
•Note: A fragility fracture is defined as a fracture that occurred with minimal trauma that would be unlikely to cause fracture in a non-osteoporotic adult. This assessment is made by the study investigator.
•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:
•a) 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.
•b) Reduced lower extremity physical function. This is defined by having a summary score between 4 and 9 on SPPB at Screening (Visit 1).
•c) 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). This criterion should be based on the most recent 25(OH)D analysis reported prior to visit 2.
•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’s Min-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:
•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
•2. Patient is not ambulatory. Patient needs assistance for walking and standing-up.
•3. Patient has significant unexplained 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:
•a) any anabolic steroid agent within the past 12 months
•b) 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
•c) oral bisphosphonates (including alendronate, risedronate, etidronate, ibandronate or tiludronate) more than 3 months within the past 2 years; and any 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
•d) immunosuppressant (e.g. cyclosporin, azathioprine). The exception is methotrexate for the treatment of rheumatoid arthritis
•e) fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months
•f) 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
•g) Parathyroid hormone [PTH (1-34 or 1-84)] for more than 2 weeks within the past 3 months
•h) current use of chemotherapy, or heparin
•i) growth hormone for more than 2 weeks within the past 6 months
•j) active hormonal vitamin D analogs (e.g., alphacalcidol, calcitriol) in the past 2 months
•k) current use of vitamin A (excluding beta carotene) >10,000 IU daily, unless willing to discontinue this dose during the study
•l) current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine
•m) 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.
•6. Patient has one or more of the following concomitant conditions:
•a) upper gastrointestinal (GI) disorders not adequately controlled
•b) myocardial infarction, unstable angina, stroke and revascularization condition within 3 months
•c) malabsorption syndrome
•d) primary or secondary hyperparathyroidism not adequately controlled
•e) thyroid disease not adequately controlled
•f) renal insufficiency not adequately controlled. This is defined as serum-creatinine >1.6 mg/dL and calculated* creatinine clearance = 30 mL/min (Cockroft and Gault method)
•g) uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; unexplained laboratory test abnormality or other conditions that, in the opinion of the investigator, may suggest a high risk to the patient, impair the patient’s ability to complete the trial or confound study results
•h) uncontrolled hypertension
•i) new onset diabetes (within 3 months), poorly controlled hyperglycemia (e.g. Hb A1c >8.5%), hypoglycemia for any cause (e.g. blood glucose < 50 mg/dL)
•j) history of, or evidence for metabolic bone disease other than osteoporosis (e.g. Paget’s disease or osteomalacia)
•k) abnormal indices of calcium metabolism
•l) active renal

研究者

发起方

MSD

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