A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women with Osteoporosis

Merck & Co, Inc.0 个研究点目标入组 384 人开始时间: 2009年6月26日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Merck & Co, Inc.
入组人数: 384

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

•The patient is a woman 45 to 85 years of age, inclusive. Has been postmenopausal for 5 years, defined as no menses for at least 5 years, OR at least 5 years status post bilateral oophorectomy. The patient has no fragility fracture (including any vertebral fracture), documented by medical record, or detected on the screening spine radiographs read locally, unless the patient is unwilling to take, or is not a candidate for marketed osteoporosis therapy. Patient has a BMD T-score <-2.5 at one or more of the following anatomic sites, lumbar spine, femoral neck, trochanter, and total hip, measured at screening by the central imaging vendor, and BMD T-scores = -3.5 at all of these 4 BMD sites, with or without a prior vertebral or non-vertebral fragility fracture. Patient has no increased risk of bone cancer due to any reason, such as a history of skeletal malignancy at any time, or a history of therapeutic irradiation. Patient is not having QCT conducted in this study, or if patient is having QCT conducted in this study she has a body mass index (BMI) that permits CT images of good quality to be obtained (defined as BMI = 35 kg/m2). The patient has a 25-hydroxyvitamin D level 15 ng/mL. During the placebo run-in period, patient took the placebo, calcium supplement (if dispensed during the placebo run-in), and the vitamin D3 supplement, and followed the method of dosing instructions on at least 11 of the 14 days. Patients may also receive vitamin D supplementation prior to alkaline phosphatase and PTH retesting during the screening period (alkaline phosphatase and PTH may be retested once during the screening period)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 and agrees not to use medications for the treatment of osteoporosis
•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

•Patient is unable to have DXA performed due to obesity, defined as weight >250 lbs or >113 Kg. Has received any agents with action on bone including, but not limited to the following (all time periods are relative to Visit 1): IV bisphosphonates (e.g., zoledronic acid), fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks, strontium , growth hormone, any cathepsin K inhibitor, such as MK-0822/odanacatib, use of denosumab or any other RANK-L inhibitor , oral bisphosphonates (use of any oral bisphosphonate in the 6 months prior to screening, use of any oral bisphosphonate for more than 3 months in the prior 2 years, or lifetime use of more than 6 months total), PTH (1-34, or 1-84) at any time within the prior 24 months, cyclosporin for more than 2 weeks within the prior 6 months, heparin within the prior 2 weeks, anabolic steroids or glucocorticoids ( 5 mg/day prednisone or equivalent) for more than 2 weeks in the prior 6 months. Used estrogen ± progestin, raloxifene, tamoxifen, tibolone or another selective estrogen receptor modulator (SERM) within the 6 months prior to Visit 1, or calcitonin within the prior 30 days. Used either pioglitazone hydrochloride, or rosiglitazone maleate, within the 6 months prior to Visit 1. Currently taking vitamin A (excluding beta carotene) >10,000 IU daily, or vitamin D >5,000 IU daily, and is not willing to reduce their vitamin A dose to 10,000 IU daily, and their vitamin D dose to 2000 IU daily. Has primary parathyroid disease, or secondary hyperparathyroidism with an elevated PTH in conjunction with total serum calcium greater than the upper limit of normal (as measured by the central laboratory). Has had prior total thyroidectomy (patient with a hemithyroidectomy may be included. The patient has an abnormal TSH (as measured by the central laboratory). The TSH may be repeated once by the central laboratory during the screening period. Enrollment will be based on the repeat TSH value. If the repeat TSH is upper limit of normal in a subject with known hypothyroidism, she is eligible provided that no change in thyroxine replacement is required. Patients with abnormal TSH who are on thyroid medication (anti-thyroid medication or thyroxine replacement), may be rescreened after the treatment has been adjusted and the patient’s condition has stabilized (defined by a normal TSH at least 6 weeks after the change in medication). Patients with newly diagnosed thyroid conditions are not eligible. Has any history of Paget’s disease of bone. Has an unexplained elevation in alkaline phosphatase or a total serum calcium value or serum PTH value above the upper limit of normal, or an AST (aspartate aminotransferase) or an ALT (alanine aminotransferase) 1.5 times the upper limit of normal. Has hypocalcemia as defined as a total serum calcium <8.5 mg/dL
•Patient anticipates the use of any of the following potent inhibitors or potent inducers of CYP3A4 within 2 weeks prior to starting blinded study medication: grapefruit juice; systemically administered azole antifungals such as ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole; nefazodone; the macrolide antibiotics clarithromycin, dirithromycin, erythromycin, and troleandomycin (Azithromycin use is permitted); protease inhibitors.
•Patients who discontinue these medications, and/or

研究者

发起方

Merck & Co, Inc.

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A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women with OsteoporosisOsteoporosis

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