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25日最近更新: 2012年3月19日

研究概览

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•Consenting postmenopausal women (=5 years since menopause) 45 to 85 years of age, with low bone density who have at screening, an areal BMD T-score that is =-2.5 at one or more of the following 4 BMD 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. 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. The 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.
•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

•The patient has prior use with any agents with action on bone as defined in the protocol. Use of anti-osteoporotic agents during the study (other than the supplied calcium and vitamin D3) is exclusionary. The patient anticipates use of potent inhibitors or potent inducers of CYP3A4. The patient has significant clinical or laboratory abnormalities at the screening visit for the study including but not limited to other metabolic bone disorders, indices of calcium and mineral homeostasis, hepatic, and renal laboratory abnormalities.

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