A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate

MERCK & CO.INC.,0 个研究点目标入组 0 人开始时间: 2009年12月30日最近更新: 2023年9月4日

试验速览

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•Taking oral bisphosphonate treatment for osteoporosis for at least 3 of the past 4 years. At present, and for the past 12 months, treated with alendronate
•Bone Mineral Density (BMD) T-score that is ≤ -1.5 at one or more of the following anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0, AND a history of at least one fragility fracture, OR, a BMD T-score that is ≤ -2.5 at one or more of the following anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0
•Postmenopausal for at least 5 years

•Obesity (ie, weight greater than 250 pounds) that prohibits the use of dual-emission X-ray absorptiometry (DXA)
•Received intravenous (IV) bisphosphonates, fluoride treatment at a dose >1 mg/day for more than 2 weeks, strontium, growth hormone, a cathepsin K (CTSK) inhibitor, or a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor at any time in the past
•Use of oral bisphosphonates other than alendronate in the last 12 months, parathyroid hormone (PTH) in the last 24 months, cyclosporin for more than 2 weeks in the last 6 months, heparin in the last 2 weeks, or anabolic steroids or glucocorticoids for more than 2 weeks in the past 6 months
•Use of estrogen with or without progestin or a selective estrogen receptor modulator (SERM) in the last 6 months or calcitonin in the last 30 days
•Has used pioglitazone hydrochloride or rosiglitazone hydrochloride in the last 6 months
•Taking more than 10,000 International Units (IU) vitamin A daily or more than 5,000 IU vitamin D daily
•Has had a total thyroidectomy
•History of Paget´s disease
•Has human immunodeficiency virus (HIV)
•History of cancer in the last 5 years, except certain skin or cervical cancers
•History of major upper gastrointestinal (GI) mucosal erosive disease
•Unable to adhere to dosing instructions for alendronate in regard to fasting and positioning
•Not ambulatory

发起方

MERCK & CO.INC.,