A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled,Dose-Range-Finding Study to Evaluate the Effects of MK5442 on BoneMineral Density (BMD) in the Treatment of Osteoporosis inPostmenopausal Women Previously Treated With an Oral Bisphosphonate

Merck Sharp and Dohme0 个研究点目标入组 526 人开始时间: 待定最近更新: 2021年11月24日

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•Patient has been taking an oral bisphosphonate for osteoporosis for at least 3 years within the past 4 years, and the bisphosphonate must have been alendronate for the most recent 12 months, and is currently taking alendronate.
•Patient has a BMD T-score that is less than or equal to -1.5 at one or more of the following 4 BMD sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is greater than or equal to -4.0, AND a history of at least one fragility fracture, OR, an aBMD T-score that is less than or equal to -2.5 at one or more of the following 4 BMD sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is greater than or equal to -4.0
•Patient has been postmenopausal for at least 5 years

•- Is unable to have dual-emission X-ray absorptiometry (DXA) performed due to obesity
•- Has received intravenous (IV) bisphosphonates, fluoride treatment at a dose 1 mg/day for more than 2 weeks, strontium, growth hormone, a cathepsin K inhibitor, or a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor at any time in the past
•- Has received 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
•- Has used 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
•- Is taking more than 10,000 IU vitamin A daily or more than 5,000 IU vitamin D daily
•- Has had a total thyroidectomy
•- Has any history of Pagets disease
•- Is HIV positive
•- Has a history of cancer in the last 5 years, except certain skin or cervical cancers
•- Has a history of major upper gastrointestinal mucosal erosive disease
•- Is unable to adhere to dosing instructions for alendronate in regard to fasting and positioning
•- Is not ambulatory

发起方

Merck Sharp and Dohme