The Efficacy and Safety of BHH10 in Patients with Osteoporosis : a Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial

Hanpoong Pharm & Foods0 个研究点目标入组 168 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Ambulatory females aged 55 to 85 years
•2. Postmenopausal women (at least 12 months after last menstrual period)
•3. Bone mineral density = -2.5 standard deviation (SD)
•4. Subject who decide to participate in clinical trials and signed a consent form after providing with detailed explanation

•1. Serum alkaline phosphatase > 2 times of upper limit of normal range
•2. Subject who has liver disease (AST or ALT > 2 times of upper limit of normal range)
•3. Subject who has kidney disease (serum creatinine > 2.0 mg/dl)
•4. Hypercalcemia (Ca > 10.5 mg/dl)
•5. Subject who has uncontrolled chronic disorders that may affect bone metabolism (For example, chronic liver disease, alcoholism, primary hyperparathyroidism, malignant tumor etc.)
•6. Subject who took pharmacotherapy (except calcium and vitamin D) for osteoporosis within 3 months
•7. Subject who took injection therapy for osteoporosis within 6 months
•8. Subject who took drugs that may affect calcium metabolism in bones for more than 6 months (For example, systematic steroids, diuretics etc.) (However, it is possible to participate subjects who did not take banned drugs except anticonceptive injection within the last 3 months before screening)
•9. Subject with metabolic bone disease except osteoporosis
•10. Subject with mental disorders who cannot follow compliance details of clinical trials

发起方

Hanpoong Pharm & Foods