EUCTR2007-002693-66-GB进行中（未招募）1 期
A Blinded Extension to 5 Years of a Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of MK-0822 to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co.0 个研究点目标入组 16,071 人开始时间: 2007年10月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16,071
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
入选标准
- •1.Patient is a woman and is = 65 years of age on the day of randomisation.
- •2.Patient meets one of the following:
- •a)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score =-1.5 at either the total hip or femoral neck site, BMD T-score =-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – OR-
- •b)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score =-2.5 at either the total hip or femoral neck site, BMD T-score =-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – OR -
- •c)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score =-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – OR-
- •d)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score =-2.5 at either the total hip or femoral neck site and does not havea prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%).
- •3.The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
- •4.Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
- •5. Patient completed the base study on blinded therapy PN018 (note that interruption up to 6 weeks at the end of the base study is acceptable
- •6. Patient understands the study procedures, alternative treatments available and risks involved with the study and voluntarily agrees to participate by providing informed consent
- •7. Patient/Subject is able to read, understand and complete questionnaires and diaries
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 925
排除标准
- •In addition to the exclusion criteria defined in the original submission:
- •1)Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- •2)Patient met excessive bone loss criteria as defined in the base study.
- •3)Patient met any of the discontinuation rules as defined in the base study PN018.
- •4)Patient is receiving treatment with:
- •a.Current use of osteoporosis therapy including: bisphosphonates, PTH, strontium, systemic estrogen + progestin, raloxifene or other SERM, RANK ligand inhibitor, or sub-cutaneous calcitonin. (Note: use of intranasal calcitonin is permitted.)
- •b.Current use of long-term therapy (6 months) with any strong CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St. John’s wort).
研究者
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