EUCTR2011-005514-10-LT进行中（未招募）1 期
A 2nd Open-Label Extension for 5 Years to: The Placebo-Controlled 1st Extension to a Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - N.A.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 8,254 人开始时间: 2011年12月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8,254
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
- 性别
- Female
入选标准
- •1st and 2nd extension:
- •1. Patient completed the base study on blinded study therapy PN018 (Note that an interruption up to 6 weeks at end of the base study is acceptable).
- •2. Patient has at least one hip (e.g. contains no hardware from orthopedic procedures) and suitable spinal anatomy that is evaluable by DXA.
- •3. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by providing informed consent.
- •4. Patient/subject is able to read, understand and complete questionnaires and diaries.
- •Note: If a patient who understands the purpose and use of the diary cards and study questionnaires is unable to complete these without assistance (e.g. due to visual problems, difficulty writing due to arthritis, inability to read, etc.), a family member or care-giver may assist or may complete the diary card on her behalf.
- •2nd extension:
- •In order to be eligible for participation in this trial, the subject must:
- •1. Have met all initial inclusion criteria and have not met any of the exclusion or discontinuation criteria of either the base or 1st extension studies
- •2.Be an active participant and have successfully completed the 1st extension study on study medication. (Note: An interruption of approximately 12 weeks from the end of 1st extension study to the beginning of 2nd extension study is permissible).
- •3. Be assessed by the investigator as having had appropriate compliance during the base and 1st extension studies.
- •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 8254
排除标准
- •1st and 2nd extension:
- •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. Subject is planning to initiate or is currently using long-term therapy (6 weeks or longer) with any CYP3A4 inducers (see Appendix 12.5 for examples).
- •2nd extension:
- •1. Is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the subject cannot read or comprehend the written material.
- •2. Has participated in an investigational drug study other than the base study or 1st extension study within the past 30 days.
- •3. Is currently a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
研究者
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已完成
不适用
A 5-YEAR OPEN LABEL EXTENSION TO: A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND EFFICACY OF ODANACATIB (MK-0822) IN THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSISPER-075-10MERCK SHARP & DOHME PERU S.R.L.,3