An Open-Label 5-Year 2nd Extension to: A Phase III 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 - Open-Label Extension to the Odanacatib Fracture Trial (PN018)

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 16,071 人开始时间: 2014年12月2日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•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.
•4. Have at least one hip (e.g., contains no hardware from orthopedic procedures) AND
•suitable spinal anatomy that is evaluable by DXA.
•5. Understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agree to participate by providing informed consent.
•6. Be able to read, understand and complete questionnaires and diaries.
•7. Be in generally good health, based on medical history, physical examination, and
•laboratory evaluation.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5000

•The subject must be excluded from participating in the trial if the subject:
•1. 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 subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
•2. Is receiving treatment as follows:
•1) 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.)
•2) 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).
•3. 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.
•4. Has participated in an investigational drug study other than the base study or 1st extension study within the past 30 days.
•5. Is currently a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.

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