/A
- Conditions
- Postmenopausal OsteoporosisMedDRA version: 18.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2007-002693-66-BG
- Lead Sponsor
- Merck Sharpe & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 16071
Second extension
In order to be eligible for participation in this trial, the subject must:
NOTE: Subjects inappropriately randomized into the trial (i.e., those who do not meet entry criteria) may be discontinued from the study at the discretion of the Sponsor.
1. Have met all initial inclusion criteria and ha ve not met any of the exclusion or discontinuation criteria of either the base or 1st extension studies.
NOTE: There is no specific BMD T-score required for eligibility in this extension study. If a subject has met excessive bone loss criteria at her end of study visit for the
1st extension study, or the 2nd extension screening visit, she can continue into this 2nd extension.
2. Be an active participant and have successfully completed the 1st extension study on study medication. (An interruption of approximately 12 weeks from the end of the first extension study to the begining of 2nd extension study is permissible).
3. Be assessed by the investigator as having had appropirate compliance during the base and 1st extension studies.
4. Have at least one hip (e.g. contains no hardware from or thopedic 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. NOTE: If a subject 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
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:
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 5000
Second extension:
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 bes t 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method