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

Phase 1

• Conditions: Postmenopausal Osteoporosis; MedDRA version: 17.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2007-002693-66-EE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-26
• Last Update Posted: 19 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 8254

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified