Extension to the Odanacatib Fracture Trial (PN018)

Phase 1

• Conditions: osteoporosis; MedDRA version: 17.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-002587-33-GB
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-02
• Study Completion: 2017-02-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 16071

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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