A BLINDED EXTENSION TO 5 YEARS OF 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

Not Applicable

• Registration Number: PER-086-11
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

1) PATIENT COMPLETED THE BASE STUDY ON BLINDED STUDY THERAPY PNO18 (NOTE THAT AN INTERRUPTION UP TO 6 WEEKS AT END OF THE BASE STUDY IS ACCEPTABLE).
2) PATIENT HAS AT LEAST ONE HIP (eg., CONTAINS NO ELEMENTS FROM ORTHOPEDIC PROCEDURES) AND SUITABLE SPINAL ANATOMY THAT IS EVALUABLE BY DXA.
3) PATIENT UNDERSTANDS THE STUDY PROCEDURES, ALTERNATIVE TREATMENTS AVAILABLE, AND RISK 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 QUESTIONNAIRE IS UNABLE TO COMPLETE THESE WITHOUT ASSISTANCE (eg., to VISUAL PROBLEMS, DIFFICULTY WRITING DUE TO ARTHRITIS, INABILITY TO READ, ETC.) A FAMILY MEMBER OR CARE-GIVER MAY ASSIST OF MAY COMPLETE THE DIARY CARD ON HER BEHALF.

Exclusion Criteria

1) PATIENT HAS A HISTORY OR CURRENT EVIDENCE OF ANY CONDITION, THERAPY. LAB ABNORMALITY OF OTHER CIRCUNSTANCE THAT MUGHT 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 DISCONTINUATION RULES AS DEFINED IN THE BASE STUDY PNO18.
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. CURRENT USE OF LONG-TERM THERAPY (6 MONTHS) WITH ANY STRONG CYP3A4 INDUCERS (eg., RIFAMPIN, PHENOBARBITAL, BARBITURATES, CARBAMAZEPINE, PHENYTOIN, ST. JOHN´S, WORT, NEVIRAPINE, EFAVIRENZ, ETRAVIRINE).
C. CURRENT USE OF SYSTEMATICALLY ADMINISTERED AZOLE ANTIFUNGALS (eg., KETOCONAZOLE, FLUCONAZOLE, ITRACONAZOLE, MICONAZOLE, POSACONOZOLE, RAVUCONAZOLE AND VORICONAZOLE) BECAUSE OF THEIR STRONG INHIBITORY EFFECT ON CYP3A4.

Study & Design

• Study Type: Interventional
• Study Design: Not specified