Osteoporosis MedDRA version: 16.0 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: MK-0822
Pharmaceutical Form: Tablet
CAS Number: 603139-19-1
Current Sponsor code: MK-0822
Other descriptive name: Odanacat
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible for participation in this trial, the subject must: 1. Have been randomized into Protocol 018 2. Have taken at least 1 dose of blinded study medication 3. Have discontinued from Protocol 018 base study prior to study close-out OR have completed the base study of Protocol 018 and did not continue into the 1st extension of Protocol 018 OR have discontinued the 1st extension study (Protocol 018-10/Protocol 018-05) prior to reaching the open-label portion of the study OR have discontinued the amended 1st extension study (Protocol 018-06) prior to reaching the open-label period of the study and did not consent to continue follow-up clinic visits and study procedures. 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 6000
Exclusion criteria
Exclusion criteria: The subject must be excluded from participating in the trial if the subject: 1. Had her Protocol 018 treatment group assignment unblinded, prior to the open-label period 2. Has discontinued treatment after she entered into the open-label period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect and assess safety information for the double-blinded treatment period ending 5 years post-randomization regarding deaths, SAEs, adverse events requiring adjudication, and skin ECIs in subjects who were randomized and tookat least one dose of blinded study medication, then discontinued from study drug but have not completed follow-up through the 5-year blinded treatment period of Protocol 018 and its 1stextension. These data will be analyzed togetherwithdata fromsubjects who have completed 5 years of blinded study medication;Secondary Objective: not applicable;Primary end point(s): Safety analyses will be performed for he events collected in this study, namely skin events reported as ECIs, serious respiratory infections confirmed by adjudication, osteonecrosis of the jaw confirmed by adjudication, morphea or systemic sclerosis confirmed by adjudication and delayed fracture unions confirmed by adjudication (Tier-1 events in Protocol 018), as well as the other events confirmed by adjudication (atypical femoral shaft fractures, and cerebrovascular or cardiovascular events) and mortality and serious adverse eventsThe overall trial ends when the last subject’s reportable event has either resolved or met stabilization criteria (see flowchart footnote 7) after all reportable events have been collected at Month 60 or has been lost to follow-up (i.e. the subject is unable to be contacted by the investigator).;Timepoint(s) of evaluation of this end point: Month 48 and Month 60 after randomization into the main Protocol 018 base study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Mexico, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia S.r.l.
Outcome results
None listed