Postmenopausal Osteoporosis MedDRA version: 17.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectives 1st extension: 1. To assess the effect of treatment up to 5 years with odanacatib on the risk of morphometrically assessed vertebral fractures compared to placebo. 2. To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo. Obejctives 2nd extension: In postmenopausal women with osteoporosis randomized to odanacatib 50 mg once-weekly in the base study and continuing on odanacatib during base and both extension periods: To assess change from baseline in total hip BMD after 10 years of treatment. To assess safety and tolerability of long-term treatment;Secondary Objective: 1st extension (E) To assess effect of treatment up to 5 years with odanacatib 50 mg once weekly: on the lumbar spine, total hip, femoral neck, and trochanter BMD vs. placebo on the risk of all clinical fractures vs. placebo on the risk of non-vertebral clinical fractures vs. placebo 2nd E In POM women randomised to odanacatib in base study (BS) and continuing on odanacatib during both E periods, after 10 years: assess change from baseline (randomisation in BS) in BMD of lumbar spine, femoral neck, trochanter determine incidence of morphometrically assessed vertebral fractures, all clinical fractures In POM women with osteoporosis treated with placebo for 5 years (BS, 1st E study) and switched to odanacatib in 2nd E, during 5 years of treatment with odanacatib: assess changes from baseline (start of open-label period) in BMD of lumbar spine, total hip, femoral neck, trochanter determine the incidence of morphometrically assessed vertebral fractures, all clinical fractures;Primary end point(s): 1st extension: 1. Morphometric vertebral fractures 2. Morphometric clinical hip and non-vertebral fractures 2. Evaluation of Adverse Reactions 2nd extension: In subjects randomized to odanacatib 50 mg OW in the base study and continuing on odanacatib in the extension: 1. Percent change from baseline in total hip BMD | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1st extension: 1. Bone Mineral Density 2. Clinical non-vertebral and vertebral Fracture evaluation 2nd extension: In subjects randomized to odanacatib 50 mg OW in the base study and continuing on odanacatib in the extension: - Percent change from baseline in total hip BMD at all other time points up to the end of the extension study - Percent change from baseline in lumbar spine, femoral neck and trochanter BMD at each time point up to the end of the extension study - Time to first morphometric fracture - Time to first clinical fracture (vertebral and non-vertebral) In subjects randomized to placebo in the base study and continuing on odanacatib in the extension: - Percent change from start of open-label (Year 6) in lumbar spine, total hip, femoral neck and trochanter BMD up to the end of the extension study - Time to first morphometric fracture - Time to first clinical fracture (vertebral and non-vertebral) ;Timepoint(s) of evaluation of this end point: 1st extension: At baseline and each of yearly timepoints up to the end of the extension study 2nd extension: 1. From baseline until end of study: For subject with an allocation number (AN) ending with an odd number - at screening, month 72, month 96, month 120, month 144 and end of study visits. For subjects with an AN ending with an even number - at screening, month 84, month 108, month 132 and end of study visits 2 - From the start of open-label period (Year 6) until end of study: For subject with an AN ending with an odd number - month 72, month 96, month 120, month 144 and end of study visits. For subjects with an AN ending with an even number - month 84, month 108, month 132 and end of study visits 3 - The time from the start of open-label treatment to first fracture | — |
Countries
Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Dominican Republic, Guatemala, Hong Kong, India, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, New Zealand, Norway, Peru, Philippines, Russian Federation, Serbia, South Africa, Switzerland, Taiwan, Ukraine, United States
Contacts
Public ContactGCTO Lithuania
UAB "Merck Sharp & Dohme"
Outcome results
None listed