osteoporosis MedDRA version: 17.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Odanacatib
Product Code: MK-0822
Pharmaceutical Form: Tablet
INN or Proposed INN: Odanacatib
CAS Number: 603139-19-1
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) to assess long-term changes from baseline in total hip bone mineral density (BMD) after 10 years of treatment with odanacatib 50 mg once-weekly in postmenopausal osteoporotic women previously treated with once-weekly odanacatib for at least 5 years (2) to assess safety and tolerability of long-term treatment with odanacatib 50 mg once-weekly. ; Secondary Objective: In postmenopausal women with osteoporosis previously treated with odanacatib 50 mg once-weekly for at least 5 years: (1) To assess long-term changes from baseline in bone mineral density (BMD) of lumbar spine, femoral neck (top of thigh), and trochanter (thigh bone) after 10 years of odanacatib treatment (2) To determine the incidence of morphometrically assessed vertebral fractures during 10 years of odanacatib treatment. Morphometrically assessed fractures are typically crushed vertebrae which are seen on spine X-ray but which generally do not cause any symptoms. (3) To determine the incidence of all clinical fractures during 10 years of odanacatib treatment. In postmenopausal women with osteoporosis previously treated with placebo for at least 5 years and then switched to open-label odanacatib 50 mg once-weekly: (4) To assess changes from baseline in BMD of lumbar spine, total hip, femoral neck, and trochanter during 5 years of odanacatib treatment (5) To determine the inc ;Primary end point(s): Percent change from baseline in total hip bone mineral density (BMD) up to the end of the extension study;Timepoint(s) of evaluation of this end point: At end of study (2019) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At end of study (2019); Secondary end point(s): Percent change from baseline in lumbar spine, femoral neck and trochanter (parts of the hip and thigh) bone mineral density (BMD) up to the end of 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 (fracture detected by and X-ray, rather than by symptoms); Time to first clinical fracture (vertebral and non-vertebral).Vertebral fractures are fractures of the spine whereas non-vertebral fractures are non-spine fractures, For the purposes of this study, non-vertebral fractures exclude fractures of the fingers, toes, face, and skull. | — |
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, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dhome Corp.
Outcome results
None listed