osteoporosis MedDRA version: 12.1 Level: LLT Classification code 10031282 Term: Osteoporosis
Conditions
Interventions
Product Name: Odanacatib
Product Code: MK-0822
Pharmaceutical Form: Tablet
CAS Number: 603139-19-1
Current Sponsor code: MK-0822
Sponsors
Merck Sharp & Dohm Corp.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Male between 40 and 95 years of age; (2) Patient has idiopathic osteoporosis or osteoporosis due to hypogonadism and fulfils one of the following BMD critieria: (a) patient is a candidate for osteoporosis therapy and has BMD T-score = - 2.5 at either the lumbar spine (LS) or the total hip or any hip subregion (femoral neck or trochanter) and a BMD T-score = - 4.0 at all sites and does not have a prior vertebral fracture (b) patient is a candidate for osteoporosis therapy and has BMD T-score = - 1.5 at either the LS or the total hip or any hip subregion (femoral neck or trochanter) and a BMD T-score = - 4.0 at all sites and has one prior vertebral fracture OR (c) patient is not a candidate for, or has declined osteoporosis therapy and has BMD T-score = - 2.5 at either the LS or the total hip or any hip subregion (femoral neck or trochanter) and does not have a prior vertebral fracture; or has BMD T-score = - 1.5 at either the LS or the total hip or any hip subregion (femoral neck or trochanter), and has at least one prior vertebral fracture; (3) Patient has lumbar spine anatomy suitable for DXA. Specifically, at least 2 vertebral bodies in the L1 to L4 region must be assessable; (4) Patient is ambulatory. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria
Exclusion criteria: (1) Patient has chosen treatment with oral bisphosphonates or other agents for the treatment of osteoporosis (2) Patient has a prior fragility hip fracture and is a suitable candidate for osteoporosis therapy ( i.e., bisphosphonates, parathyroid hormone (PTH) ); (3) Patient has experienced a fragility fracture (including any vertebral fracture) within 12 months, documented by medical record, or detected on the screening spine radiographs read locally, unless the patient is unwilling to take, or is not a candidate for marketed osteoporosis therapy (4) Patient has had more than 1 prior vertebral fracture and he is a suitable candidate for osteoporosis therapy (5) Patient has evidence of a metabolic bone disorder other than osteoporosis (6) Patient has vitamin D deficiency, defined as serum 25-hydroxyvitamin D 1.6 mg/dL and is considered to have severe renal insufficiency(12) Patient has a history of malignancy = 5 years prior to signing of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: (1) To describe the safety and tolerability of treatment with odanacatib 50mg once weekly compared to placebo over 24 months; (2) To assess the effect of treatment with odanacatib 50mg once weekly on the total hip, femoral neck, and trochanter BMD compared to placebo over 24 months; (3) To assess the effect of treatment with odanacatib 50mg once weekly on biochemical indices of bone resorption compared to placebo over 24 months; To assess the effect of treatment with odanacatib 50mg once weekly on biochemical indices of bone formation compared to placebo over 24 months; (4) To assess the effect of treatment with odanacatib 50mg once weekly on the lumbar spine, total hip, femoral neck, and trochanter BMD compared to placebo over 36 months; (5) To assess the effect of treatment with odanacatib 50mg once weekly on biochemical indices of bone resorption; and on biochemical indices of bone formation compared to placebo over 36 months; Main Objective: (1) To assess the effect of odanacatib 50 mg once weekly versus placebo on lumbar spine BMD over 24 months; (2)To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo. ;Primary end point(s): BMD percent change from baseline at lumbar spine at Month 24 | — |
Countries
Bulgaria, Denmark, Estonia, Italy, Latvia, Netherlands, United Kingdom
Outcome results
None listed