Postmenopausal Osteoporosis MedDRA version: 14.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Sponsors
MERCK SHARP & DOHME CORP.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is a woman and is = 65 years of age on the day of signing informed consent. 2. Patient meets one of the following: a) Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score =-1.5 at either the total hip or femoral neck site, BMD T-score =-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – ORb) Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score =-2.5 at either the total hip or femoral neck site, BMD T-score =-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – OR - c) Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score =-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – ORd) Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score =-2.5 at either the total hip or femoral neck site. 3. The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures). 4. Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy. 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 16300
Exclusion criteria
Exclusion criteria: 1) Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture. 2) Patient has had a prior hip fracture. 3) Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.) 4) Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH). 5) Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of treatment with MK-0822 50 mg once weekly on the risk of morphometrically assessed vertebral fractures compared to placebo. To assess the effect of treatment with MK-0822 on the risk of hip fractures compared to placebo. To assess the effect of treatment with MK-0822 on the risk of clinical non-vertebral fractures compared to placebo. (Note: for the purposes of this study, non-vertebral fractures are defined as fractures of the hip, pelvis, wrist, humerus, clavicle, leg and rib).;Secondary Objective: To assess the effect of treatment with MK-0822 50 mg once weekly: on the risk of clinical vertebral fractures compared to placebo. on height compared to placebo. on the lumbar spine, total hip, femoral neck, trochanter and distal forearm BMD compared to placebo. on biochemical indices of bone resorption (serum C-Telopeptides of Type 1 collagen [s-CTX] and urine NTelopeptides of Type 1 collagen [u-NTX]) compared to placebo.To assess the effect of treatment with MK-0822 50 mg once weekly on biochemical indices of bone formation (serum bone-specific alkaline phosphatase [BSAP] and serum-P1NP) compared to placebo. on qualitative histomorphometry of transilial bone biopsy specimens compared to placebo. To assess the safety and tolerability of treatment with MK-0822 50 mg once weekly compared to placebo.;Primary end point(s): Morphometric fractures, hip fractures, and clinical non-vertebral fractures.;Timepoint(s) of evaluation of this end point: At baseline, Month 6, Month 12, and yearly thereafter until the end of the 5-year doubleblind extension study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Bone Mineral Density 2) Clinical non-vertebral and vertebral Fracture evaluation;Timepoint(s) of evaluation of this end point: At baseline and each of the yearly timepoints up to the end of the extension study | — |
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, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Department
UAB "Merck Sharp & Dohme"
Outcome results
None listed