Postmenopausal Osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10017082 Term: Fracture due to osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is already enrolled in Protocol 018. 2. Participant is willing to undergo all imaging procedures and bone biopsies. 3. Participant has two hips that are evaluable by DXA and QCT (e.g., contain no hardware from orthopedic procedures). 4. Participant has a spinal anatomy suitable for DXA and QCT of the lumbar spine. Significant scoliosis, bone deformity, and sequelae of orthopedic procedures that result in unsuitable anatomy must be absent from the lumbar spine. At least two vertebrae from L1-L4 must be evaluable. 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
Exclusion criteria
Exclusion criteria: 1. Participant has a history of tremors, Parkinson's disease, multiple sclerosis or other diseases that cause persistent tremors. 2. Participant is unable to take a bone-labeling agent (e.g., demeclocycline or tetracycline). 3. Participant has a past medical history of clotting or bleeding disorders. 4. Participant is unlikely to adhere to the study procedures or keep appointments, or is planning to relocate during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: In postmenopausal women with osteoporosis: 1. To estimate the effect of treatment with MK-0822 50 mg OW on volumetric cortical bone mineral density (vBMD) at the hip (assessed by QCT) at Month 12, Month 24, and end of study. 2. To evaluate the effect of treatment with MK-0822 50 mg OW on the percent change from baseline in aBMD at the lumbar spine, hip and hip sub-regions and 1/3 distal forearm (assessed by DXA) at Month 12, Month 24, and end of study. 3. To evaluate the effect of treatment with MK-0822 50 mg OW on the percent change in biochemical indices of bone formation [serum-bone specific alkaline phosphatase (s-BSAP) and serum N-terminal propeptides of Type I collagen (s-P1NP)] and bone resorption [serum C-telopeptides of Type I collagen (s-CTx) and urinary N telopeptides of Type I collagen (u-NTx)] at Month 12, Month 24, and end of study.;Main Objective: In postmenopausal women with osteoporosis: To estimate the effect of treatment with MK-0822 50 mg once weekly (OW) on volumetric trabecular bone mineral density (vBMD) at the lumbar spine (assessed by QCT) at Month 12, Month 24, and end of study. ;Primary end point(s): Volumetric trabecular bone mineral density | — |
Countries
Czech Republic, Denmark, Estonia
Outcome results
None listed