low BMD (bone mineral density) MedDRA version: 9.1 Level: LLT Classification code 10032364 Term: Other osteoporosis
Conditions
Interventions
Chemical name: N1-(1-cyanocyclopropyl)-4-fluoro-N2-{(1S)-2,2,2-trifluoro-1-[4’-(methylsulfo
Product Code: MK-0822
Pharmaceutical Form: Tablet
INN or Proposed INN: odanacatib
CAS Number: 603139-19-1
Co
Sponsors
Merck Sharp & DOhme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is 45-85 years of age on the day of Randomization. 2. Patient has been postmenopausal for at least 3 years, defined as no menses for at least 3 years OR at least 3 years status post bilateral oophorectomy. 3. Patient has a BMD t-Score at the total hip, hip trochanter, femoral neck or lumbar spine =–1.5 but >–3.5. 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. The investigator believes that the patient is at sufficiently high risk for osteoporotic fracture within the next 24 months such that randomization to placebo would be unacceptable (e.g. patient has a BMD t-Score of <-3.5 AND history of low-dose glucocorticoid use). 2. Patient has had a previous hip fracture at any time. 3. Patient has experienced a non-hip clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: finger, toe and skull fractures are not considered with regard to this exclusion criterion) 4. Patient has had more than 1 prior clinical vertebral fracture and she is a suitable candidate for osteoporosis therapy. (i.e. bisphosphonates, strontium, or PTH). 5. Patient has chosen treatment with oral bisphosponates or other agents demonstrated to reduce the risk of hip fracture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: In postmenopausal women with low BMD: (1) Objective: To evaluate at 24 months the effect of treatment with MK-0822 50 mg OW on aBMD at the lumbar spine (assessed by DXA) compared to placebo (2) Objective: To evaluate at 12 and 24 months the effect of treatment with MK-08 22 50 mg OW on aBMD at the total hip, femoral neck, hip trochanter and one-third distal forearm (assessed by DXA) compared to placebo (3) Objective: To estimate at 12 and 24 months the effect of treatment with MK-0822 50 mg OW on trabecular volumetric BMD (vBMD) at the lumbar spine (assessed by QCT) (4) Objective: To estimate at 12 and 24 months the effect of treatment with MK-0822 50 mg OW in biochemical indices of bone formation (s-P1NP) and bone resorption (s-CTx) ;Primary end point(s): Areal BMD at the lumbar spine (at 12 months);Main Objective: In postmenopausal women with low BMD: Objective: To evaluate at 12 months the effect of treatment with MK-0822 50 mg OW on areal BMD (aBMD) at the lumbar spine (assessed by DXA) compared to placebo Objective: To assess at 12 and 24 months the safety and tolerability of treatment with MK-0822 50 mg OW compared to placebo | — |
Countries
Denmark, France, Germany, Sweden
Outcome results
None listed