An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - The Imaging Sub-study for the Fracture Trial

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-004578-42-EE
• Date of registration: 27/10/2009
• Prospective Registration: Yes
• Primary sponsor: Merck & Co., Inc.
• Public title: An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - The Imaging Sub-study for the Fracture Trial
• Scientific title: An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - The Imaging Sub-study for the Fracture Trial
• Date of first enrolment: 11/11/2009
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004578-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: This is a sub-study to Protocol 0822-018 If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Denmark, Estonia

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Pharmaceutical Form:

Primary Outcome(s)

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.

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.

Primary end point(s): Volumetric trabecular bone mineral density

Secondary ID(s)

0822-032

2008-004578-42-DK