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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2008-004578-42-CZ |
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Date of registration:
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21/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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21/10/2009 |
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Target sample size:
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25 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004578-42 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Denmark
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Estonia
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Participant is already enrolled in Protocol 018.
2. Participant is willing to undergo all QCT and DXA imaging procedures and biomarker assessments.
3. Participant's body habitus allows for QCT scanning (i.e. Body Mass Index (BMI) is = 35 kg/m2).
4. Participant has two hips that are evaluable by DXA and QCT (e.g., contain no hardware from orthopedic procedures). Note: Surgical clips are acceptable.5. Participant has a spinal anatomy suitable for DXA and QCT of the lumbar spine. (e.g. does not have significant scoliosis, bone deformity, hardware or sequelae of orthopedic procedures. Note: Surgical clips are acceptable.) For DXA, at least 2 vertebrae from L1-L4 must be evaluable and for QCT, at least 2 vertebrae from T12-L3 must be evaluable.
6. Participant understands the study procedures and the risks involved with the study and voluntarily agrees to participate by giving written informed consent.
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 unlikely to adhere to the study procedures or keep appointments, or is planning to relocate during the study.
3. Participant baseline QCT imaging scan, of the hip or spine, is of insufficient quality, as confirmed by the central imaging vendor.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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Product Name: MK-0822; 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
Current Sponsor code: MK-0822
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: cholecalciferol (Vitamin D3)
Pharmaceutical Form: Tablet
INN or Proposed INN: cholecalciferol
CAS Number: 67-97-0
Other descriptive name: Vitamin D3
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2800-
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Primary Outcome(s)
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Main Objective: In postmenopausal women with osteoporosis:
To evaluate the effect of treatment with MK-0822 50 mg once weekly (OW) on the percent change from baseline in trabecular volumetric bone mineral density (vBMD) at the lumbar spine (assessed by QCT) compared to placebo at Month 24.
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Secondary Objective: In postmenopausal women with osteoporosis:
1. To evaluate the effect of treatment with MK-0822 50 mg OW on the percent change from baseline in cortical vBMD at the hip (assessed by QCT) compared to placebo at Month 24.
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) compared to placebo at Month 24.
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)] compared to placebo at Month 24.
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Primary end point(s): Volumetric trabecular bone mineral density
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Secondary ID(s)
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0822-032
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2008-004578-42-DK
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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