E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal Osteoporosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017082 |
E.1.2 | Term | Fracture due to osteoporosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031285 |
E.1.2 | Term | Osteoporosis postmenopausal |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Volumetric trabecular bone mineral density |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
This is a sub-study to Protocol 0822-018 |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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This is an event-driven trial, which will end when the required number of fractures to test the hypotheses have occurred. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |