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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To explore the relationship between baseline bone strength at the lumbar spine, estimated from QCT-based finite element analysis, and the risk of vertebral fractures. 2. To explore the relationship between baseline bone strength at the hip, estimated from QCT-based finite element analysis, and the risk of non-vertebral (including hip) fractures.
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E.2.2 | Secondary objectives of the trial |
1. To explore the relationship between changes in bone strength at the lumbar spine, estimated from QCT-based finite element analysis, and the risk of vertebral fractures. 2. To explore the relationship between changes in bone strength at the hip, estimated from QCT-based finite element analysis, and the risk of non-vertebral fractures (including hip).
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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 QCT imaging procedures. 3. Participant's Body Mass Index (BMI) is ≤ 35 kg/m2 4. Participant has a spinal anatomy that is suitable for QCT of the lumbar spine from T12 through L3 (e.g. does not have significant scoliosis, bone deformity, hardware or sequelae of orthopedic procedures. Note: Surgical clips are acceptable.) 5. Participant has two hips that are evaluable by QCT (e.g., contain no hardware from orthopedic procedures). Note: Surgical clips are acceptable.
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E.4 | Principal exclusion criteria |
1. Participant has a history of tremors, or other movement disorder that may interfere with imaging by QCT. 2. Participant has any metallic hardware in the abdomen or pelvis, such as orthopedic implants, that may interfere with imaging of the hip or spine by QCT. 3. 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) |
Trabecular Volumetric Bone Mineral Density (vBMD), Trabecular Volume, Cortical vBMD and Cortical Volume of the lumbar spine and hip. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 |
Sub-study of Protocol mk-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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Trial will end when Protocol mk-0822-018 ends and PN 018 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 | |
E.8.9.2 | In all countries concerned by the trial years | 5 |