E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We want to investigate if rosiglitazone treatment can induce bone loss in humans |
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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 | 10031289 |
E.1.2 | Term | Osteoporosis, unspecified |
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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 |
To investigate if 14 weeks of rosiglitazone treatment can induce bone loss, as evaluated by DXA-scans |
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E.2.2 | Secondary objectives of the trial |
- To investigate the effect on bone turnover by measuring biochemical markers of bone turnover in blood and urine before and after treatment. - To investigate the effect on the expression of osteoblast- and adipocyte-specifik markers in bone marrow. - To investigate the effect on geneekspression in preosteoblasts and adipocytes from bone marrow and adipocytes from subcutaneous adipose tissue. - To investigate the effect on bone marrow fat content and peripheral fat distribution as measured by MR_scans. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Female -Postmenopausal as defined by 2 years menopause -Age 60-75 -Informed conscent |
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E.4 | Principal exclusion criteria |
-Osteoporosis (T-score<-2,5 in hip or lumbar spine or previous low impact fractures except fracture of fingers, toes, face, ribs, clavicle) -Endocrinological disease -Treatment with bone active drugs: Hormone replacement therapy within last two years, antiosteoporotic treatment, peroral or intravenous corticosteroidhormone treatment equivalent to more than 1g of prednisolone within last year, antidiabetic treatment. -Congestive or ischaemic heart disease -Ongoin malignant disease or malignant disease within last 5 years except basocellular carcinoma of the skin. -Anaemia 8p-hemoglobin < lower normal level) -Renal disease (p-creatinine > upper normal level) -Liver disease (transaminases > 2 x upper normal level, alkaline phosphatase > upper normal level)
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate if 14 weeks of rosiglitazone treatment can induce bone loss, as evaluated by DXA-scans |
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |