E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of postmenopausal osteoporosis to reduce the risk of hip and vertebral fractures [Osteoporotic fracture] |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031290 |
|
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 |
The aim of the study is to evaluate the adherence to Protelos2g: the compliance with the treatment (the percentage of doses taken) and the persistence on the treatment (the number of days until discontinuation, the evaluation of proportion of patients continuing treatment during treatment period, the treatment satisfaction questioning), the improvement of the quality of life including back pain (assessed by the visual analogue scale questioning) in patients suffering from postmenopausal osteoporosis taking Protelos2g. |
|
E.2.2 | Secondary objectives of the trial |
The secondary aim is to demonstrate the acceptability of Protelos2g (adverse drug reactions, BMI, blood pressure and heart rate, patient's questions using VAS), the clinical efficacy (relative change in lumbar spine and total hip BMD from baseline assessed by dual energy X-ray Absorptiometry, DXA). |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The main inclusion criteria will be: (1) female adults at least 50 years of age, (2) postmenopausal for at least 5 years, (3) newly diagnosed patients, not treated with any antiosteoporotic drug for certain period before the inclusion, (4) with established osteoporosis. |
|
E.4 | Principal exclusion criteria |
The main exclusion criteria will be: (1) patient experienced hip fracture at last 6 months before M0 visit, (2) patient treated with systemic corticosteroids within the last 6 months before the inclusion and other drugs with influence on the bone metabolism, (3) patient suffering from disease known to influence bone metabolism, (4) patient with previous history of venous trombembolism, (5) history of malignant disease in the prior 5 years, (6) patient suffering from severe renal impairment, (7) patient with phenylketonuria, (8) patient receiving experimental medication other than that recommended in the present study, or having participated to another clinical trial during the previous 3 months, (9) treatment with oral tetracycline or quinolone antibiotics, (10) hypersensitivity to the active substance or to any of the excipients. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary end points are: (1) The compliance with the treatment, (2) The evaluation of treatment persistence, (3) The quality of life assessment. |
|
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Compliance with the treatment |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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.8.5 | 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 | Information not present in EudraCT |
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
|
End of the trial = Last visit of the last patient undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |