E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporosis (DXA-T-Score <-2,0 at lumbar spine, total hip or femur neck OR previous low trauma vertebral fractures) at high fracture risk |
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E.1.1.1 | Medical condition in easily understood language |
Osteoporosis with a high risk of fractures |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 |
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval? |
Ist die Inzidenz osteoporotischer Frakturen bei Osteoporose-Hochrisikopatienten nach mindestens vierjähriger Therapie mit einem Bisphosphonat bei einer weiteren Behandlung mit Alendronat geringer als bei einer Therapiepause? |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Postmenopausal women or men > 60 years, DXA T-Score at lumbar spine, total hip or femur neck <-2,0 OR at least one low traumatic vertebral fracture grade 2/3 or multiple low traumatic vertebral fractures regardless of bone density Pretreatment with bisphosphonates for at least four years Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009 Signed informed consent
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Postmenopausale Frauen oder Männer > 60 Jahre, DXA T-Score an Lendenwirbelsäule, Femurhals oder Gesamthüfte <-2,0 vor Beginn der Bisphosphonattherapie oder bei Studienbeginn oder mindestens eine niedrigtraumatische Wirbelkörperfraktur 2. / 3. Grades oder multiple niedrigtraumatische Wirbelkörperfrakturen unabhängig von der Knochendichte, Bisphosphonat-Vorbehandlung über mind. vier Jahre, Risiko für Hüft- und vertebrale Frakturen mindestens 30 % nach DVO-Leitlinie Osteoporose 2009, Vorliegen einer schriftlichen Einwilligungserklärung
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E.4 | Principal exclusion criteria |
Other pharmacological treatment of osteoporosis during the last 48 months Other bone diseases Malabsorption syndromes Renal insufficiency with a calculated creatinine clearance < 35 ml/min Diseases of the esophagus, delayed esophageal clearance Unrealisability of the intake instructions Hypocalcemia
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Andere medikamentöse Osteoporose-Therapie in den letzten 48 Monaten Andere Knochenerkrankungen Malignome mit bekannter Knochenmetastasierung Malabsorptionssyndrome Niereninsuffizienz mit einer Kreatinin-Clearance < 35 ml/min Erkrankungen des Ösophagus, Verzögerung der ösophagealen Entleerung Nichtrealisierbarkeit der Einnahmemodalitäten Hypokalzämie (< 2,2 mol/L)
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E.5 End points |
E.5.1 | Primary end point(s) |
Osteoporotic fractures |
Osteoporotische Frakturen |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Adverse events, death |
Unerwünschte Ereignisse, Tod |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 70 |
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 | No |
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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Last questionnaire of the last patient |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |