E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Reduction of periprosthetic bone loss in patients with total hip arthoplasty for coxarthrosis |
Riduzione della perdita ossea periprotesica in pazienti con artroplastica totale dell'anca per coxoartrosi |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052306 |
E.1.2 | Term | Periprosthetic osteolysis |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
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 show the efficacy of strontium ranelate versus placebo in the reduction of periprosthetic bone loss in region 7 of Gruen, over 12 months of treatment after total hip arthroplasty. |
Mostrare l’efficacia del ranelato di stronzio contro placebo nella riduzione della perdita ossea periprotesica nella regione 7 di Gruen, durante 12 mesi di trattamento dopo artroplastica totale dell'anca. |
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E.2.2 | Secondary objectives of the trial |
To show the efficacy of strontium ranelate versus placebo in the reduction of periprosthetic bone loss in proximal and total regions of interest and in region 1 to 6 of Gruen, over 12 months of treatment. To assess the efficacy of strontium ranelate versus placebo on the same criteria described above over 6 months of treatment. To assess the safety of strontium ranelate over 12 months of treatment. |
Mostrare l’efficacia del ranelato di stronzio contro placebo nella riduzione della perdita ossea periprotesica nella regione prossimale e totale di interesse e nelle regioni da 1 a 6 di Gruen durante 12 mesi di trattamento. - Valutare l’efficacia del ranelato di stronzio contro placebo per gli stessi criteri sopra descritti durante 6 mesi di trattamento. - Valutare la sicurezza del ranelato di stronzio durante 12 mesi di trattamento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Caucasian men or postmenopausal women, Age ≥ 50 years, Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication of total hip arthroplasty. |
Uomini e donne in postmenausa. - Razza caucasica. - Eta' ≥ 50 anni. - Pazienti con artroplastica convenzionale totale dell’anca, stelo femorale non cementato, coxartrosi primaria come indicazione della artroplastica totale dell’anca. |
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E.4 | Principal exclusion criteria |
Short femoral stem, -Any perioperative complication, -Patients with inflammatory arthropathy, -Impossibility to perform DXA, -Increased risk or history of VTE, -Known hypersensitivity or contraindication to the study drug or Calperos D3. |
Stelo femorale corto, - Qualsiasi complicazione perioperatoria, - Pazienti con artropatia infiammatoria, -Impossibilta' a svolgere la DXA, -Aumentato rischio o storia di VTE, -Nota ipersensibilita' o controindicazione al trattamento in studio o al Calperos D3. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The relative change of periprosthetic BMD in region 7 of Gruen from baseline to last post baseline value over 12 months of treatment after total hip arthroplasty. |
La variazione relativa della BMD periprotesica nella regione 7 di Gruen dalla baseline all’ultimo valore post-baseline durante 12 mesi di trattamento dalla artroplastica totale dell’anca. |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | No |
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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
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 | 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 | 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 | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | 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
|
Ultima visita dell'ultimo paziente come definito nel protocollo. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |