E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal women with vitamin D deficiency. |
Donne in menopausa con carenza di vitamina D. |
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E.1.1.1 | Medical condition in easily understood language |
Postmenopausal women with vitamin D deficiency. |
Donne in menopausa con carenza di vitamina D. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047626 |
E.1.2 | Term | Vitamin D deficiency |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 assess the percentage of patients achieving 25(OH)D levels above 30 ng/mL at 4 months of treatment in each of the treatment groups investigated. |
Valutare la percentuale di pazienti che hanno raggiunto livelli di 25(OH)D superiori ai 30 ng/mL dopo 4 mesi di trattamento, in ciascuno dei gruppi di trattamento sotto studio. |
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E.2.2 | Secondary objectives of the trial |
-To assess the percentage of patients achieving 25(OH)D levels above 30 ng/mL at 1, 8, and 12 months of treatment in each of the treatment groups investigated. -Time to achieve the treatment goal (> 30 ng/mL) in each of the treatment investigated. -Mean change in 25(OH)D levels at 1, 4, 8, and 12 months in each of the treatments investigated. -Change in levels of bone resorption markers CTX and P1NP in the stratum of non-osteoporotic patients at baseline, 4, 8, and 12 months in each of the treatments investigated. -Change in levels of total serum calcium (tCa), PTH, albumin, phosphorus and total alkaline phosphatase at screening, 1, 4, 8 and 12 months in each of the treatments investigated. -Modulation of 25(OH)D levels according to phenotype taking into account the age and obesity (BMI and abdominal circumference). .... |
-Valutare la percentuale di pazienti che hanno raggiunto livelli di 25(OH)D superiori ai 30 ng/mL, dopo 1, 8, 12 mesi di trattamento, in ciascuno dei gruppi di trattamento sotto studio. - Tempo per raggiungere l¿obiettivo di trattamento (> 30 mg/mL) per ciascun trattamento sotto studio -Cambiamento medio dei livelli di 25(OH)D dopo 1, 4, 8, 12 mesi per ciascun trattamento sotto studio. -Cambiamento nei livelli dei marcatori di riassorbimento osseo CTX e P1NP, nello strato delle pazienti non osteoporotiche al basale e dopo 4, 8, 12 mesi in ciascun trattamento sotto studio. -Cambiamento nei livelli di calcio totale sierico (tCa), PTH, albumina, fosfatasi totale alcalina e fosforosa al momento dello screening e dopo 1, 4, 8, 12 mesi in ciascun trattamento sotto studio. -Modulazione dei livelli di 25(OH)D, in base al fenotipo, tenendo in considerazione l¿et¿ e l¿obesit¿ (BMI e circonferenza addominale). .... |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetics Version: \ Date: 19/12/2017 Title: Genetic study. Objectives: On baseline visit, patients who have consented to perform a genetic study, a whole blood sample will be obtained and frozen to -80¿C to determine polymorphisms related to vitamin D levels (1a -hydroxylase enzyme, Vitamin D catabolism, Vitamin D receptor and transporting protein).
Other types of substudies Specify title, date and version of each substudy with relative objectives: Consent is required for the donation of samples to Biobanco Vasco, of the Fundaci¿n Vasca de Innovaci¿n and Investigaci¿n Sanitaria (BIOEF), so that it can be stored and destined for future biomedical experiments.
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Farmacogenetica Versione: \ Data: 19/12/2017 Titolo: Studio genetico. Obiettivi: Alla visita basale, dalle pazienti che abbiano acconsentito a partecipare allo studio genetico verra` prelevato un campione di sangue intero, da congelare a -80¿C, per determinare successivamente i polimorfismi correlati ai livelli di vitamina D (enzima 1a-idrossilasi, catabolismo della vitamina D, recettore della vitamina D, proteina trasportatrice).
Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Si richiede il consenso per la donazione di campioni a Biobanco Vasco, della Fundaci¿n Vasca de Innovaci¿n e Investigaci¿n Sanitaria (BIOEF), affinch¿ possa essere conservato e destinato a future sperimentazioni biomediche.
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E.3 | Principal inclusion criteria |
-Postmenopausal women: amenorrhea for more than 6 months or FSH above 30 IU/l with estradiol under 30 pg/mL. -Women with vitamin D deficiency (25-hydroxycholecalciferol levels < 20 ng/mL). -Postmenopausal patients who are NON-OSTEOPOROTIC and are NOT receiving treatment with drugs affecting bone metabolism OR postmenopausal patients who are OSTEOPOROTIC and receiving treatment WITH antiresorptives, biphosphonates or denosumab. -Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions. |
- Donne in post-menopausa: amenorrea da oltre 6 mesi o FSH superiore a 30 IU/l con estradiolo al di sotto di 30 pg/mL. - Donne con carenza di vitamina D (livelli di 25-idrossicalciferolo < 20 ng/mL). - Pazienti in post-menopausa NON OSTEOPOROTICHE e NON sottoposte a trattamenti con farmaci che abbiano ripercussioni sul metabolismo osseo OPPURE pazienti in post-menopausa che siano OSTEOPOROTICHE e sottoposte a trattamento CON antiriassorbitivi, bifosfonati o denosumab. - Sottoscrizione del documento sul consenso informato, a conferma della comprensione delle finalità e delle procedure previste dallo studio e della volontà di partecipare allo studio e di attenersi a tutte le procedure e alle limitazioni da esso previste. |
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E.4 | Principal exclusion criteria |
-Patients taking drugs that modify vitamin D levels: phenobarbital, phenytoin, rifampicin, antiretrovirals (tenofivir, adenofivir), long-term corticosteroids, orlistat and cholestiramine. -Patients taking any nutritional supplement such as vitamin complexes. -Patients diagnosed with malabsorption -Patients with kidney stones -Patients with primary hyperparathyroidism -Patients with hyperthyroidism -Patients with hypercalcemia -Patients with creatinine clearance < 30 mL/min -Patients with tumours within the last 5 years -Patients who have a history with evidence of diseases, medications, laboratory abnormalities or any other circumstance that could alter the conduct of the study -Patients who are allergic to any of the ingredients of the medication etanol, medium-chain triglycerides, gelatine, vegetal glicerine, sorbitol (E-420), titanium dioxide (E-171),orangish yellow colorant and purified water. refined olive oil) -Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the screening or is currently enrolled in an investigational interventional study. |
- Pazienti che assumano farmaci modificanti i livelli di vitamina D: fenobarbiturici, fenitoina, rifampicina, antiretrovirali (tenofivir, adenofivir), corticosteroidi a lungo termine, orlistat e colestiramina. - Pazienti che assumono qualsiasi integratore alimentare, ad es. complessi vitaminici. - Pazienti a cui siano diagnosticati problemi di malassorbimento - Pazienti affette da calcolosi - Pazienti affette da iperparatiroidismo primitivo - Pazienti affette da ipertiroidismo - Pazienti affette da ipercalcemia - Pazienti affette da clearance della creatinina < 30 mL/min - Pazienti affette da tumori entro gli ultimi 5 anni - Pazienti la cui anamnesi presenti evidenze di malattie, terapie farmacologiche, anomalie da laboratorio o qualsiasi altra circostanza che possa alterare la condotta dello studio - Pazienti allergiche a qualsiasi componente presente nel farmaco, tra cui etanolo, trigliceridi a catena media, gelatina, glicerina vegetale, sorbitolo (E-420), biossido di titanio (E-171), colorante giallo aranciastro e acqua purificata. olio d’oliva raffinato. - Pazienti a cui siano stati somministrati farmaci sperimentali (tra cui vaccini sperimentali) o che abbiano fatto uso di dispositivi medici sperimentali invasivi entro 30 giorni dall’inizio dello screening, o che siano attualmente reclutate in uno studio interventistico sperimentale. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients achieving 25(OH)D levels above 30 ng/mL at 4 months of treatment. |
Percentuale di pazienti che hanno raggiunto livelli di 25(OH)D superiori ai 30 ng/mL dopo 4 mesi di trattamento. |
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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) |
Percentage of patients achieving 25(OH)D levels above 30 ng/mL at 1, 8, and 12 months of treatment.; Mean change from screening of 25(OH)D serum concentrations at 1, 4, 8, and 12 months of treatment.; Time to achieve treatment objective. (25(OH)D > 30 ng/mL) ; Serum concentrations of total serum calcium (tCa), PTH, albumin, phosphorus and total alkaline phosphatase will be assessed at screening and at 1, 4, 8, and 12 months.; Serum concentrations of P1NP and ¿-CTX at baseline, 4, 8, and 12 months in non-osteoporotic patients. |
Percentuale di pazienti che hanno raggiunto livelli di 25(OH)D superiori ai 30 ng/mL dopo 1, 8, 12 mesi di trattamento.; Cambiamento medio dal momento dello screening delle concentrazioni di siero di 25(OH)D dopo 1, 4, 8, 12 mesi di trattamento.; Tempo per raggiungere l¿obiettivo di trattamento (25(OH)D > 30 ng/mL).; Concentrazioni di siero per calcio totale sierico (tCa), PTH, albumina, fosfatasi totale alcalina e fosforosa dopo 1, 4, 8, 12 mesi.; Concentrazioni di siero per P1NP e ¿-CTX al basale e dopo 4, 8, 12 mesi sui pazienti non osteoporotici. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 8, 12 months; 1, 4, 8, and 12 months; \; 1, 4, 8, and 12 months; at baseline, 4, 8, and 12 months |
1, 8, 12 mesi; 1, 4, 8, 12 mesi; \; 1, 4, 8, 12 mesi; al basale e dopo 4, 8, 12 mesi |
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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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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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The end of the study will take place once the last randomized patient that has not abandoned the study prematurely has completed the last follow-up contact (the last visit of the last patient, LP/LV: ¿last patient, last visit¿). |
La fine dello studio avverr¿ quando l'ultimo paziente randomizzato che non ha abbandonato lo studio in modo prematuro ha completato l'ultimo contatto di follow-up (l'ultima visita dell'ultimo paziente, LP / LV: "ultimo paziente, ultima visita"). |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 17 |
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 | 17 |
E.8.9.2 | In all countries concerned by the trial days | 0 |