E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10027433 |
E.1.2 | Term | Metabolism and nutrition disorders |
|
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 effects of vitamin D 300.000 IU on bone metabolism |
|
E.2.2 | Secondary objectives of the trial |
To assess the effects of vitamin D 300.000 IU on muscolar function, vascular system and infection |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-out patients with type 2 diabetes mellitus, and diabetic foot complications; -age-range: ≥ 60 years; -sex: both men and women; -patients agree to participate and give the written informed consent. |
|
E.4 | Principal exclusion criteria |
-patients with previous or current tumoral disease, with less than 1 year quoad vitam prognosis; -patients with sever chronic or auto-immune inflammatory diseases; -contra-indications of Vit D (chronic renal failure, renal lithiasis, hypercalcemia, hypercalciuria, allergy to calciferole or excipients); -impossibility to perform follow up envisioned in the protocol of the study; -patients treated with strontium ranelate; -treatments effective on bone turnover , including: -bisphosphonates by I.V. or by I.M. and rhPTH by S.C. within the previous 12 months -bisphosphonates, os, for more than 14 days in the previous 12 months -calcitonin, estrogens, ipriflavon, SERMs during the last 6 months -thyroid hormone, except for in case of stable dose for the last 6 months, together with a state of euthyroidism as documented by TSH test -systemic corticosteroids for more than 3 months, at doses greater than the equivalent of 5 mg of prednisone per day, in the previous 12 months; -patients treated with antithrombotic therapies; -gastrointestinal disorders which impair drug absorption; -participation to other clinical trials in the previous 12 months; -poor compliance. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The main endpoint is to determine if there is an improvement in bone metabolism by means the comparison of change between baseline and after 13 and 26 weeks in beta-CTX. |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.3 |
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 | 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
| |
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 | |
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 |