E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondary hyperparathyrodism due to Vitamin D deficiency |
Sekundær hyperparathyroidisme pga. D vitamin mangel |
|
E.1.1.1 | Medical condition in easily understood language |
Vitamin D deficiency |
D vitamin mangel |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
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 |
To assess whether RAAS blockade will reduce the biochemical changes more than vitamin D supplement alone in patients with secondary hyperparathyrodism. |
At undersøge om RAAS blokade normaliserer de biokemiske forandringer man ser ved sekundær hyperparathyroidisme mere end D-vitamin tilskud alene |
|
E.2.2 | Secondary objectives of the trial |
If a vitamin D supplement in patients with secondary hyperparathyrodism a) reduces p-aldosterone b) Reduces arterial stiffness and bloodpressure c) Improves bone mineral mineralisation and muscle function d) improves quality of life |
Om normalisering af D-vitamin status hos patienter med SHPT som følge af vitamin D insufficiens: a) Fører til et fald i plasma aldosteron b) Påvirker risikoen for kardiovaskulær sygdom (CVD) bedømt ud fra surrogatparametre bestemt ved tonometri (blodtryk, pulse wave velocity mv.) c) Fører til en bedret knoglemineraltæthed (Bone mineral density (BMD)) og muskelstyrke/funktion. d) Påvirker livskvaliteten. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 60-80 postmenopausal women Secondary hyperparathyrodism |
|
E.4 | Principal exclusion criteria |
Cardiovascular disease Renal failure Liver failure Treatment with diuretics or antihypertensive medicamentation Supplement of calcium (more than 500 mg/day) and Vitamin D (more than 25 mikrogram/day). ) Treatment with lithium or permanent NSAIDS or systemic glucocorticoids. Medical treatment for osteoporosis Systolic bloodpressure below 120 mmHg Hypercalcaemia Travelling to countries with sunexposition during the winter half year Allergic reaction at ACE inhibitors or ARBs. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
p-PTH changes due to RAAS blockade in patients with secondary hyperparathyrodism |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study, in the beginning of 2017 |
|
E.5.2 | Secondary end point(s) |
Cardiovascular surrogate markers (arterial stiffness and 24 hours bloodpressure) Bone scans Balance- and muscular function Blod and urinary test for biochemical markers of calcium homeostasis, adrenal metabolism and cardiovascular risk factors. Quality of life, general informations and phycical activity: questionaries |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 4 |
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.8.5 | 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 | 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
|
The inclusion ends when 80 study subjects are included. The trial ends at the last visis 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 | 0 |