Interactions between the adrenal- and the parathyroid glands

Phase 1

Conditions: Secondary hyperparathyrodism due to Vitamin D deficiency
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2014-003645-10-DK

Lead Sponsor: Department of Endocrinology and Internal Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Age 60-80 postmenopausal women Secondary hyperparathyrodism
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether RAAS blockade will reduce the biochemical changes more than vitamin D supplement alone in patients with secondary hyperparathyrodism.;Secondary Objective: 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;Primary end point(s): p-PTH changes due to RAAS blockade in patients with secondary hyperparathyrodism;Timepoint(s) of evaluation of this end point: End of study, in the beginning of 2017

Secondary Outcome Measures

Name	Time	Method
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;Timepoint(s) of evaluation of this end point: In the beginning of 2017