Interactions between the adrenal- and the parathyroid glands

Physiological interactions between the adrenal- and the parathyroid glands described by controlled clinical trials - AldOst

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003645-10-DK

Enrollment

Registered

2014-10-02

Start date

2014-11-27

Completion date

Unknown

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary hyperparathyrodism due to Vitamin D deficiency

Interventions

Trade Name: Valsartan 2care4 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Denmark

Contacts

Public ContactOsteoporoseklinikken

Department of endocrinology and internal medicine

lise.sofie@auh.rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026