Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

University of Aarhus81 enrolled

Overview

To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.

In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to inhibit the RAAS. However, a possible physiologic interaction needs further investigation. The purpose of the study is to investigate changes in the RAAS in otherwise healthy postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when p-PTH is normalized. Furthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in patients with secondary hyperparathyroidism.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoporosis Vitamin D Deficiency Cardiovascular Disease

Interventions

ValsartanDRUG

2 weeks of Valsartan 80 mg per day

Placebo ValsartanDRUG

2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

CholecalciferolDIETARY_SUPPLEMENT

12 weeks of daily cholecalciferol treatment, 70 microgram per day

Eligibility

Sex: FEMALEMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Secondary hyperparathyroidism due to Vitamin D deficiency Exclusion Criteria: * Cardiovascular disease * Renal failure * Liver failure * Treatment with antihypertensive medication or diuretics * Treatment with lithium, NSAID or glucocorticoids * Calcium supplement more than 500 mg per day or Vitamin D supplement more than 25 microgram per day * Medical treatment for osteoporosis * Systolic blood pressure below 120 mmHg * Hypercalcaemia (more than 1,33mmol/L) * Use of solarium or planned trip to countries, that might increase the endogenous vitamin D synthesis * Allergic reaction to ACEi or ARBs.

Locations (1)

Department of Endocrinology and Internal Medicine

Aarhus, Denmark

Outcomes

Primary Outcomes

Aldosterone, before and after 12 weeks of daily cholecalciferol treatment

Time frame: Change from baseline p-aldosterone at 12 weeks

Secondary Outcomes

Parathyroid hormone, before and after, daily ARB administrations

Time frame: Change from baseline p-PTH at 2 weeks

Arterial stiffness

Spygmocor

Time frame: Change from baseline arterial stiffness at 12 weeks

24 hours arterial stiffness as measured by tonometry

Arteriograph 24

Time frame: Change from baseline arterial stiffness PWV at 12 weeks

24 hours blood pressure measured by tonometry

Arteriograph 24

Time frame: Change from baseline systolic pressure at 12 weeks

Balance as measured by stadiometer (Meitur Ltd)

Postural stability

Time frame: Change from postural balance at 12 weeks

Muscle strength as measured by isometric tests

Effects on muscle strength (isometric tests of flexion and extension of thigh and hand), two function-tests (timed up-and go and timed stand-and-sit),

Time frame: Change from baseline isometric muscle strength at 12 weeks

Bone density and geometry as measured by QCT scans

Bone quality in spine and hip as assessed by high resolution quantitative computed tomography HRQCT-scans

Time frame: Change from baseline at 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.