NCT02572960

Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Osteoporosis
• Vitamin D Deficiency
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Valsartan	2 weeks of Valsartan 80 mg per day
DRUG	Placebo Valsartan	2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
DIETARY_SUPPLEMENT	Cholecalciferol	12 weeks of daily cholecalciferol treatment, 70 microgram per day
DIETARY_SUPPLEMENT	Placebo cholecalciferol	12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-10-09
• Last updated: 2018-08-15

Locations

1 site across 1 country: Denmark