Clinical trial NCT02572960: Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
Official title: Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Vitamin D Deficiency
Cardiovascular Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 81
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aldosterone, before and after 12 weeks of daily cholecalciferol treatment
timeFrame: Change from baseline p-aldosterone at 12 weeks
Secondary outcomes:
measure: Parathyroid hormone, before and after, daily ARB administrations
timeFrame: Change from baseline p-PTH at 2 weeks
measure: Arterial stiffness
timeFrame: Change from baseline arterial stiffness at 12 weeks
measure: 24 hours arterial stiffness as measured by tonometry
timeFrame: Change from baseline arterial stiffness PWV at 12 weeks
measure: 24 hours blood pressure measured by tonometry
timeFrame: Change from baseline systolic pressure at 12 weeks
measure: Balance as measured by stadiometer (Meitur Ltd)
timeFrame: Change from postural balance at 12 weeks
measure: Muscle strength as measured by isometric tests
timeFrame: Change from baseline isometric muscle strength at 12 weeks
measure: Bone density and geometry as measured by QCT scans
timeFrame: Change from baseline at 12 weeks
measure: Bone density and geometry as measured by HRpQCT scans
timeFrame: Change from baseline at 12 weeks
measure: Bone density by DXA
timeFrame: Change from baseline at 12 weeks
measure: Electrocardiogram
timeFrame: Change from baseline at 2, 6 and 12 weeks
measure: Biomarkers of calcium- and bone metabolism
timeFrame: Change from baseline at 2, 6 and 12 weeks
measure: Quality of Life, SF36
timeFrame: Change from baseline at 12 weeks
measure: Quality of Life, WHO-5
timeFrame: Change from baseline at 12 weeks
measure: Physical activity
timeFrame: Change from baseline at 12 weeks
measure: Hyperparathyroid symptoms
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Endocrinology and Internal Medicine
Study officials:
affiliation: Department of Endocrinology and Internal medicine
name: Lars Rejnmark, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
citation: Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Bone Microstructure in Response to Vitamin D3 Supplementation: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2019 Feb;104(2):160-170. doi: 10.1007/s00223-018-0481-6. Epub 2018 Oct 6.
citation: Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Effects of Vitamin D3 Supplementation on Muscle Strength, Mass, and Physical Performance in Women with Vitamin D Insufficiency: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2018 Nov;103(5):483-493. doi: 10.1007/s00223-018-0443-z. Epub 2018 Jun 21.