Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

Osteoporosis Clinical Trial

— AldOst  

Official title:

Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572960
• Other study ID #: 2014-LSB
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Osteoporosis
• Vitamin D Deficiency

Intervention

Drug:
• Valsartan
2 weeks of Valsartan 80 mg per day
• 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
• Placebo cholecalciferol
12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology and Internal Medicine	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aldosterone, before and after 12 weeks of daily cholecalciferol treatment		Change from baseline p-aldosterone at 12 weeks
Secondary	Parathyroid hormone, before and after, daily ARB administrations		Change from baseline p-PTH at 2 weeks
Secondary	Arterial stiffness	Spygmocor	Change from baseline arterial stiffness at 12 weeks
Secondary	24 hours arterial stiffness as measured by tonometry	Arteriograph 24	Change from baseline arterial stiffness PWV at 12 weeks
Secondary	24 hours blood pressure measured by tonometry	Arteriograph 24	Change from baseline systolic pressure at 12 weeks
Secondary	Balance as measured by stadiometer (Meitur Ltd)	Postural stability	Change from postural balance at 12 weeks
Secondary	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),	Change from baseline isometric muscle strength at 12 weeks
Secondary	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	Change from baseline at 12 weeks
Secondary	Bone density and geometry as measured by HRpQCT scans	Bone quality in ankle and forearm as assessed by high resolution peripheral quantitative computed tomography HRpQCT-scans	Change from baseline at 12 weeks
Secondary	Bone density by DXA	Bone density assessed by dual energy x-ray absorptiometry (DXA)	Change from baseline at 12 weeks
Secondary	Electrocardiogram	Hearth rhythm, shortened QT interval, hypertrophy	Change from baseline at 2, 6 and 12 weeks
Secondary	Biomarkers of calcium- and bone metabolism	Effects of intervention on biochemical markers of calcium and bone metabolism, such as calcium, phosphate, parathyroid hormone, calcitriol, vitamin D-binding protein, bone-specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen (P1NP). Also C-terminal telopeptide of type 1 collagen (CTX) and N-telopeptide of type 1 collagen (NTX) among others.	Change from baseline at 2, 6 and 12 weeks
Secondary	Quality of Life, SF36	SF36v2	Change from baseline at 12 weeks
Secondary	Quality of Life, WHO-5	WHO-5 well being index	Change from baseline at 12 weeks
Secondary	Physical activity	Physical activity scale	Change from baseline at 12 weeks
Secondary	Hyperparathyroid symptoms	Pasieka's parathyroid symptoms score	Change from baseline at 12 weeks