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Completed

NCT Number: NCT02572960

Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

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

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Key information

Conditions

Osteoporosis Avitaminosis Bone Diseases Bone Diseases, Metabolic Cardiovascular Disease Cardiovascular Diseases Deficiency Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Endocrinology and Internal Medicine

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valsartan

Drug

2 weeks of Valsartan 80 mg per day

Placebo Valsartan

Drug

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

Cholecalciferol

Dietary Supplement

12 weeks of daily cholecalciferol treatment, 70 microgram per day

Other names: Vitamin D3

Placebo cholecalciferol

Dietary Supplement

12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

Other names: Placebo D3

Primary outcomes

  1. Aldosterone, before and after 12 weeks of daily cholecalciferol treatment

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

Secondary outcomes

  1. Parathyroid hormone, before and after, daily ARB administrations

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

  2. Arterial stiffness

    Time frame: Change from baseline arterial stiffness at 12 weeks

    Spygmocor

  3. 24 hours arterial stiffness as measured by tonometry

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

    Arteriograph 24

  4. 24 hours blood pressure measured by tonometry

    Time frame: Change from baseline systolic pressure at 12 weeks

    Arteriograph 24

  5. Balance as measured by stadiometer (Meitur Ltd)

    Time frame: Change from postural balance at 12 weeks

    Postural stability

  6. Muscle strength as measured by isometric tests

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

    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),

  7. Bone density and geometry as measured by QCT scans

    Time frame: Change from baseline at 12 weeks

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

  8. Bone density and geometry as measured by HRpQCT scans

    Time frame: Change from baseline at 12 weeks

    Bone quality in ankle and forearm as assessed by high resolution peripheral quantitative computed tomography HRpQCT-scans

  9. Bone density by DXA

    Time frame: Change from baseline at 12 weeks

    Bone density assessed by dual energy x-ray absorptiometry (DXA)

  10. Electrocardiogram

    Time frame: Change from baseline at 2, 6 and 12 weeks

    Hearth rhythm, shortened QT interval, hypertrophy

  11. Biomarkers of calcium- and bone metabolism

    Time frame: Change from baseline at 2, 6 and 12 weeks

    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.

  12. Quality of Life, SF36

    Time frame: Change from baseline at 12 weeks

    SF36v2

  13. Quality of Life, WHO-5

    Time frame: Change from baseline at 12 weeks

    WHO-5 well being index

  14. Physical activity

    Time frame: Change from baseline at 12 weeks

    Physical activity scale

  15. Hyperparathyroid symptoms

    Time frame: Change from baseline at 12 weeks

    Pasieka's parathyroid symptoms score

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: AldOst

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2015
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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