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Physiologic Interactions Between the Adrenal- and the Parathyroid Glands (AldOst)

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ClinicalTrials.gov Identifier: NCT02572960
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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

Condition or disease Intervention/treatment Phase
Osteoporosis Vitamin D Deficiency Cardiovascular Disease Drug: Valsartan Drug: Placebo Valsartan Dietary Supplement: Cholecalciferol Dietary Supplement: Placebo cholecalciferol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
Actual Study Start Date : October 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Cholecalciferol
Cholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks
Dietary Supplement: Cholecalciferol
12 weeks of daily cholecalciferol treatment, 70 microgram per day
Other Name: Vitamin D3

Active Comparator: Valsartan
Placebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks
Drug: Valsartan
2 weeks of Valsartan 80 mg per day

Placebo Comparator: Placebo
Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks
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: Placebo cholecalciferol
12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
Other Name: Placebo D3

Active Comparator: Cholecalciferol and Valsartan
Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks
Drug: Valsartan
2 weeks of Valsartan 80 mg per day

Dietary Supplement: Cholecalciferol
12 weeks of daily cholecalciferol treatment, 70 microgram per day
Other Name: Vitamin D3




Primary Outcome Measures :
  1. Aldosterone, before and after 12 weeks of daily cholecalciferol treatment [ Time Frame: Change from baseline p-aldosterone at 12 weeks ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572960


Locations
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Denmark
Department of Endocrinology and Internal Medicine
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Lars Rejnmark, Professor Department of Endocrinology and Internal medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02572960     History of Changes
Other Study ID Numbers: 2014-LSB
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoporosis
Vitamin D Deficiency
Cardiovascular Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Valsartan
Parathyroid Hormone
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents