Cardiovascular Disease, Osteoporosis, Vitamin D Deficiency
Conditions
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.
Interventions
DRUGValsartan
2 weeks of Valsartan 80 mg per day
DRUGPlacebo 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_SUPPLEMENTCholecalciferol
12 weeks of daily cholecalciferol treatment, 70 microgram per day
DIETARY_SUPPLEMENTPlacebo cholecalciferol
12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aldosterone, before and after 12 weeks of daily cholecalciferol treatment | Change from baseline p-aldosterone at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial stiffness | Change from baseline arterial stiffness at 12 weeks | Spygmocor |
| 24 hours arterial stiffness as measured by tonometry | Change from baseline arterial stiffness PWV at 12 weeks | Arteriograph 24 |
| 24 hours blood pressure measured by tonometry | Change from baseline systolic pressure at 12 weeks | Arteriograph 24 |
| Balance as measured by stadiometer (Meitur Ltd) | Change from postural balance at 12 weeks | Postural stability |
| Muscle strength as measured by isometric tests | 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), |
| Bone density and geometry as measured by QCT scans | Change from baseline at 12 weeks | Bone quality in spine and hip as assessed by high resolution quantitative computed tomography HRQCT-scans |
| Bone density and geometry as measured by HRpQCT scans | Change from baseline at 12 weeks | Bone quality in ankle and forearm as assessed by high resolution peripheral quantitative computed tomography HRpQCT-scans |
| Parathyroid hormone, before and after, daily ARB administrations | Change from baseline p-PTH at 2 weeks | — |
| Electrocardiogram | Change from baseline at 2, 6 and 12 weeks | Hearth rhythm, shortened QT interval, hypertrophy |
| Biomarkers of calcium- and bone metabolism | 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. |
| Quality of Life, SF36 | Change from baseline at 12 weeks | SF36v2 |
| Quality of Life, WHO-5 | Change from baseline at 12 weeks | WHO-5 well being index |
| Physical activity | Change from baseline at 12 weeks | Physical activity scale |
| Hyperparathyroid symptoms | Change from baseline at 12 weeks | Pasieka's parathyroid symptoms score |
| Bone density by DXA | Change from baseline at 12 weeks | Bone density assessed by dual energy x-ray absorptiometry (DXA) |
Countries
Denmark
Outcome results
None listed