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To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Placebo Comparator | Cholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks |
|
| Valsartan | Active Comparator | Placebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks |
|
| Placebo | Placebo Comparator | Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks |
|
| Cholecalciferol and Valsartan | Active Comparator | Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan | Drug | 2 weeks of Valsartan 80 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aldosterone, before and after 12 weeks of daily cholecalciferol treatment | Change from baseline p-aldosterone at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroid hormone, before and after, daily ARB administrations | Change from baseline p-PTH at 2 weeks | |
| Arterial stiffness | Spygmocor | Change from baseline arterial stiffness at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Rejnmark, Professor | Department of Endocrinology and Internal medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Internal Medicine | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018442 | Derived | 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. | |
| 30293198 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 1, 2020 | |
| Reset | Apr 13, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2020 | Apr 13, 2020 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D014808 | Vitamin D Deficiency |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
|
|
| 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. |
|
|
| 24 hours arterial stiffness as measured by tonometry | Arteriograph 24 | Change from baseline arterial stiffness PWV at 12 weeks |
| 24 hours blood pressure measured by tonometry | Arteriograph 24 | Change from baseline systolic pressure at 12 weeks |
| Balance as measured by stadiometer (Meitur Ltd) | Postural stability | Change from postural balance at 12 weeks |
| 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 |
| 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 |
| 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 |
| Bone density by DXA | Bone density assessed by dual energy x-ray absorptiometry (DXA) | Change from baseline at 12 weeks |
| Electrocardiogram | Hearth rhythm, shortened QT interval, hypertrophy | Change from baseline at 2, 6 and 12 weeks |
| 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 |
| Quality of Life, SF36 | SF36v2 | Change from baseline at 12 weeks |
| Quality of Life, WHO-5 | WHO-5 well being index | Change from baseline at 12 weeks |
| Physical activity | Physical activity scale | Change from baseline at 12 weeks |
| Hyperparathyroid symptoms | Pasieka's parathyroid symptoms score | Change from baseline at 12 weeks |
| 29931459 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |