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

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Osteoporosis; Vitamin D Deficiency; Cardiovascular Disease

Treatments: Drug: Valsartan; Dietary Supplement: Cholecalciferol; Drug: Placebo Valsartan; Dietary Supplement: Placebo cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT02572960

2014-LSB

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: Female

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 4 patient groups, including a placebo group

Cholecalciferol

Placebo Comparator group

Description:

Cholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks

Treatment:

Dietary Supplement: Cholecalciferol

Valsartan

Active Comparator group

Description:

Placebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks

Treatment:

Drug: Valsartan

Placebo

Placebo Comparator group

Description:

Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks

Treatment:

Dietary Supplement: Placebo cholecalciferol

Drug: Placebo Valsartan

Cholecalciferol and Valsartan

Active Comparator group

Description:

Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks

Treatment:

Dietary Supplement: Cholecalciferol

Drug: Valsartan