Status:
COMPLETED
Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism
Lead Sponsor:
Campus Bio-Medico University
Conditions:
Chronic Hypoparathyroidism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. According to the European guideline (2015), standard treatment includ...
Detailed Description
BACKGROUND Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. It can be primary (inadequate PTH activity), or secondary ...
Eligibility Criteria
Inclusion
- Diagnosis of postsurgical chronic hypoparathyroidism by at least 6 months
- No change of treatment over the last 3 months prior to enrollment.
- Values of serum calcium and phosphorus stable over the last three months prior to enrollment
- Absence of symptoms from hypocalcaemia in the 3 months prior to enrollment
- A requirement for active vitamin D (calcitriol ≥0.25 mcg daily) and oral calcium (≥1000 mg daily) treatment.
Exclusion
- liver failure
- renal failure (gfr \<30 ml/min)
- hypercalcemia
- hyperthyroidism
- parathyroid disorders
- use of the following drugs within 3 months of the study: diuretics, bisphosphonates, calcitonin, corticosteroids, anabolic steroids, anticonvulsants, H2 receptor antagonists or proton pump inhibitor
- heavy smokers (\>10 cigarettes/day)
- abusing alcohol (\>70 ml/day)
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03425747
Start Date
October 15 2019
End Date
April 1 2020
Last Update
April 3 2020
Active Locations (1)
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1
Campus Bio-Medico University
Roma, Italy, 00128