IMPACT OF VITAMIN D SUPPLEMENTATION ON SKELETAL AND NON SKELETAL MANIFESTATIONS IN PATIENTS WITHPRIMARY HYPERPARATHYROIDISM SUBMITTED TO PARATHYROIDECTOMY OR FOLLOWED WITHOUT SURGERY
Phase 1
Active, not recruiting
- Conditions
- PRIMARY HYPERPARATHYROIDISMMedDRA version: 20.0Level: LLTClassification code 10036693Term: Primary hyperparathyroidismSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2013-005027-16-IT
- Lead Sponsor
- CASA SOLLIEVO DELLA SOFFERENZA IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
Postmenopausal female PHPT patients aged 45-80 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
Exclusion Criteria
familial forms of PHPT; serum calcium above 12.5 mg/dL; malignancy other than nonmelanoma skin cancer, diseases or medications known to affect mineral metabolism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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What molecular mechanisms link vitamin D supplementation to parathyroid hormone regulation in primary hyperparathyroidism?
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Which biomarkers are associated with improved outcomes following vitamin D supplementation in primary hyperparathyroidism patients post-parathyroidectomy?
What are the potential adverse events of long-term vitamin D supplementation in primary hyperparathyroidism and how can they be managed?
Are there combination therapies involving vitamin D and calcimimetics that enhance treatment efficacy in primary hyperparathyroidism?