Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial.
- Conditions
- increased parathyroid hormone lever1003394910013296
- Registration Number
- NL-OMON53666
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Men and both pre- and postmenopausal women who have had Roux-en-Y-gastric
bypass surgery and present with secondary hyperparathyroidism after surgery,
with a vitamin D sufficient state (>50 nmol/l), and only on standard
supplementation, are included.
- Patients who are already on active treatment for osteoporosis before inclusion
- Patients with chronic kidney disease defined as eGFR < 60 ml/min
- Patients who had a bariatric intervention before and are re-operated
- Patients that are on chronic steroid use, for example for inflammatory
conditions
- Patients that appear to have hypercalcemia on screening
- Patients with known inflammatory conditions (i.e. rheumatoid arthritis)
- Patients that have an active pregnancy wish
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome parameters: normalization of PTH (and thus recovery of<br /><br>secondary hyperparathyroidism) at 1 and 2 years after diagnosis and start of<br /><br>treatment in one of the study groups. Secondary hyperparathyroidism will be<br /><br>defined as PTH at the upper limit or above the labs reference value combined<br /><br>with a normal or decreased serum calcium level (in patients with 25(OH)D >50<br /><br>nmol/L).</p><br>
- Secondary Outcome Measures
Name Time Method
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