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Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial (ActiVitD)
EU CTIS ID: 2023-510312-40-00
What this study is testing
To investigate the effect of alfacalcidol on the treatment of secondary hyperparathyroidism in patients after RYGB
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and both pre- and postmenopausal women who have had Roux-en-Y-gastric bypass surgery, aged 18 years or above, and present with secondary hyperparathyroidism after surgery, with a vitamin D sufficient state (>50 nmol/l), and only on standard supplementation, are included
- Provide informed consent prior to any specific study procedure
You likely can't join if
- 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)
See the full eligibility criteria
- Men and both pre- and postmenopausal women who have had Roux-en-Y-gastric bypass surgery, aged 18 years or above, and present with secondary hyperparathyroidism after surgery, with a vitamin D sufficient state (>50 nmol/l), and only on standard supplementation, are included
- Provide informed consent prior to any specific study procedure
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.