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Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial (ActiVitD)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510312-40-00
Enrollment
130
Registered
2024-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary hyperparathyroidism

Brief summary

Normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 2 years after diagnosis and start of treatment in one of the study groups. Secondary hyperparathyroidism will be defined as PTH at the upper limit or above the labs reference value combined with a normal or decreased serum calcium level (in patients with 25(OH)D >50 nmol/L

Detailed description

Decrease in BMD (defined as 3% decrease in T-score at the lumbar spine and 5% decrease in T-score at the hip / forearm), measured at 1 and 2 years after inclusion, Quality of life is measured after inclusion and thereafter every 6 months with the OBESI-Q questionnaire

Interventions

DRUGEtalpha 0
DRUG5 microgram zachte capsules
DRUG25 microgram zachte capsules
DRUGEtalpha 1 microgram zachte capsules

Sponsors

Academisch Ziekenhuis Leiden
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 2 years after diagnosis and start of treatment in one of the study groups. Secondary hyperparathyroidism will be defined as PTH at the upper limit or above the labs reference value combined with a normal or decreased serum calcium level (in patients with 25(OH)D >50 nmol/L

Secondary

MeasureTime frame
Decrease in BMD (defined as 3% decrease in T-score at the lumbar spine and 5% decrease in T-score at the hip / forearm), measured at 1 and 2 years after inclusion, Quality of life is measured after inclusion and thereafter every 6 months with the OBESI-Q questionnaire

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026