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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Leiden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Decision date (initial)

2024-11-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-510312-40-00

EudraCT number

2022-000178-24

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate the effect of alfacalcidol on the treatment of secondary hyperparathyroidism in patients after RYGB

Secondary objectives 2

1. To investigate bone turnover and changes in BMD in relation to alfacalcidol treatment of secondary hyperparathyroidism in patients after RYGB
2. To investigate quality of life, medication adherence and cost benefits related to hyperparathyroidism and medication intake in patients after RYGB

Conditions and MedDRA coding

Secondary hyperparathyroidism

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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
2. Provide informed consent prior to any specific study procedure

Exclusion criteria 7

1. Patients who are already on active treatment for osteoporosis before inclusion
2. Patients with chronic kidney disease defined as eGFR < 60 ml/min
3. Patients who had a bariatric intervention before and are re-operated
4. Patients that are on chronic steroid use, for example for inflammatory conditions
5. Patients that appear to have hypercalcemia on screening
6. Patients with known inflammatory conditions (i.e. rheumatoid arthritis)
7. Patients that have an active pregnancy wish

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 2

1. 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
2. Quality of life is measured after inclusion and thereafter every 6 months with the OBESI-Q questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Leiden

Sponsor organisation

Academisch Ziekenhuis Leiden

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

N.M. Appelman-Dijkstra

Public contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

N.M. Appelman-Dijkstra

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications