treatment of elevated parathyroid hormone with active vitamin D (alfacalcidol) after bariatric surgery

Phase 1

• Conditions: patients with secondary hyperparathyroidism after Roux-en-Y gastric bypass surgery (RYGB).; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2022-000178-24-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-28
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-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.

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 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-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 clinical trial of medicinal product
• Study Design: Not specified