increased parathyroid hormone lever
Conditions
Interventions
Intervention:
- A. Standard care in case hyperparathyroidism the dose of calcichew-D3 is
increased to 1000/800 3dd1
- B: Intervention: calcichew-D3 500/800 3dd1 + stepwise supplementation of
alfac
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria: - Patients who are already on active treatment for osteoporosis before inclusion - Patients with chronic kidney disease defined as eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameters: normalization of PTH (and thus recovery of secondary hyperparathyroidism) at 1 and 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
| Measure | Time frame |
|---|---|
| Secondary outcome parameters: 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. As DEXA BMD measurements at regular sites (hip, spine) depend on body weight and circumference to a certain extent, BMD measurement of the forearm will be performed because this site is known to be less influenced by surrounding tissue. For a reflection on bone turnover, serum bone turnover markers (P1NP, b-crosslaps, alkaline phosphatase) will be measured. Quality of life is measured after inclusion and thereafter every 6 months with the OBESI-Q (https://dica.nl/dato/documenten) questionnaire, a relatively new questionnaire which is validated and endorsed by the Dutch Society of Metabolic and Bariatric Surgery (DSMBS) and the Dutch society for Internal Medicine (Nederlandse Internisten Vereniging; NIV) and the patients society (Stichting OverGewicht). This questionnaire is part of Dutch Audit for Treatment Of Obesity (DATO) which aims to registrate the results of all bariatric procedures performed in the Netherlands. The EQ5D questionnaire will be completed every 6 months to asses generic health status for health economic benefits. Medication adherence will be measured every 6 months with the validated Promise questionnaire, which includes the MARS (Medication Adherence Report Scale) questions which are used by pharmacists to screen for adherence and side effects. | — |
Countries
Netherlands
Outcome results
None listed