FGF-23 Suppressibility by Calcitonin
Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.
In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.
placebo-controlled, cross-over study
- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
- On both occasions frequent bloodsampling will take place, out an indwelling catheter in de forearm vein.
- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
- Mealtimes: Calcium and Phosphate intake standardized on both occasions
- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics, San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23
- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca, albumin, PO4, PTH, 25-OHD and 1,25-OHD
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study|
- A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU. [ Time Frame: eight hours ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
Placebo Comparator: 2
NaCl 0,9% 2 ml, single subcutaneous injection
NaCl 0,9 % 1ml, single subcutaneous injection, placebo group
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688077
|Arnhem, Gelderland, Netherlands|