FGF-23 Suppressibility by Calcitonin
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|ClinicalTrials.gov Identifier: NCT00688077|
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : June 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypophosphatemia||Drug: Calcitonin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2012|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688077
|Arnhem, Gelderland, Netherlands|