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FGF-23 Suppressibility by Calcitonin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rijnstate Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00688077
First received: May 28, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

Introduction:

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.

Aim:

In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

Study Design:

placebo-controlled, cross-over study

Method:

  • 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

Endpoint:

A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.


Condition Intervention
Hypophosphatemia
Drug: Calcitonin
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: May 2008
Arms Assigned Interventions
Experimental: 1 Drug: Calcitonin
Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
Placebo Comparator: 2
NaCl 0,9% 2 ml, single subcutaneous injection
Drug: Placebo
NaCl 0,9 % 1ml, single subcutaneous injection, placebo group

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.

Exclusion Criteria:

  • Serum creatinin >100 mmol/L, or glomerular filtration rate <80 ml/min.
  • Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels.
  • Any medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688077

Contacts
Contact: Hans Boer de, MD, PhD 31-2-6378-8888 hdeboer@alysis.nl
Contact: Carmen Horjus, MD chthorje@alysis.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands
Principal Investigator: Hans Boer de, MD, PhD         
Sponsors and Collaborators
Rijnstate Hospital
  More Information

No publications provided

Responsible Party: H. de Boer MD. PhD., Rijnstate Hospital, Arnhem
ClinicalTrials.gov Identifier: NCT00688077     History of Changes
Other Study ID Numbers: LTC-524/030408
Study First Received: May 28, 2008
Last Updated: August 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
Fibroblast growth factor - 23
Calcitonin

Additional relevant MeSH terms:
Hypophosphatemia
Metabolic Diseases
Phosphorus Metabolism Disorders
Calcitonin
Calcitonin Gene-Related Peptide
Salmon calcitonin
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014