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Observing the Changes of Fibroblast Growth Factor 23 in Patients of Tumor Induced Osteomalacia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01660308
Recruitment Status : Unknown
Verified July 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 8, 2012
Last Update Posted : July 6, 2016
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Fibroblast froth factors (FGFs) are humoral factors identified by their ability to stimulate cell proliferation1. They play different roles in the regulation of cell proliferation, differentiation and function. Most FGF family members act as paracrine factors. But FGF19(FGF19) subfamily members, including FGF19, 21, and 23, work as endocrine factors to regulate bile acid, carbohydrate and phosphate metabolism2. Of these, FGF23 plays an important role in phosphate and bone metabolism3. FGF23 gene encodes 251 amino acids, including a 24-amino acid signal peptide4. The secreted FGF23 is a protein consisted of 227 amino acids. It works by binding to a Klotho-FGF receptor 1c (FGF1c) complex5. FGF suppresses the expression of type 2a and 2c sodium-phosphate cotransporters, which mediate phosphate reabsorption in proximal tubules.6 FGF23 decreases 25-hydroxyvitamin D-1α-hydroxylase expression and enhances 25-hydroxyvitamin D-24-hydroxylase expression6. Therefore, FGF23 reduces serum 1,25-dihydroxyvitamin D〔1,25(OH)2D〕, which stimulates intestinal calcium and phosphate absorption. FGF23 decreases serum phosphate through the above mechanisms FGF23 over-expression might result in hypophosphatemic rickets and osteomalacia.

Tumor induced osteomalacia (TIO) is a paraneoplastic syndrome usually caused by benign phosphaturic mesenchymal tumors. Symptoms are nonspecific, such as general weakness, fatigue, and bone pain. Sometimes fracture may occurs. The responsible tumors are sometimes small and difficult to detect. Tumors secrete FGF23. FGF23 reduced phosphate reabsorption in the proximal tubules and decrease 1,25(OH)2D levels, which result in hypophosphatemia and then osteomalacia.

The investigators would like to observe the changes of FGF23 in patients who receive operation or medical treatment and hope this will benefit future treatment.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observing the Changes of Fibroblast Growth Factor 23 in Patients of Tumor Induced Osteomalacia
Study Start Date : June 2011
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Tumor induced osteomalcia

Primary Outcome Measures :
  1. FGF23, P [ Time Frame: at the time TIO is diagnosed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with tumor induced osteomalacia and people without osteomalacia

Inclusion Criteria:

  • patients with tumor induced osteomalacia.
  • people without osteomalacia such as healthy people,
  • people under dialysis,
  • people with poor nutrition.

Exclusion Criteria:

  • people younger than 20 years old or older than 85 years old.
  • people who are pregnant.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01660308

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Contact: Shyang-Rong Shih, PhD

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National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shyang-Rong Shih, PhD    886-972653337   
Principal Investigator: Shyang-Rong Shih, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Shyang-Rong Shih, PhD National Taiwan University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital Identifier: NCT01660308    
Other Study ID Numbers: 201105045RC
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Phosphorus Metabolism Disorders
Metabolic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders