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Trial record 4 of 62 for:    Paraneoplastic Syndromes

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01660308
First received: August 5, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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 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
Hypophosphatemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observing the Changes of Fibroblast Growth Factor 23 in Patients of Tumor Induced Osteomalacia

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • FGF23, P [ Time Frame: at the time TIO is diagnosed ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tumor induced osteomalcia

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with tumor induced osteomalacia and people without osteomalacia

Criteria

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.
  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: NCT01660308

Contacts
Contact: Shyang-Rong Shih, PhD srshih@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shyang-Rong Shih, PhD    886-972653337    srshih@ntu.edu.tw   
Principal Investigator: Shyang-Rong Shih, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shyang-Rong Shih, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01660308     History of Changes
Other Study ID Numbers: 201105045RC
Study First Received: August 5, 2012
Last Updated: September 9, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypophosphatemia
Neoplasms, Connective Tissue
Osteomalacia
Avitaminosis
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Connective Tissue Diseases
Deficiency Diseases
Malnutrition
Metabolic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Nutrition Disorders
Phosphorus Metabolism Disorders
Rickets
Vitamin D Deficiency
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014