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Status unknownNCT01660308Updated Jul 6, 2016

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

An observational study in Hypophosphatemia, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-06.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
20 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Hypophosphatemia

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03

In context

Hypophosphatemia

53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.

This study's planned enrollment of 40 is below the median of 105 across 26 observational studies indexed under Hypophosphatemia.

Browse Hypophosphatemia studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with tumor induced osteomalacia and people without osteomalacia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Tumor induced osteomalcia
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What researchers measure

Primary outcomes

  1. FGF23, P

    Time frame: at the time TIO is diagnosed

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Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
    • Shyang-Rong Shih, PhD · Contactsrshih@ntu.edu.tw · 886-972653337
    • Shyang-Rong Shih, PhD · Principal investigator
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References and documents

Publications

  • Lin CH, Chang CK, Shih CW, Li HY, Chen KY, Yang WS, Tsai KS, Wang CY, Shih SR. Serum fibroblast growth factor 23 and mineral metabolism in patients with euthyroid Graves' diseases: a case-control study. Osteoporos Int. 2019 Nov;30(11):2289-2297. doi: 10.1007/s00198-019-05116-1. Epub 2019 Aug 5. PubMed 31384956 ↗
  • Lin HA, Shih SR, Tseng YT, Chen CH, Chiu WY, Hsu CY, Tsai KS. Ovarian cancer-related hypophosphatemic osteomalacia--a case report. J Clin Endocrinol Metab. 2014 Dec;99(12):4403-7. doi: 10.1210/jc.2014-2120. PubMed 25181387 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2012
First posted
Aug 8, 2012
Start
Jun 2011
Primary completionEst.
Aug 2016
CompletionEst.
Aug 2016
Last update
Jul 6, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01660308
Responsible party
Sponsor
First posted
Aug 8, 2012
Start date
Jun 2011
Primary completion
Aug 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
Jul 6, 2016

Study contacts

Shyang-Rong Shih, PhD
Contact
srshih@ntu.edu.tw
Shyang-Rong Shih, PhD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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