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CompletedNCT04846647IFEHUpdated May 11, 2023

Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia

An observational study in Hypophosphatemia Without Immediate Anteriority and Unexplained Hypophosphatemia, sponsored by University Hospital, Clermont-Ferrand. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
18 Years and older
Sex
All
01

Study summary

The discovery of FGF23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. By inhibiting the renal reabsorption of phosphate and the production of calcitriol, FGF23 behaves like a hypophosphatemia hormone.

Hypersecretion of FGF23 can occur in the case of genetic abnormalities (X-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, McCune-Albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). Oncogenic osteomalacia can be induced by hyperproduction of FGF23 by benign tumours of mesenchymal origin. But more recently, several cases of malignant tumours secreting FGF23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

Read the detailed description

To date, even if the incidence of FGF23-secreting tumours seems rare, no precise bibliographical data is available in the scientific literature. Future studies will have to address this issue in order not to underestimate the frequency of this complication.

In this context, investigators would like to study the incidence of inappropriate FGF23 increase from a collection of biological samples carried out on 500 patients treated at the Clermont-Ferrand University Hospital for hypophosphatemia.

02

Conditions studied

  • Hypophosphatemia Without Immediate Anteriority
  • Unexplained Hypophosphatemia

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Keywords

  • FGF-23
  • Unexplained hypophosphatemia
  • Phosphate metabolism
  • Physiopathology of hypophosphatemia
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In context

Hypophosphatemia

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

This study's enrollment of 260 is above the median of 105 across 26 observational studies indexed under Hypophosphatemia.

Browse Hypophosphatemia studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Major patient, male or female with hypophosphatemia (\< 0.80 mmol/L), without immediate anteriority

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

  • Major patient, male or female
  • Taken care of at the Clermont-Ferrand University Hospital or the Jean Perrin Centre
  • In a context of hypophosphatemia (\< 0.80 mmol/L), without immediate anteriority and not occurring during hospitalisation
  • In capacity to express to participate in research
  • Affiliated to a social security system

Exclusion criteria

Exclusion Criteria:

  • Previously diagnosed hypophosphatemia
  • Hypophosphatemia during hospitalisation
  • Haemodialysis patient
  • Refusal to participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (actual)
Patient registry
No

Groups and cohorts

  • Unexplained hypophosphatemia

    Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care.

    Behavioral: unexplained hypophoshatemia

Interventions

  • Behavioralunexplained hypophoshatemia

    Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care.

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What researchers measure

Primary outcomes

  1. Evaluate the frequency of blood levels of FGF23 unsuitable for hypophosphatemia

    Assessing the presence of a blood level of FGF23 considered unsuitable for hypophosphatemia

    Time frame: day 0

Secondary outcomes

  1. Investigate the relationship between blood levels of FGF23 and other biochemical parameters in hospital patients with hypophosphatemia..

    Description: Measure blood levels of FGF23 in absolute value and other biochemical parameters (phosphatemia, phosphaturia, PTH, vitamin D ...)

    Time frame: Day 1

  2. Investigate the relationship between blood levels of FGF23 and other biochemical parameters in hospital patients with hypophosphatemia.

    Measure blood levels of FGF23 in absolute value and other biochemical parameters (phosphatemia, phosphaturia, PTH, vitamin D ...).

    Time frame: day 1

07

Study locations

2 sites
  • Chu Clermont Ferrand
    Clermont-Ferrand, 63003, France
  • Centre Jean Perrin
    Clermont-Ferrand, France
08

References and documents

Publications

  • Suvannasankha A, Tompkins DR, Edwards DF, Petyaykina KV, Crean CD, Fournier PG, Parker JM, Sandusky GE, Ichikawa S, Imel EA, Chirgwin JM. FGF23 is elevated in multiple myeloma and increases heparanase expression by tumor cells. Oncotarget. 2015 Aug 14;6(23):19647-60. doi: 10.18632/oncotarget.3794. PubMed 25944690 ↗
  • Imel EA, Biggin A, Schindeler A, Munns CF. FGF23, Hypophosphatemia, and Emerging Treatments. JBMR Plus. 2019 May 13;3(8):e10190. doi: 10.1002/jbm4.10190. eCollection 2019 Aug. PubMed 31485552 ↗
  • Endo I, Fukumoto S, Ozono K, Namba N, Inoue D, Okazaki R, Yamauchi M, Sugimoto T, Minagawa M, Michigami T, Nagai M, Matsumoto T. Nationwide survey of fibroblast growth factor 23 (FGF23)-related hypophosphatemic diseases in Japan: prevalence, biochemical data and treatment. Endocr J. 2015;62(9):811-6. doi: 10.1507/endocrj.EJ15-0275. Epub 2015 Jul 1. PubMed 26135520 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, 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
NCT04846647
Collaborators
DiaSorin ; Saluggia, Italia
Responsible party
Sponsor
First posted
Apr 15, 2021
Start date
Oct 5, 2021
Primary completion
Apr 25, 2022
Completion
Apr 25, 2022
Last update
May 11, 2023

Study contacts

Damien BOUVIER
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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