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CompletedNCT03596554XLH 21Updated Oct 27, 2020

X-linked Hypophosphatemia and FGF21

An observational study in X-linked Hypophosphatemia, sponsored by Hospices Civils de Lyon. Completed at 3 sites in France. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-10-27.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
39
Ages
10 Years to 18 Years
Sex
All
01

Study summary

Fibroblast Growth Factor 23 and Fibroblast Growth Factor 21 are two endocrine Fibroblast Growth Factors, requiring Klotho as a co-factor to promote their systemic actions. Fibroblast Growth Factor 21 is involved in the regulation of glucid and lipid metabolism. Fibroblast Growth Factor 21 Knock Out mice display obesity and hyperglycemia.

In investigators experience, patients with X-linked hypophosphatemia often present with early-onset over-weight that could be partly explained by decreased physical activity because of bone pains and deformations after puberty; however, patients usually display progressive over-weight earlier in life, when there is no limitation of physical activity yet.

To the knowledge of investigators the association between Fibroblast Growth Factor 23, Fibroblast Growth Factor 21 and Klotho in patients with X-linked hypophosphatemia has never been evaluated. Thus, the main objective of this study is to evaluate the glucid and lipid metabolism in patients with X-linked hypophosphatemia, the main working hypothesis being that the genetic deregulation in the Fibroblast Growth Factor 23 axis in patients with X-linked hypophosphatemia induces modifications of Klotho levels (namely decreased levels) that in turn will deregulate the Fibroblast Growth Factor 21 axis (resistance to Fibroblast Growth Factor 21 because of decreased Klotho levels).

02

Conditions studied

  • X-linked Hypophosphatemia
03

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients aged 10 to 18 years followed in the different sites of the French Reference Center for Rare Diseases of Calcium and Phosphate, and monitored for hypophosphatemic rickets; estimated number to be included, N=40

Inclusion criteria

  • Child with X-linked hypophosphatemia with PHEX gene mutation
  • Child between 10 and 18 years old
  • Child over 10 kg having a blood sample as part of the treatment (due to regulatory constraints for blood volume taken in 30-day period of 40 mL in children over 10 kg)
  • Child and parent / holder of parental authority who has been informed of the study and does not object to participate.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy in progress
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
39 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherDescriptive study

    Description of the circulating values of Fibroblast Growth Factor 21 in X-linked hypophosphatemia children compared to controls in the VITADOS cohort (healthy children and adolescents aged 10-18 years), after age-matched, pubertal stage and sex).

05

What researchers measure

Primary outcomes

  1. Circulating FGF21

    Samples specific to the study will be collected during a sampling performed as part of the usual care and follow-up of the patient. An additional tube (5 ml maximum) will be collected, which will be sent to the Lyon Sud Hospital Center for analysis of circulating FGF21.

    Time frame: 1 day

06

Study locations

3 sites
  • Centre de Référence des Maladies Rénales Rares - Centre de Référence des Maladies Rares du Calcium et du Phosphate - Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant
    Bron, 69677, France
  • Centre de Référence des Maladies Rares du Calcium et du Phosphore, Service d'Endocrinologie Pédiatrique - Hôpital du Kremlin Bicêtre
    Paris, 94270, France
  • Endocrinologie, Maladies Osseuses, Gynécologie, Génétique, Hôpital des Enfants, CHU de Toulouse
    Toulouse, 31059, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03596554
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jul 24, 2018
Start date
Jan 11, 2019
Primary completion
Feb 27, 2020
Completion
Feb 27, 2020
Last update
Oct 27, 2020

Oversight

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

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