Hypophosphatemia Without Immediate Anteriority Clinical Trial
— IFEHOfficial title:
Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia
| Verified date | May 2023 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.)
| Status | Completed |
| Enrollment | 260 |
| Est. completion date | April 25, 2022 |
| Est. primary completion date | April 25, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 informed consent to participate in research - Affiliated to a social security system Exclusion Criteria: - Previously diagnosed hypophosphatemia - Hypophosphatemia during hospitalisation - Haemodialysis patient - Refusal to participate |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Jean Perrin | Clermont-Ferrand | |
| France | Chu Clermont Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | DiaSorin ; Saluggia, Italia |
France,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the frequency of blood levels of FGF23 unsuitable for hypophosphatemia | Assessing the presence of a blood level of FGF23 considered unsuitable for hypophosphatemia | day 0 | |
| Secondary | 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 ...) | Day 1 | |
| Secondary | 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 ...). | day 1 |