Hypophosphatemia Without Immediate AnteriorityIFEHNCT04846647
Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia
An observational study of Hypophosphatemia Without Immediate Anteriority and Unexplained Hypophosphatemia, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypophosphatemia Without Immediate Anteriority, Unexplained Hypophosphatemia
- What is being tested?
- unexplained hypophoshatemia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 260 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Oct 2021to 25 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Major patient, male or female with hypophosphatemia (< 0.80 mmol/L), without immediate anteriority
Who may be able to join
- 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
Who cannot join
- Previously diagnosed hypophosphatemia
- Hypophosphatemia during hospitalisation
- Haemodialysis patient
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Centre Jean Perrin
Clermont-Ferrand
About this study
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.
- Being tested
- unexplained hypophoshatemia
- Keywords
- FGF-23, Unexplained hypophosphatemia, Phosphate metabolism, Physiopathology of hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unexplained hypophoshatemiaBehavioural
Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care.
| Study group | Role | What they receive |
|---|---|---|
| Unexplained hypophosphatemia | Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care. Receives: Behavioral: unexplained hypophoshatemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the frequency of blood levels of FGF23 unsuitable for hypophosphatemia
Assessing the presence of a blood level of FGF23 considered unsuitable for hypophosphatemia
Measured: day 0
Secondary outcomes (2)
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 ...)
Measured: Day 1
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 ...).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start5 Oct 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypophosphatemia Without Immediate AnteriorityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- DiaSorin ; Saluggia, Italia
- Responsible party
- Sponsor
- Investigators
- Damien BOUVIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846647
- Sponsor's protocol ID
- RNI 2021 BOUVIER
- Other IDs
- 2021-A00284-37
- Acronym
- IFEH
- Status last verified
- May 2023
- First submitted
- 13 Apr 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 25944690Imel 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 31485552Endo 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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia
- ClinicalTrials.gov ID
- NCT04846647
- Acronym / sponsor ID
- IFEH / RNI 2021 BOUVIER
- Keywords
- FGF-23, Unexplained hypophosphatemia, Phosphate metabolism, Physiopathology of hypophosphatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- DiaSorin ; Saluggia, Italia
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unexplained hypophosphatemia | – | Behavioral: unexplained hypophoshatemiaCollection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient, male or female with hypophosphatemia (< 0.80 mmol/L), without immediate anteriority
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Previously diagnosed hypophosphatemia
- Hypophosphatemia during hospitalisation
- Haemodialysis patient
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unexplained hypophoshatemiaCollection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care. | Behavioural | Unexplained hypophosphatemia |
Primary outcome
Evaluate the frequency of blood levels of FGF23 unsuitable for hypophosphatemia
Time frame: day 0
Assessing the presence of a blood level of FGF23 considered unsuitable for hypophosphatemia
2 secondary outcomes
Investigate the relationship between blood levels of FGF23 and other biochemical parameters in hospital patients with hypophosphatemia..
Time frame: Day 1
Investigate the relationship between blood levels of FGF23 and other biochemical parameters in hospital patients with hypophosphatemia.
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 25944690Suvannasankha 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.
- Background: PubMed 31485552Imel 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.
- Background: PubMed 26135520Endo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien BOUVIER principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypophosphatemia Without Immediate Anteriority and Unexplained Hypophosphatemia, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the frequency of blood levels of FGF23 unsuitable for hypophosphatemia (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846647, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.