Status:
UNKNOWN
Muscle Abnormalities in Children With XLH
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Muscle Weakness
XLH
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief Summary
XLH rickets is a rare disease with muscle weakness. Fat parameters such as IMAT and intraMAT could be increased in this disease. IMAT and intraMAT will be calculated on MRI for 11 XLH children versus ...
Detailed Description
Single-center, prospective, non-randomized, controlled study with XLH and healthy volunteer children. This study involves performing muscle MRI in healthy child volunteers to assess and compare the s...
Eligibility Criteria
Inclusion
- Inclusion Criteria common criteria to the 2 groups:
- Age: between 5 and 17 years.
- Sex: male or female.
- Informed consent, signed by both parents or holder of parental autority after being informated of the study.
- Affiliation to a social security schema or having the right to.
- Inclusion criteria for XLH Patients :
- Patient suffer of X-linked hypophosphatemia rickets.
- Severity of clinical and radiological damage (pain, muscle weakness and severe bone deformities).
- Growth in progress (bone age less than 15 years).
- Child under conventional treatment: patient responding to conventional treatment or
- under treatment with Burosumab (patient in treatment failure under treatment conventional).
- incluion criteria for helthy volunteers :
- Healthy voluntary subjects, not suffering from XLH.
- Matching by age (+/- 6 months) and sex.
- Exclusion Criteria common to the 2 groups :
- Not being able to stay still during the MRI examination (approximately 45 min).
- Growth completed.
- History of lower limb surgery.
- Contraindications to MRI
- Holders of parental authority under AME.
- Holders of parental authority under tutorship / curatorship.
- Exclusion criteria for Healthy volunteers :
- Patients with endocrine, contracted or muscular pathology.
- Patient receives a long-term treatment.
- Patients with a high athletic level.
- BMI-IOTF \<20 or\> 27.8
Exclusion
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05312086
Start Date
April 15 2022
End Date
June 15 2023
Last Update
April 5 2022
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