Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05312086
Other study ID # 2020-A01386-33
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 15, 2022
Est. completion date June 15, 2023

Study information

Verified date January 2022
Source Assistance Publique - Hôpitaux de Paris
Contact Agnés LINGLART, Pr
Phone 0145217116
Email agnes.linglart@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 20 typically developing children. The investigator will compare the percentage of IMAT in the XLH group versus control group and the difference concerning the intraMAT between the two groups.


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 structure and composition of muscles to those of muscles in children with XLH pathology (muscle MRI of XLH patients is performed as part of standard medical care). During this study we will have two groups: XLH group and a control group with typically developing children. In the XLH group, composed of 10 patients aged between 5 ans 17 years, female or male and ongoing growth (lesser bone age than 15 years old), have XLH and the most severe radiological deformities,clinical complications (pain and muscular weakness), have already done a muscle MRI of the lower limb during their follow-up. The control group composed of 20 healthy volunteers aged between 5 ans 17 years old, female or male and without any endocrine pathology. A muscle MRI is necessary for healthy volunteers. Every child will be alone After signing the informed consent by the 2 parents, the patient or the healthy volunteer and his parents, the MRI assessment will be performed on the same day. Performing the muscle MRI requires the cooperation of the child in order to remain lying down and motionless throughout the duration of the MRI, i.e. approximately 45 minutes. Performing MRI does not require the injection of contrast products or radiopharmaceuticals.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MRI
Performing the muscle MRI requires the cooperation of the child in order to remain lying down and motionless throughout the duration of the MRI, about 45 minutes. Performing MRI does not require the injection of contrast products or radiopharmaceuticals.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type Measure Description Time frame Safety issue
Primary Quantify and compare muscle composition in XLH children versus healthy control children to demonstrate a link between muscle function and muscle quality. calculation of inter-muscular adipose tissue will be done in cm2 1 day
Secondary Measurement of muscle strength on force platforms, during gait analysis. Power test by mechanography of the jump (bipod and monopodal). Grasping test and correlation of fatty infiltration and functional data. The Outcome Measure is BMI (Kg/m²) 1 day
Secondary Quantitative analysis of the muscles of the lower limbs (volume and length) The Outcome Measure is BMI (Kg/m²) 1 day
See also
  Status Clinical Trial Phase
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04207359 - Effects of Creatine Supplementation in Breast Cancer Survivors N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04076982 - Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians N/A
Not yet recruiting NCT03662555 - Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function N/A
Completed NCT02530723 - Functional Changes and Power Training in Older Women. N/A
Completed NCT01743495 - CAPABLE for Frail Dually Eligible Older Adults N/A
Completed NCT01704976 - SR-WBV Training for Frail Elderly in the Skilling up Stage N/A
Completed NCT00183040 - HORMA: Hormonal Regulators of Muscle and Metabolism in Aging Phase 2
Enrolling by invitation NCT06432062 - Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia
Recruiting NCT05073224 - Muscle Function After Childbirth N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT03810768 - Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Completed NCT00060970 - Evaluating Muscle Function After Ankle Surgery N/A
Completed NCT04546048 - The Early Strength Training Program in Post-transplant Liver Cases N/A
Completed NCT03628365 - Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients? N/A
Completed NCT05056298 - Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot N/A
Completed NCT02739464 - Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients N/A
Completed NCT05497960 - Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes N/A