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NCT06067932 Clinical Trial

Foot Disorders in X-linked Hypophosphatemia

X-linked Hypophosphatemia Clinical Trial

Official title:
Mid- and Forefoot Disorders in Adolescents and Adults With X-linked Hypophosphatemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06067932
Other study ID # Midfoot XLH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date July 1, 2021

Study information
Verified date October 2023
Source Orthopedic Hospital Vienna Speising
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aimed to characterize foot pathologies using X-rays and clinical examination and assess related outcome scores in adolescents and adults with X-linked Hypophophatemia

Description:

A single center, cross-sectional analysis of adolescent and adult patients with XLH with and without previous surgical intervention was performed at the Orthopaedic Hospital Speising, Vienna, Austria. Clinical examination, quality of life questionnaires and radiographic data of foot x-rays in standing position were collected. Radiographic evaluation was performed to analyze foot deformity as well as signs of osteoarthritis at the foot.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 100 Years
Eligibility Inclusion Criteria: - Patients with confirmed XLH, = 16 years were invited to participate in this study Exclusion Criteria: - Exclusion criteria were other forms of hypophosphatemia, pregnancy and recent lower limb surgery within 3 months.

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Foot X rays
Radiographs of ankle and foot anteroposterior/dorsoplantar were taken in standing position with a centralized beam on the ankle joint.
Diagnostic Test:
• Clinical examination + scores
The American Orthopedic Foot and Ankle Society Score (AOFAS- midfoot section and 1st Forefoot ray, Forefoot ray 2-5) and the foot function index (FFI) were assessed

Locations
Country Name City State
Austria Orthopedic Hospital Speising Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Orthopedic Hospital Vienna Speising

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of feet with signs of osteoarthritis radiographic signs of osteoarthritis at the foot joints baseline
See also
  Status Clinical Trial Phase
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Recruiting NCT03879915 - Dental Implants in Patients With X-linked Hypophosphatemia
Active, not recruiting NCT03193476 - Registry for Patients With X-Linked Hypophosphatemia
Completed NCT02526160 - Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH) Phase 3
Completed NCT05181839 - A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
Completed NCT04146935 - Examining the Effect of Burosumab on Muscle Function Phase 4
Completed NCT02750618 - Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH) Phase 2
Active, not recruiting NCT03745521 - Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners
Completed NCT03920072 - Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH Phase 3
Recruiting NCT03748966 - Calcitriol Monotherapy for X-Linked Hypophosphatemia Early Phase 1
Recruiting NCT04419363 - Burosumab in Children and Adolescents With X-linked Hypophosphatemia Phase 4
Completed NCT02163577 - Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH) Phase 2
Active, not recruiting NCT03651505 - X-linked Hypophosphatemia Disease Monitoring Program
Completed NCT04695860 - Anti-FGF23 (Burosumab) in Adult Patients With XLH Phase 3
Completed NCT02312687 - Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH) Phase 2
Completed NCT03596554 - X-linked Hypophosphatemia and FGF21
Recruiting NCT03820518 - Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia Phase 4
Completed NCT01571596 - An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia Phase 1/Phase 2
Completed NCT04273490 - Characterising Pain, QoL, Body Composition, Arterial Stiffness, Muscles and Bones in Adult Persons With XLH and Healthy Controls
Completed NCT03489993 - FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)