- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06067932
Foot Disorders in X-linked Hypophosphatemia
October 5, 2023 updated by: Forian Wenzel-Schwarz, Orthopedic Hospital Vienna Speising
Mid- and Forefoot Disorders in Adolescents and Adults With X-linked Hypophosphatemia
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vienna, Austria, 1130
- Orthopedic Hospital Speising Vienna
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with rare bone disease (XLH) with and without foot problems
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of feet with signs of osteoarthritis
Time Frame: baseline
|
radiographic signs of osteoarthritis at the foot joints
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Gabriel Mindler, Dr, Orthopedic Hospital Speising Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
September 28, 2023
First Submitted That Met QC Criteria
September 28, 2023
First Posted (Actual)
October 5, 2023
Study Record Updates
Last Update Posted (Estimated)
October 9, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Nutrition Disorders
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Metabolism, Inborn Errors
- Bone Diseases, Metabolic
- Renal Tubular Transport, Inborn Errors
- Calcium Metabolism Disorders
- Metal Metabolism, Inborn Errors
- Phosphorus Metabolism Disorders
- Rickets
- Vitamin D Deficiency
- Rickets, Hypophosphatemic
- Hypophosphatemia, Familial
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Familial Hypophosphatemic Rickets
- Hypophosphatemia
Other Study ID Numbers
- Midfoot XLH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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