Foot Disorders in X-linked Hypophosphatemia | NCT06067932

Studies
Foot Disorders in X-linked Hypophosphatemia

NCT06067932

Sponsor

Orthopedic Hospital Vienna Speising

Status

Completed

Last Update Posted

Oct 10, 2023Actual

Enrollment

28Actual

Phase

Not provided

Conditions

X-linked Hypophosphatemia

Interventions

Foot X rays
Clinical examination + scores

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Sep 28, 2023

First Submission Date that Met QC Criteria

Sep 28, 2023

First Posted Date

Oct 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2023

Last Update Posted Date

Oct 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Forian Wenzel-Schwarz, Orthopedic surgeon, Orthopedic Hospital Vienna SpeisingPrincipal Investigator

Lead Sponsor

Orthopedic Hospital Vienna SpeisingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Foot X rays	Radiation	Radiographs of ankle and foot anteroposterior/dorsoplantar were taken in standing position with a centralized beam on the ankle joint.
Clinical examination + scores	Diagnostic Test	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of feet with signs of osteoarthritis	radiographic signs of osteoarthritis at the foot joints	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with rare bone disease (XLH) with and without foot problems

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel Mindler, Dr	Orthopedic Hospital Speising Vienna	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopedic Hospital Speising Vienna		Vienna		1130	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053098	Familial Hypophosphatemic Rickets

Ancestor Terms

ID	Term
D063730	Rickets, Hypophosphatemic
D012279	Rickets
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010808	Physical Examination

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided