X-linked HypophosphatemiaNCT06067932
Foot Disorders in X-linked Hypophosphatemia
An observational study of X-linked Hypophosphatemia, run by Orthopedic Hospital Vienna Speising at 1 site in Austria.
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 Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- X-linked Hypophosphatemia
- What is being tested?
- Foot X rays and Clinical examination + scores
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2020to 1 Jul 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rare bone disease (XLH) with and without foot problems
Who may be able to join
None listed.
Who cannot join
- Exclusion criteria were other forms of hypophosphatemia, pregnancy and recent lower limb surgery within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- X-linked Hypophosphatemia
- Being tested
- Foot X rays, Clinical examination + scores
- Keywords
- foot and ankle
- Medical subject headings
- Familial Hypophosphatemic Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot X raysRadiation
Radiographs of ankle and foot anteroposterior/dorsoplantar were taken in standing position with a centralized beam on the ankle joint.
Clinical examination + scoresDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of feet with signs of osteoarthritis
radiographic signs of osteoarthritis at the foot joints
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-linked HypophosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Orthopedic Hospital Vienna Speising
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forian Wenzel-Schwarz, Orthopedic Hospital Vienna Speising
- Investigators
- Gabriel Mindler, Dr, Study chair, Orthopedic Hospital Speising Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067932
- Sponsor's protocol ID
- Midfoot XLH
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid- and Forefoot Disorders in Adolescents and Adults With X-linked Hypophosphatemia
- ClinicalTrials.gov ID
- NCT06067932
- Acronym / sponsor ID
- Midfoot XLH
- Conditions
- X-linked Hypophosphatemia
- Keywords
- foot and ankle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Orthopedic Hospital Vienna SpeisingUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rare bone disease (XLH) with and without foot problems
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Exclusion criteria were other forms of hypophosphatemia, pregnancy and recent lower limb surgery within 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot X raysRadiographs of ankle and foot anteroposterior/dorsoplantar were taken in standing position with a centralized beam on the ankle joint. | Radiation | – |
| Clinical examination + scoresThe 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 | Diagnostic test | – |
Primary outcome
Number of feet with signs of osteoarthritis
Time frame: baseline
radiographic signs of osteoarthritis at the foot joints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for X-linked Hypophosphatemia
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Active, not recruitingObservational study
X-linked Hypophosphatemia Disease Monitoring Program
X-linked Hypophosphatemia, Hypophosphatemic Rickets
Recruiting
Phosphorus-31 Spectroscopy in Phosphate Diabetes
Phosphate Diabetes, X-linked Hypophosphatemia
RecruitingObservational study
Registry for Patients With X-Linked Hypophosphatemia
X-Linked Hypophosphatemia
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Mindler, Dr study chair
Orthopedic Hospital Speising Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of X-linked Hypophosphatemia, run by Orthopedic Hospital Vienna Speising at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of feet with signs of osteoarthritis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.