HypophosphatasiaCOHIRnationalNCT06574282
Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study
An observational study of Hypophosphatasia, run by University of Bonn at 1 site in Germany.
Trial summary
Non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to HPP diagnosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypophosphatasia
- What is being tested?
- Second alkaline phosphatase measurement
- How many people
- 720 participants
- Where
- 1 siteGermany
- Study dates
- 25 Aug 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient presenting at the participating study site's rheumatology department with musculoskeletal complaints within the timeframe of the study conduct.
Who may be able to join
- Written informed consent
- Age > 18 years
- Clinical suspicion of hypophosphatasia
- Evidence of an abnormal ALP (ALP below LLN) within the clinical routine screening
Who cannot join
- Failure to meet the inclusion criteria listed above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
Bonn, North Rhine-Westphali, 53127
Valentin S. Schäfer, Univ.-Prof. Dr.med. MUDr., +49 228 287-17000, rheumatologie@ukbonn.de
Claus-Jürgen Bauer, MD, +49 228 287-17000, rheumatologie@ukbonn.de
About this study
Official title: The COHIR Multi-center Study - a Non-interventional, Prospective, Multi-center Investigation With Exploratory Data Analysis to Assess the Proportion of Patients With Hypophosphatasia Presenting at the Department of Rheumatology and Establishment of an Algorithm to HPP Diagnosis.
Non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to HPP diagnosis
Read the detailed description
Acronym: Expansion:
HPP =Hypophosphatasia COHIR ="Characteristics of Hypophosphatasia in Adult Patients in Rheumatology" ALPL =Alkaline Phosphatase
- Conditions
- Hypophosphatasia
- Being tested
- Second alkaline phosphatase measurement
- Keywords
- Hypophosphatasia, Hypophosphatasemia, Musculoskeletal complaints, Genetic disorder, Rare disease, Alkaline phosphatase gene, ALP, ALPL gene, Rheumatology, COHIR study, COHIR multi-center study, COHIRnational study, Prevalence, Diagnostic Algorithm, Metabolic bone diseases
- Medical subject headings
- Hypophosphatasia, Genetic Diseases, Inborn, Rare Diseases, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second alkaline phosphatase measurementDiagnostic test
(1-4 weeks after the 1st measurement)
| Study group | Role | What they receive |
|---|---|---|
| Persistant hypophosphatasemia | Not described Receives: Diagnostic Test: Second alkaline phosphatase measurement | |
| Transient hypophosphatasemia (Control group without hypophosphatasia) | Not described Receives: Diagnostic Test: Second alkaline phosphatase measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hypophosphatasia in adult patients in rheumatology
The primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients presenting with musculoskeletal symptoms in rheumatology.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start25 Aug 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophosphatasiaStudies 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
- Prospective
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentin Schäfer, University of Bonn
- Investigators
- Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr., Principal investigator, University Hospital of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574282
- Sponsor's protocol ID
- MED2-202002
- Acronym
- COHIRnational
- Status last verified
- Feb 2025
- First submitted
- 25 Aug 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COHIR Multi-center Study - a Non-interventional, Prospective, Multi-center Investigation With Exploratory Data Analysis to Assess the Proportion of Patients With Hypophosphatasia Presenting at the Department of Rheumatology and Establishment of an Algorithm to HPP Diagnosis.
- ClinicalTrials.gov ID
- NCT06574282
- Acronym / sponsor ID
- COHIRnational / MED2-202002
- Conditions
- Hypophosphatasia
- Keywords
- Hypophosphatasia, Hypophosphatasemia, Musculoskeletal complaints, Genetic disorder, Rare disease, Alkaline phosphatase gene, ALP, ALPL gene
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Aug 2024 (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.
Non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to HPP diagnosis
Detailed description
Acronym: Expansion:
HPP =Hypophosphatasia COHIR ="Characteristics of Hypophosphatasia in Adult Patients in Rheumatology" ALPL =Alkaline Phosphatase
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persistant hypophosphatasemia | – | Diagnostic Test: Second alkaline phosphatase measurement |
| Transient hypophosphatasemia (Control group without hypophosphatasia) | – | Diagnostic Test: Second alkaline phosphatase measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient presenting at the participating study site's rheumatology department with musculoskeletal complaints within the timeframe of the study conduct.
Key inclusion criteria (4 listed)
- Written informed consent
- Age > 18 years
- Clinical suspicion of hypophosphatasia
- Evidence of an abnormal ALP (ALP below LLN) within the clinical routine screening
Key exclusion criteria (1 listed)
- Failure to meet the inclusion criteria listed above
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 |
|---|---|---|
| Second alkaline phosphatase measurement(1-4 weeks after the 1st measurement) | Diagnostic test | Persistant hypophosphatasemia, Transient hypophosphatasemia (Control group without hypophosphatasia) |
Primary outcome
Prevalence of hypophosphatasia in adult patients in rheumatology
Time frame: 36 months
The primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients presenting with musculoskeletal symptoms in rheumatology.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
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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.
Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr. principal investigator
University Hospital of Bonn
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 Hypophosphatasia, run by University of Bonn at 1 site in Germany.
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 4 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr. (+49 228 287-17000, rheumatologie@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypophosphatasia in adult patients in rheumatology (time frame: 36 months). 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 Feb 2025.