Actively Recruiting
The COHIR Multi-center Study to Assess Hypophosphatasia in Adult Rheumatology Patients and Develop a Diagnostic Algorithm
Led by University of Bonn · Updated on 2025-02-10
720
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a non-interventional, prospective, multi-center study to explore the occurrence of hypophosphatasia (HPP) among adult patients who visit rheumatology departments. The study aims to better understand the characteristics of HPP in this population and to develop a diagnostic algorithm to help identify the condition. This investigation involves collecting and analyzing data without altering patient care. Participants will undergo diagnostic tests, including a second alkaline phosphatase (ALP) measurement taken 1 to 4 weeks after the initial test. Patients are grouped based on whether they have persistent low ALP levels indicating HPP or transient low ALP levels as a control group without HPP. This approach helps researchers assess the prevalence and patterns of HPP in rheumatology patients. During the study, participants will provide informed consent and be monitored over a 36-month period to determine the prevalence of HPP. The study involves routine clinical assessments and laboratory tests, focusing on ALP levels. Data collected will assist in establishing an algorithm to improve diagnosis of HPP in adults. The study started in August 2024 and is expected to continue until September 2027.
CONDITIONS
Brief Title
Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age > 18 years
- Clinical suspicion of hypophosphatasia
- Evidence of an abnormal alkaline phosphatase (ALP) level below the lower limit of normal during clinical screening
You will not qualify if you...
- Failure to meet the inclusion criteria listed above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 4 weeks
Participants undergo alkaline phosphatase measurements to assess for hypophosphatasia.
2 visits for alkaline phosphatase measurements
Duration - 36 months
Participants are observed to determine the prevalence of hypophosphatasia over time.
Periodic visits depending on participant schedule
Trial Site Locations
Total: 1 location
1
Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
Bonn, North Rhine-Westphali, Germany, 53127
Actively Recruiting
Research Team
V
Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.
C
Claus-Jürgen Bauer, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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