Understanding Hypophosphatasia in Adults with Rheumatology Issues
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.
This study is trying to learn more about adults with hypophosphatasia who have joint and bone issues to help improve how they are diagnosed and treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bonn Academic / other |
| Locations | 1 site (Bonn, North Rhine-Westphali) |
| Trial ID | NCT06574282 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the characteristics of adult patients with hypophosphatasia who present at rheumatology departments. It involves a multi-center approach to gather data on the prevalence of this rare genetic disorder and its musculoskeletal complaints. The study will also focus on developing an algorithm for diagnosing hypophosphatasia based on clinical findings and alkaline phosphatase levels. Participants will undergo a second measurement of alkaline phosphatase as part of the evaluation process.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a clinical suspicion of hypophosphatasia and evidence of low alkaline phosphatase levels.
Not a fit: Patients who do not exhibit clinical signs of hypophosphatasia or have normal alkaline phosphatase levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and understanding of hypophosphatasia in adults, enhancing patient care.
How similar studies have performed: While studies on hypophosphatasia exist, this specific approach focusing on adult patients in rheumatology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Age \> 18 years * Clinical suspicion of hypophosphatasia * Evidence of an abnormal ALP (ALP below LLN) within the clinical routine screening Exclusion Criteria: * Failure to meet the inclusion criteria listed above
Where this trial is running
Bonn, North Rhine-Westphali
- Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn — Bonn, North Rhine-Westphali, Germany (Recruiting)
Study contacts
- Principal investigator: Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr. — University Hospital of Bonn
- Study coordinator: Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.
- Email: rheumatologie@ukbonn.de
- Phone: +49 228 287-17000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.