Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study (COHIRnational)

February 5, 2025 updated by: Valentin Schäfer, University of Bonn

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acronym: Expansion:

HPP =Hypophosphatasia COHIR ="Characteristics of Hypophosphatasia in Adult Patients in Rheumatology" ALPL =Alkaline Phosphatase

Study Type

Observational

Enrollment (Estimated)

720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.
  • Phone Number: +49 228 287-17000
  • Email: rheumatologie@ukbonn.de

Study Contact Backup

Study Locations

  • Germany
    • North Rhine-Westphali
      • Bonn, North Rhine-Westphali, Germany, 53127
        • Recruiting
        • Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Any adult patient presenting at the participating study site's rheumatology department with musculoskeletal complaints within the timeframe of the study conduct.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Persistant hypophosphatasemia
Diagnostic test: Second alkaline phosphatase measurement
(1-4 weeks after the 1st measurement)
Transient hypophosphatasemia (Control group without hypophosphatasia)
Diagnostic test: Second alkaline phosphatase measurement
(1-4 weeks after the 1st measurement)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bonn

Investigators

  • Principal Investigator: Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr., University Hospital of Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 25, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED2-202002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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