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

NCT ID: NCT06574282

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-25

Study Completion Date

2027-09-30

Brief Summary

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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

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Acronym: Expansion:

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

Conditions

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Hypophosphatasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Persistant hypophosphatasemia

Second alkaline phosphatase measurement

Intervention Type DIAGNOSTIC_TEST

(1-4 weeks after the 1st measurement)

Transient hypophosphatasemia (Control group without hypophosphatasia)

Second alkaline phosphatase measurement

Intervention Type DIAGNOSTIC_TEST

(1-4 weeks after the 1st measurement)

Interventions

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Second alkaline phosphatase measurement

(1-4 weeks after the 1st measurement)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bonn

OTHER

Sponsor Role lead

Responsible Party

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Valentin Schäfer

Univ.-Prof. Dr. med. MuDr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Bonn

Locations

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Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn

Bonn, North Rhine-Westphali, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.

Role: CONTACT

+49 228 287-17000

Claus-Jürgen Bauer, MD

Role: CONTACT

+49 228 287-17000

Facility Contacts

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Valentin S. Schäfer, Univ.-Prof. Dr.med. MUDr.

Role: primary

+49 228 287-17000

Claus-Jürgen Bauer, MD

Role: backup

+49 228 287-17000

Other Identifiers

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MED2-202002

Identifier Type: -

Identifier Source: org_study_id

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