Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161142
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-07-03
Brief Title:
Characteristics of Hypophosphatasia in Adult Patients in Rheumatology
Sponsor:
University of Bonn
Organization:
University of Bonn
Study Overview
Official Title:
The COHIR Study - a Non-interventional Prospective Single-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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COHIR
Brief Summary:
With hypophosphatasia still being frequently overlooked and misdiagnosed the primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients in rheumatology and beyond that to establish an algorithm that promotes early hypophosphatasia detection in clinical practice
Detailed Description:
Hypophosphatasia HPP is a rare genetic disorder 1-3300000 severe cases in Europe caused by one or more mutations in the alkaline phosphatase ALP gene Hypomineralization results in symptoms such as arthralgias insufficiency fractures and poor dental status beginning in childhood A fatal outcome is conceivable in circumstances of early infancy first presentation In consistency with the musculoskeletal complaint pattern HPP is far more common in the rheumatology patient population than in the general population
However HPP is still frequently misdiagnosed as some other form of bone disease eg rickets osteomalacia or osteoporosis Therefore implementation of a clinically applicable algorithm for early hypophosphatasia detection is needed
The primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients in rheumatology Moreover a further goal is to establish an algorithm that reliably separates adult HPP patients from other rheumatologic and bone diseases
However HPP is still frequently misdiagnosed as some other form of bone disease eg rickets osteomalacia or osteoporosis Therefore implementation of a clinically applicable algorithm for early hypophosphatasia detection is needed
The primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients in rheumatology Moreover a further goal is to establish an algorithm that reliably separates adult HPP patients from other rheumatologic and bone diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None