ClinicalTrials.gov record NCT06574282

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationGermany
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective, non-interventional study looks for hypophosphatasia among adults who come to rheumatology clinics with musculoskeletal complaints. It uses routine clinical data and a repeat alkaline phosphatase (ALP) measurement 1–4 weeks after an initial low ALP to distinguish persistent from transient low ALP. The study aims to measure how common HPP is in this group and to develop a diagnostic algorithm.

What it is studying. Whether hypophosphatasia is present in adult patients seen in rheumatology for musculoskeletal symptoms, and whether routine data including a second ALP measurement can be used to create an algorithm to help diagnose HPP.

What the researchers hope to learn. To estimate the prevalence of hypophosphatasia among adult rheumatology patients with musculoskeletal complaints and to develop an algorithm to aid diagnosis of HPP.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • Second alkaline phosphatase measurement

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a non-interventional study using routine clinical care. After giving written consent, participants will have a second alkaline phosphatase (ALP) blood test about 1–4 weeks after the first low ALP result; that second test is used to classify persistent versus transient low ALP. Study staff will collect routine clinical information from rheumatology visits for analysis. Participants may be followed as part of the study for up to 36 months.

How the study is structured. Non-interventional, prospective, multi-center observational cohort. Adults presenting to participating rheumatology departments with musculoskeletal complaints are followed using routine clinical care data. If an initial ALP (alkaline phosphatase) result is below the laboratory's lower limit of normal, a second ALP measurement is done 1–4 weeks later to identify persistent versus transient low ALP. Data will be analyzed over the study period to estimate prevalence and build a diagnostic algorithm.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on hypophosphatasia

Clinical trials9 trials listed for hypophosphatasiaEvery trial the registry lists for hypophosphatasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hypophosphatasia researchLatest monthly update: September 2026. Includes: Early lab flag. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 25, 2024
Primary completion
September 2027 (estimated)
Study completion
September 2027 (estimated)
Target enrollment
720 participants (estimated)
Last updated on registry
Feb 10, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Bonn
Principal investigator
Valentin Schäfer, Univ.-Prof. Dr. med. MuDr.
University of Bonn

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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