Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO)
REG-HYPO
1 other identifier
observational
130
1 country
11
Brief Summary
The purpose of this study is to assess medical events during follow-up of adult patients having hypophosphatasia and consulting rheumatologists.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2023
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedStudy Start
First participant enrolled
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
ExpectedDecember 16, 2025
December 1, 2025
2.9 years
October 24, 2022
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Characterise the circumstances of diagnosis, and deduce ways to reduce the diagnostic delay of hypophosphatasia in adults.
Time since first symptom due to hypophosphatasia
At inclusion
Secondary Outcomes (4)
Characterise "non bony" forms: chondrocalcinosis, multiple tendon calcifications, inflammatory pseudo-rheumatism, odonto-HPP
At inclusion
Characterise the forms for which the genetic analysis is negative
At inclusion
Recognise situations of associated osteoporosis.
At 72 months
Characterise the practical follow-up of asfotase alpha treatment started in adults
At 72 months
Interventions
Collection data from diagnostic Data collected following to medical exam as part of care
Eligibility Criteria
Patients with hypophosphatasia discovered in adulthood.
You may qualify if:
- men and women,
- aged 18 and over, with no upper age limit, who have had a total alkaline phosphatase value of less than 40 IU/l on at least 3 occasions, or at least a total alkaline phosphatase value below 40 IU/L and evidence of ALPL gene polymorphism
- with at least one rheumatological symptom.
You may not qualify if:
- transient hypophosphatasia: absence of confirmation of a value below 40 IU/l on at least 3 samples, lack of genetic confirmation
- secondary hypophosphatasia according to the expert rheumatologist (drugs, endocrine disease, other genetic disease...).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
CHU de Bordeaux- Hôpital Pellegrin Place Amélia Raba Léon - 12è étage - Rhumatologie -
Bordeaux, France, 33076, France
CHU Lille
Lille, 59000, France
Hospices Civils de Lyon
Lyon, 69003, France
CHU Nice
Nice, France
Lariboisière Hospital
Paris, 75010, France
Cochin Hospital
Paris, 75014, France
CHU Poitiers
Poitiers, 86000, France
CHU Rennes
Rennes, 35000, France
CHU Saint-Etienne
Saint-Priest-en-Jarez, 42270, France
Les hôpitaux universitaires de Strasbourg
Strasbourg, 67200, France
CHU de Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christian ROUX, MD, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2022
First Posted
October 27, 2022
Study Start
March 22, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
March 1, 2031
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share