The Fibrodysplasia Ossificans Progressiva (FOP) Registry
FOP Registry: A Global Registry for the Fibrodysplasia Ossificans Progressiva Community
1 other identifier
observational
800
1 country
1
Brief Summary
The Fibrodysplasia Ossificans Progressiva (FOP) Registry is a global, non-interventional, voluntary database that captures demographic and disease data directly from FOP patients and their caregivers via a secure, web-based patient portal. A physician portal (in development) will allow physicians to enter clinical data about their patients. The objectives are to organize the international FOP community for participation in clinical trials; to enable FOP patients worldwide to report data in a shared forum; to improve the collective understanding of FOP natural history; and to advance the understanding of FOP treatment outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 6, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2040
April 8, 2026
April 1, 2026
20.1 years
March 6, 2016
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Patient Reported Changes in New Bone Growth Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report changes in new bone growth among 27 joints and body locations.
Baseline, then every six months for up to 10 years
Patient Reported Changes in Episodic Flare-Ups Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report changes in episodic flare-ups among 27 joints and body locations.
Baseline, then every six months for up to 10 years
Patient Reported Changes in Mobility Using a Patient-Directed Survey Developed by the IFOPA
The patient is able to report changes in mobility among 27 joints and body locations.
Baseline, then every six months for up to 10 years
Secondary Outcomes (9)
Patient Reported Changes in Health Resource Utilization Using a Patient-Directed Survey Developed by the IFOPA
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Ear Using a Patient-Directed Survey Developed by the IFOPA
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Skin Using a Patient-Directed Survey Developed by the IFOPA
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Central Nervous System Using a Patient-Directed Survey Developed by the IFOPA
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Pulmonary System Using a Patient-Directed Survey Developed by the IFOPA
Baseline, then every six months for up to 10 years
- +4 more secondary outcomes
Other Outcomes (3)
Patient Reported Changes in Activities of Daily Living Using the FOP-Physical Functioning Questionnaire (PFQ)
Baseline, then every six months for up to 10 years
Patient Reported Changes in Overall Health Using the PROMIS Global Health Scale
Baseline, then every six months for up to 10 years
Patient Reported Changes in the Need for Assistive Devices, Aids, Attendants, and Adaptations Using a Survey Developed by the IFOPA
Baseline, then every six months for up to 10 years
Study Arms (1)
FOP Patients
None. IFOPA-REG-001 is a FOP patient observational registry study.
Eligibility Criteria
Individuals with Fibrodysplasia Ossificans Progressive (FOP) from the international FOP community will be invited to join the Registry.
You may qualify if:
- Participants must have a confirmed diagnosis of FOP.
- Participants (or a parent or legal guardian) must be willing and able to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The International Fibrodysplasia Ossificans Progressiva Association (IFOPA)
North Kansas City, Missouri, 064116, United States
Related Publications (1)
Pignolo RJ, Kimel M, Whalen J, Kawata AK, Artyomenko A, Kaplan FS. The Fibrodysplasia Ossificans Progressiva Physical Function Questionnaire (FOP-PFQ): A patient-reported, disease-specific measure. Bone. 2023 Mar;168:116642. doi: 10.1016/j.bone.2022.116642. Epub 2022 Dec 13.
PMID: 36526263DERIVED
Related Links
- Click here for more information about this study: The FOP Connection Registry
- The International FOP Association is a 501(c)(3) non-profit organization supporting medical research, education and communication for those afflicted by the rare genetic condition Fibrodysplasia Ossificans Progressiva (FOP).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Hamilton, PhD
International Fibrodysplasia Ossificans Progressiva Association
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2016
First Posted
April 20, 2016
Study Start
July 1, 2015
Primary Completion (Estimated)
July 31, 2035
Study Completion (Estimated)
December 31, 2040
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Formal data sharing agreements are planned between the International FOP Association and biopharmaceutical companies doing research in Fibrodysplasia Ossificans Progressiva (FOP). Publications are also planned with biopharmaceutical companies and physician researchers.