The Fibrodysplasia Ossificans Progressiva (FOP) Registry

April 2, 2026 updated by: The International FOP Association

FOP Registry: A Global Registry for the Fibrodysplasia Ossificans Progressiva Community

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The 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. No experimental intervention is involved. 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.

The Registry collects data through two sources. First, the Patient Portal (launched in July 2015) allows FOP patients and caregivers to enter information about their experiences living with FOP. Second, the Physician Portal (in development) will allow physicians to enter clinical data about patients under their care. The Registry will be capable of including data on specific marketed therapies under the direction and control of a sponsoring pharmaceutical company. Key identifiers will link the physician-reported data with the Patient Portal data.

Participants must have a confirmed diagnosis of FOP and the participant (or a parent or legal guardian) must be willing and able to provide written informed consent. There are no exclusion criteria. Data collected in the Patient Portal include: patient demographics and diagnosis pathway; medical and dental care; clinical research participation and biospecimen donation; heterotopic ossification (bone growth and episodic flare-ups); other signs and symptoms by body system; patient-reported outcomes (physical functioning, pain, fatigue, and general health); and assistive devices, aids, attendants, and adaptations. Because the Registry is designed to accommodate participants along a broad spectrum of FOP disease severity, most of the data fields are optional, allowing participants a high degree of flexibility in how much information they contribute, which also minimizes participant burden.

After completing the informed consent, participants enter their baseline (historical) data. Participants will be encouraged to update their information at least twice per year. Participants may withdraw their consent at any time without prejudice or providing an explanation. The Registry has no pre-specified end date and will continue for as long as it is sustainable and useful to the FOP community.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • North Kansas City, Missouri, United States, 064116
        • Recruiting
        • The International Fibrodysplasia Ossificans Progressiva Association (IFOPA)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals with Fibrodysplasia Ossificans Progressive (FOP) from the international FOP community will be invited to join the Registry.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • There are no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
FOP Patients
None. IFOPA-REG-001 is a FOP patient observational registry study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Changes in New Bone Growth Using a Patient-Directed Survey Developed by the IFOPA
Time Frame: Baseline, then every six months for up to 10 years
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
Time Frame: Baseline, then every six months for up to 10 years
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
Time Frame: Baseline, then every six months for up to 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Changes in Health Resource Utilization Using a Patient-Directed Survey Developed by the IFOPA
Time Frame: Baseline, then every six months for up to 10 years
The number of visits to a Physician and a Dentist, as well as the number of hospitalizations and reasons for the hospitalizations, are used to assess health resource utilization.
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
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the ears.
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
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the skin.
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
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the central nervous system.
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
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the pulmonary system.
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Gastrointestinal System Using a Patient-Directed Survey Developed by the IFOPA
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the gastrointestinal system.
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Cardiovascular System Using a Patient-Directed Survey Developed by the IFOPA
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the cardiovascular system.
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Renal System Using a Patient-Directed Survey Developed by the IFOPA
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the renal system.
Baseline, then every six months for up to 10 years
Patient Reported Changes in Signs Related to the Endocrine System Using a Patient-Directed Survey Developed by the IFOPA
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to report new or continuing health issues related to the endocrine system.
Baseline, then every six months for up to 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Changes in Activities of Daily Living Using the FOP-Physical Functioning Questionnaire (PFQ)
Time Frame: Baseline, then every six months for up to 10 years
Baseline, then every six months for up to 10 years
Patient Reported Changes in Overall Health Using the PROMIS Global Health Scale
Time Frame: Baseline, then every six months for up to 10 years
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
Time Frame: Baseline, then every six months for up to 10 years
The patient is able to respond Yes or No to questions related to his/her need for Assistive Devices, Aids, Attendants, and Adaptations as a result of his/her FOP disease.
Baseline, then every six months for up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The International FOP Association

Investigators

  • Study Director: Mark Hamilton, PhD, International Fibrodysplasia Ossificans Progressiva Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Estimated)

July 31, 2035

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimated)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFOPA-REG-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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