An observational study in Fibrodysplasia Ossificans Progressiva (FOP), sponsored by The International FOP Association. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by The International FOP Association · Observational
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.
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.
24 studies on the registry are indexed under Myositis Ossificans; 5 are open to participants now.
Browse Myositis Ossificans studies →This is the only study on the registry with The International FOP Association as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Individuals with Fibrodysplasia Ossificans Progressive (FOP) from the international FOP community will be invited to join the Registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
None. IFOPA-REG-001 is a FOP patient observational registry study.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, then every six months for up to 10 years
Patient Reported Changes in Health Resource Utilization Using a Patient-Directed Survey Developed by the IFOPA
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.
Time frame: 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
The patient is able to report new or continuing health issues related to the ears.
Time frame: 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
The patient is able to report new or continuing health issues related to the skin.
Time frame: 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
The patient is able to report new or continuing health issues related to the central nervous system.
Time frame: 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
The patient is able to report new or continuing health issues related to the pulmonary system.
Time frame: 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
The patient is able to report new or continuing health issues related to the gastrointestinal system.
Time frame: 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
The patient is able to report new or continuing health issues related to the cardiovascular system.
Time frame: 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
The patient is able to report new or continuing health issues related to the renal system.
Time frame: 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
The patient is able to report new or continuing health issues related to the endocrine system.
Time frame: Baseline, then every six months for up to 10 years
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
Patient Reported Changes in Overall Health Using the PROMIS Global Health Scale
Time frame: 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
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.
Time frame: Baseline, then every six months for up to 10 years
Plan to share: Yes — 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.
Started Jul 2015 (actual). Primary completion is estimated for Jul 2035, 240 months after the start.
How these figures are worked out, and which studies are left out of them.
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Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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