Recruiting

Observational Study

Sponsor:

The International FOP Association

Code:

NCT02745158

Conditions

Fibrodysplasia Ossificans Progressiva (FOP)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Fibrodysplasia Ossificans Progressiva (FOP)

Study ID

NCT02745158

Start date

Jul, 2015

Status verified date

Apr, 2026

Completion date

Dec 31, 2040

Anticipated

Primary completion date

Jul 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

FOP Patients

None. IFOPA-REG-001 is a FOP patient observational registry study.

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Mark S Hamilton, PhD

1-203-605-2122mark.hamilton@ifopa.org

Sammi Kile, MS

1-720-341-6999registry@ifopa.org

Locations

The International Fibrodysplasia Ossificans Progressiva Association (IFOPA)

Recruiting

North Kansas City, Missouri, United States, 064116

Contacts

Mark S Hamilton, PhD

1-203-605=2122mark.hamilton@ifopa.org

Sammi Kile, MS

1-720-341-6999registry@ifopa.org

More Information

Sponsor

The International FOP Association

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Fibrodysplasia ossificans progressiva
  • FOP
  • International FOP Association
  • Patient Advocacy Group
  • Patient Registry
  • Natural History
  • Patient-Reported Outcomes
  • Observational Database
  • Bone Morphogenetic Protein
  • BMP
  • Bone Growth
  • Joint
  • Mobility
  • Flare-Up
  • Heterotopic Ossification
  • Ectopic Bone
  • Osteochondroma
  • Hallux Valgus
  • ALK2
  • ACVR1
  • Activin A
  • IFOPA
  • Activin A Receptor Type I
  • Activin Receptor-like Kinase-2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The International FOP Association on 2026-04-08.