The FOP Connection 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.