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CompletedNCT04665323Updated May 21, 2021

An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.

An observational study in Fibrodysplasia Ossificans Progressiva, sponsored by Ipsen. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
411
Sex
All
01

Study summary

The FOP burden of illness (BoI) survey aims to assess the impact of the burden of FOP on patients and their families. The study is being conducted online and available for residents in Argentina, Brazil, Canada, France, Germany, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Sweden, the US, and the UK.

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Conditions studied

  • Fibrodysplasia Ossificans Progressiva

Browse trials for

03

In context

Myositis Ossificans

25 studies on the registry are indexed under Myositis Ossificans; 5 are open to participants now.

Browse Myositis Ossificans studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Convenience Sample

Inclusion criteria

  1. Individuals meeting one of the two categories below (A or B) are eligible to participate: A. Any individual with FOP, of any age; B. Any individual who is a family member of a person with FOP (i.e. either a parent / legal guardian or a sibling) and who is aged 18 years and older
  2. All adult participants and parents / legal guardians of minors should provide informed consent before starting filling out the survey

Exclusion criteria

Exclusion Criteria:

  1. Any individuals who are unable to complete the online survey independently or to get assistance to physically enter the answers
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
411 participants (actual)
Patient registry
No

Groups and cohorts

  • People living with FOP
  • Parent or legal guardian primary caregivers
  • Parent or legal guardian
  • Siblings
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What researchers measure

Primary outcomes

  1. Quality of life of people living with FOP and their family members, measured using the EuroQol health-related quality of life (QoL) questionnaire (EQ-5D-5L)

    Time frame: Baseline

  2. Quality of life of people living with FOP and their family members, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Baseline

  3. Caregiver burden for the parent primary caregiver, measured using the Zarit Burden Interview (ZBI)

    Time frame: Baseline

  4. Responses to bespoke questionnaire describing the emotional burden on family members

    Time frame: Baseline

  5. Physical function of the person living with FOP, measured using the FOP Physical Function Questionnaire (FOP-PFQ).

    Time frame: Baseline

  6. Joint function of the person living with FOP, measured using Patient-Reported Mobility Assessment (PRMA).

    Time frame: Baseline

  7. Responses to bespoke questionnaire describing the types of healthcare services utilized by the person living with FOP over the last two years

    Time frame: Baseline

  8. Responses to bespoke questionnaire describing the frequency of utilization of healthcare services by the person living with FOP over the last two years.

    Time frame: Baseline

  9. Responses to bespoke questionnaire describing the impact of FOP on modifications to the living environment (e.g. home modifications) and travels.

    Time frame: Baseline

  10. Responses to bespoke questionnaire describing the expenses paid by the family for the care of the person living with FOP

    Time frame: Baseline

  11. Responses to bespoke questionnaire describing the Impact of FOP on education, employment, and career choices for people living with FOP and their family members

    Time frame: Baseline

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Study locations

1 site
  • Ipsen Central Contact
    Cambridge, Massachusetts 02142, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04665323
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Jan 18, 2021
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
May 21, 2021

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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