NCT03231644

Brief Summary

The FD/MAS Patient Registry is an IRB-approved research study that that invites the patients and families to help answer some of the biggest questions about FD/MAS by completing questionnaires about their lives with FD or MAS. Have you enrolled in the FD/MAS Patient Registry yet? Are you up-to-date on your surveys? Take a trip to www.fdmasregistry.org today to learn more about the project, enroll, complete your surveys, or make sure you aren't due to provide more info! The FD/MAS Patient Registry: Your story powers research.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2016Oct 2028

Study Start

First participant enrolled

October 31, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

11.9 years

First QC Date

July 20, 2017

Last Update Submit

August 7, 2025

Conditions

Keywords

Fibrous DysplasiaMcCune-Albright SyndromeMazabraudsFD/MAS

Outcome Measures

Primary Outcomes (6)

  • Treatment satisfaction

    FACIT-Treatment Satisfaction scale

    Through study completion, an average of every 2 years

  • Perceived symptoms of pain

    Brief Pain Inventory

    Through study completion, an average of every 2 years

  • Depression/anxiety

    Hospital Anxiety Depression Scale

    Through study completion, an average of every 2 years

  • Stigma

    NeuroQol Pediatric and Adult Stigma short forms

    Through study completion, an average of every 2 years

  • Health-related Quality of Life

    SF-36,PedsQL 4.0

    Through study completion, an average of every 2 years

  • Financial health

    FACIT-Cost

    Through study completion, an average of every 2 years

Study Arms (1)

FD/MAS Patients

Patients with fibrous dysplasia and/or McCune-Albright syndrome and related disorders.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample of all patients in these particular disease communities.

You may qualify if:

  • clinical diagnosis of fibrous dysplasia
  • clinical diagnosis of McCune-Albright syndrome
  • clinical diagnosis of Mazabraud's syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tovah Burstein

Bethesda, Maryland, 20816-2558, United States

RECRUITING

MeSH Terms

Conditions

Fibrous Dysplasia of BoneFibrous Dysplasia, Polyostotic

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Carmel Shemmesh-Rafalowsky

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Community Engagement Director

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 27, 2017

Study Start

October 31, 2016

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations