Fibrous Dysplasia, McCune-Albright Syndrome Patient Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Fibrous Dysplasia; McCune Albright Syndrome; Mazabraud Syndrome

Detailed Description

The FD/MAS Patient Registry is an IRB approved research project that allows patients and families to share their experiences with fibrous dysplasia/McCune-Albright syndrome (FD/MAS) by completing a series of surveys.

The surveys were created in collaboration with patients, parents, clinicians and researchers, so that the data can be used to answer some of the most important questions about FD/MAS, including:

the way the disease develops over time (its "natural history"), the patient experience of the disease, and its impact on quality of life, how and when diagnoses are made, the scope of treatments in use, what surgical techniques work best, and for whom, what other medical interventions work best, and for whom, what social services and therapies are useful, the costs of care to patients and their families, issues that concern patients (such as the impact of pregnancy on FD, or children feeling different and facing stigma), and which research questions and support programs you think are important to fund.

Participation is free and convenient for people with FD/MAS and their legal guardians. You can join today at www.fdmasregistry.org.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Carmel Shemmesh-Rafalowsky; Email: PI.Registry@fibrousdysplasia.org

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20816-2558
      • Recruiting
      • Tovah Burstein
      • Contact: Tovah Burstein, MFA; Phone Number: 603-325-2489; Email: info@fibrousdysplasia.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample of all patients in these particular disease communities.

Description

Inclusion Criteria any one or more of the following:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
FD/MAS Patients; Patients with fibrous dysplasia and/or McCune-Albright syndrome and related disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tovah Burstein

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2016
• Primary Completion (ANTICIPATED): October 1, 2026
• Study Completion (ANTICIPATED): October 1, 2026

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (ACTUAL): July 27, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: McCune-Albright Syndrome; Fibrous Dysplasia; Mazabrauds; FD/MAS
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Osteochondrodysplasias; Syndrome; Hyperplasia; Fibrous Dysplasia of Bone; Fibrous Dysplasia, Polyostotic
• Other Study ID Numbers: Pro00018980.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No