What is the mechanism of action of this treatment?

Common treatments for Fibrous Dysplasia (FD) include bisphosphonates, which inhibit bone resorption by osteoclasts, and surgical interventions to correct deformities and fractures. Bisphosphonates help reduce bone pain and prevent fractures by stabilizing the bone matrix. Understanding these mechanisms is crucial for FD patients because it allows for targeted pain management strategies, improving quality of life. The trial focusing on pain mechanisms in FD/MAS aims to further elucidate the underlying causes of pain, which can lead to more effective and personalized treatment approaches.

What side effects are associated with this type of intervention?

Common treatments for managing pain in Fibrous Dysplasia (FD) include bisphosphonates, analgesics, and sometimes surgical interventions. Bisphosphonates, such as pamidronate or zoledronic acid, can help reduce bone pain but may cause side effects like gastrointestinal discomfort, flu-like symptoms, and, rarely, osteonecrosis of the jaw. Analgesics, including NSAIDs and acetaminophen, are frequently used but can lead to gastrointestinal issues, liver toxicity, or kidney problems with long-term use. Surgical interventions, aimed at correcting deformities or fractures, carry risks such as infection, blood loss, and complications related to anesthesia.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Fibrous Dysplasia (FD) mentioned in the provided context. However, pain management is a critical aspect of treating FD/MAS, as pain is a common and debilitating symptom. Current strategies focus on understanding the underlying mechanisms of pain in FD/MAS to improve patient outcomes. Patients and healthcare providers often use a combination of clinical and biological assessments to tailor pain management approaches.

What other types of research exist?

Promising novel alternatives for treating pain in FD/MAS patients include the use of bisphosphonates, which have shown potential in stabilizing bone lesions and reducing pain. Additionally, targeted therapies such as denosumab, an anti-RANKL antibody, may offer benefits by inhibiting bone resorption. Low-dose radiation therapy and the use of analgesics tailored to individual pain profiles are also being explored. These options should be discussed with a healthcare provider to tailor the best approach for each patient.

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Neuroimaging for Pain in Fibrous Dysplasia

N/A

Waitlist Available

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

10-45 years of age

Diagnosis of Fibrous Dysplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 50-60 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial uses advanced imaging and blood tests to study pain in FD/MAS patients. It focuses on understanding brain activity, muscle-bone interactions, mental health, and long-term effects to find better pain management strategies.

Who is the study for?

This trial is for English-speaking individuals aged 10-45 with a diagnosis of Fibrous Dysplasia. It's open to both male and female participants, including minors if they have parental assistance for consent.

What is being tested?

The study uses advanced imaging techniques like MRI-based neuroimaging, non-contrast MRI, and two types of PET/CT scans (18F-NaF and 18F-FDG) to investigate the causes of pain in patients with Fibrous Dysplasia.

What are the potential side effects?

While the interventions are primarily diagnostic imaging procedures that are generally safe, potential side effects may include discomfort during scanning, allergic reactions to tracers used in PET/CT scans, or exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 45 years old.

Select...

I have been diagnosed with Fibrous Dysplasia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 50-60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~50-60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 50-60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

% signal difference in BOLD signal

Secondary study objectives

Numerical clinical pain rating score

Other study objectives

18F-FDG or 18F-NaF uptake in FD lesion site

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment1 Intervention

20, matched healthy controls

Group II: Fibrous Dysplasia/McCune-Albright SyndromeExperimental Treatment4 Interventions

20, Fibrous Dysplasia/McCune-Albright Syndrome Patients with or without pain

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Non-contrast MRI

2018

N/A

~100

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Fibrous Dysplasia (FD) include bisphosphonates, which inhibit bone resorption by osteoclasts, and surgical interventions to correct deformities and fractures. Bisphosphonates help reduce bone pain and prevent fractures by stabilizing the bone matrix. Understanding these mechanisms is crucial for FD patients because it allows for targeted pain management strategies, improving quality of life. The trial focusing on pain mechanisms in FD/MAS aims to further elucidate the underlying causes of pain, which can lead to more effective and personalized treatment approaches.

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