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Monoclonal Antibodies
Denosumab for Fibrous Dysplasia
Phase 2
Waitlist Available
Led By Alison M Boyce, M.D.
Research Sponsored by National Institute of Dental and Craniofacial Research (NIDCR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of Fibrous Dysplasia
Ability to understand and provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months
Awards & highlights
Study Summary
This trial is a single-center, open-label study of the effects of denosumab on bone turnover in people with fibrous dysplasia.
Who is the study for?
Adults over 18 with confirmed fibrous dysplasia and chronic bone pain, who have reached skeletal maturity. They must not have used denosumab or bisphosphonates in the past year, be willing to take supplements, use two forms of contraception if applicable, and cannot be pregnant or planning pregnancy within five months post-study.Check my eligibility
What is being tested?
The trial tests Denosumab's effects on bone turnover in fibrous dysplasia patients. It involves monthly doses for six months followed by an eight-month observation period. The study measures changes in bone markers, lesion intensity via PET/CT scans, and FD-related pain levels.See study design
What are the potential side effects?
Denosumab may cause low calcium levels, skin rash or eczema, infections due to weakened immune system response (like sinusitis), potential harm to jaw bones (osteonecrosis), muscle pain or spasms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Fibrous Dysplasia.
Select...
I understand the study and can give my consent.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary:1. Assessment of markers of bone turnover: Beta-crosslaps, C-telopeptides (bone resorption marker,Procollagen-1-propeptide (bone formation marker)
Secondary outcome measures
#1- Bone histomorphometric indices: (SqrRoot) Mineralized perimeter, (SqrRoot) Bone formation rate (SqrRoot) Cortical width (SqrRoot) Cortical area (SqrRoot) Osteoid width...
Exploratory Endpoint # 1. Effect of denosumab initiation and discontinuation on(SqrRoot) Serum calcium, phosphorus and parathyroid hormone (SqrRoot) Serum circulating RANKL and osteoprotegerin (OPG), and RANKL/OPG level...
Exploratory endpoint #2 - Denosumab discontinuation effect on:(SqrRoot) Biochemical markers of bone metabolism: beta-crosslaps C-telopeptides, procollagen-1 propeptide, bone specific alkaline phosphatase, osteocalcin, NTX-telopeptides
+3 moreSide effects data
From 2022 Phase 4 trial • 37 Patients • NCT0402625644%
joint pain
22%
nausea
22%
propagation of fracture at biopsy site
11%
dizziness
11%
rhinorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab Only
Teriparatide Only
Denosumab and Teriparatide
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Denosumab will be administered at 120 mg per dose every 4 weeks for six months, with loading doses on days 8 and 15 of month 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2013
Completed Phase 4
~12010
Find a Location
Who is running the clinical trial?
National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor
300 Previous Clinical Trials
848,335 Total Patients Enrolled
Alison M Boyce, M.D.Principal InvestigatorNational Institute of Dental and Craniofacial Research (NIDCR)
3 Previous Clinical Trials
530 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had bone pain for at least 3 months in an area affected by FD.I am 18 years old or older.I use two reliable birth control methods if I can have children.I have received denosumab in the last year.I have had jawbone infections or conditions needing oral surgery.I have had a bone fracture within the last 3 months.My vitamin D level is below 30 ng/mL.My low phosphorus levels have not been treated properly.I have been diagnosed with Fibrous Dysplasia.I understand the study and can give my consent.I have a dental or oral surgery wound that hasn't healed.I am willing to take calcium and vitamin D supplements.I haven't taken bisphosphonates in the last year.I had bone surgery less than 12 weeks ago.I am willing and able to follow the study's schedule and take the medications as directed.I plan to have a dental surgery during the study.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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