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New treatment option for Fibrous Dysplasia
Official title DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD)
ClinicalTrials.gov ID: NCT05966064
What this study is testing
What is Denosumab 120 Mg/1.7 Ml Inj?
Denosumab 120 Mg/1.7 Ml Inj is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for fibrous dysplasia.
Also referred to as Xgeva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Fibrous Dysplasia/McCune-Albright syndrome (FD/MAS) is a rare disease, consisting of the replacement of normal bone tissue with fibrous tissue. FD lesions may be isolated in one or more bones or may be associated with endocrinopathies in McCune-Albright syndrome.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Symptomatic patients with established diagnosis of FD/MAS and closed growth plates(\>18 years)
- Pain in the region of an FD localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture
- Pain score from FD lesion for maximum or average pain on VAS ≥ 4
- Increased lesional activity defined as increased bone turnover markers (ALP, P1NP or CTX) or increased activity on Na[18F]-PET/CT or bone...
- Normal levels of calcium, parathyroid hormone and vitamin D (supplementation is allowed)
You likely can't join if
- Active pregnancy wish, pregnancy or nursing
- Pain not related to FD
- Uncontrolled endocrine disease
- Untreated vitamin D deficiency, hypocalcemia or hypophosphatemia
- Previous use of bisphosphonates or Dmab \< 6 months before inclusion ('6 months wash out')
- Previously reported severe side effects on Dmab
See the full eligibility criteria
- Symptomatic patients with established diagnosis of FD/MAS and closed growth plates(\>18 years)
- Pain in the region of an FD localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture
- Pain score from FD lesion for maximum or average pain on VAS ≥ 4
- Increased lesional activity defined as increased bone turnover markers (ALP, P1NP or CTX) or increased activity on Na[18F]-PET/CT or bone scintigraphy in at least one lesion
- Normal levels of calcium, parathyroid hormone and vitamin D (supplementation is allowed)
- Treated hypophosphatemia (defined as \>0.7 at two separate measures)
- good dental health (last check within the last 12 months)
- Active pregnancy wish, pregnancy or nursing
- Pain not related to FD
- Uncontrolled endocrine disease
- Untreated vitamin D deficiency, hypocalcemia or hypophosphatemia
- Previous use of bisphosphonates or Dmab \< 6 months before inclusion ('6 months wash out')
- Previously reported severe side effects on Dmab
- Inability to fulfil study requirements
- Poor untreated dental health without intention to get treatment
- Treatment with other bone influencing drugs, such as high doses corticosteroids
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.