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DEnosumab for the treatment of FIbrous Dysplasia/McCune-Albright Syndrome in adults (DeFiD): a randomized double-blind placebo-controlled trial
EU CTIS ID: 2024-511090-30-00
What this study is testing
To evaluate the effect of Denosumab on pain, assessed by the difference in maximum pain scores after 6 months (2 injections)
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Being symptomatic with an established diagnosis of FD/MAS and closed growth plates (>18 years)
- Pain in the region of an Fibrous dysplasia localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture
- Pain score from Fibrous dysplasia 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 Na18F-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)
You likely can't join if
- Active pregnancy wish, pregnancy or nursing
- Pain not related to Fibrous dysplasia
- 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 Denosumab
See the full eligibility criteria
- Being symptomatic with an established diagnosis of FD/MAS and closed growth plates (>18 years)
- Pain in the region of an Fibrous dysplasia localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture
- Pain score from Fibrous dysplasia 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 Na18F-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 Fibrous dysplasia
- 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 Denosumab
- 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.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.