DEnosumab for the treatment of FIbrous Dysplasia/McCune-Albright Syndrome in adults (DeFiD): a randomized double-blind placebo-controlled trial
- Conditions
- Fibrous Dysplasia/McCune Albright syndrome10028396
- Registration Number
- NL-OMON53469
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 82
- Being symptomatic with an 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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The effect of Dmab on pain, assessed by the difference in maximum pain score<br /><br>after 6 months (2 injections) by Brief Pain Inventory</p><br>
- Secondary Outcome Measures
Name Time Method