xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966064</url>
    </required_header>
    <id_info>
      <org_study_id>2022-501705-12-00</org_study_id>
      <nct_id>NCT05966064</nct_id>
    </id_info>
    <brief_title>DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD)</brief_title>
    <acronym>DeFiD</acronym>
    <official_title>DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD): a Randomized Double-blind Placebo-controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Natasha Appelman-Dijkstra</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Leiden University Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Fibrous Dysplasia/McCune-Albright syndrome (FD/MAS) is a rare disease, consisting of the&#xD;
        replacement of normal bone tissue with fibrous tissue. FD lesions may be isolated in one or&#xD;
        more bones or may be associated with endocrinopathies in McCune-Albright syndrome. Bone&#xD;
        lesions constitute of weak bone tissue, leading to higher risk of fractures, pain and&#xD;
        decreased quality of life. There is no cure for FD lesions and current therapies failed to&#xD;
        soothe patients' complaints or to display any effect on progression of the lesions on&#xD;
        imaging. However, the RANKL-inhibitor Denosumab demonstrated encouraging results in mouse&#xD;
        models and in off-label clinical use, leading to clinical, biochemical and radiographical&#xD;
        improvements.&#xD;
  &#xD;
        Study's aim is to investigate whether 3-monthly Denosumab will improve the clinical,&#xD;
        radiological and biochemical manifestations of FD bone lesions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Eligible patients will be randomized to treatment with either subcutaneous Dmab 120mg or&#xD;
        placebo at baseline and 3 months in a blinded fashion. At 6 months, after 2 injections,&#xD;
        patients with pain score &lt;4 will exit the study to discontinue study medication and proceed&#xD;
        in usual care, while patients with pain score ≥4 or lesional growth will be offered Dmab 120&#xD;
        mg at 6 and 9 months in an open-label design.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 13, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Denosumab effect on maximal pain score</measure>
      <time_frame>at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>Evaluation of maximal pain score changes after treatment, assessed by Brief Pain Inventory (scale 0 to 10; 0-no pain, 10 worst pain)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on average pain scores</measure>
      <time_frame>at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>Evaluation of average pain score changes after treatment, assessed by Brief Pain Inventory (scale 0 to 10; 0-no pain,10 worst pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the number of patients with 50% reduction of maximal pain (BPI)</measure>
      <time_frame>at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>Evaluation of the number of patients with 50% reduction of maximal pain score changes after treatment, asseses by Brief Pain Inventory (scale 0 to 10; 0-no pain, 10 worst pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on quality of life</measure>
      <time_frame>at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>Evaluation of Denosumab effect on quality of life, assessed with validated questionnaire SF-36 (scale 0-100, higher scores indicate better health status)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on average weekly pain score</measure>
      <time_frame>every week from baseline, through study completion, an average of 1 year</time_frame>
      <description>Evaluation of Denosumab effect on average weekly pain score assessed through a pain diary with VAS score (scale 0 to 10)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on Physical activity assessment assessed through Health Assessment Questionnaire - Disability Index</measure>
      <time_frame>baseline, 3 months and 6 months, and in case of open label treatment after 9 and 12 months</time_frame>
      <description>Evaluation of Denosumab effect on on Physical activity assessment (Health Assessment Questionnaire - Disability Index: Health state index scores generally range from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating higher health utility, though health state preferences can differ between countries.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on Physical activity assessment assessed through screenshot of pedometer</measure>
      <time_frame>baseline, 3 months and 6 months, and in case of open label treatment after 9 and 12 months</time_frame>
      <description>Evaluation of Denosumab effect on on Physical activity assessment ( screenshot of pedometer of activity during the last week on smartphone, unit measure: number of steps during the last week)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of prevalence of possible neuropathic component of the reported pain</measure>
      <time_frame>baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>to evaluate the prevalence of possible neuropathic component of the reported pain through Pain Detect questionnaire (It is scored from 0 to 38, with total scores of less than 12 considered to represent nociceptive pain, 13-18 possible NeP, and &gt;19 representing &gt;90% likelihood of Neuropathic pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To investigate the number of analgesics used for pain</measure>
      <time_frame>baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>number of used analgesics for pain : unit of measure: number</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To investigate the frequency use of analgesics for pain</measure>
      <time_frame>baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>the frequency use of analgesics for pain (daily, multiple times per day, multiple times per week, monthly, when necessary)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To investigate the dosage of analgesics used for pain</measure>
      <time_frame>baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>dosage of analgesics used for pain (unit of measure: mg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on serum bone markers</measure>
      <time_frame>baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>effect of denosumab on bone serum markers (alkaline phosphatase (measure unit: U/L), P1NP -Procollagen-1-propeptide (measure unit: ng/ml), Beta-crosslaps (measure unit: ug/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on serum markers</measure>
      <time_frame>baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months</time_frame>
      <description>effect of Denosumab on serum calcium(mmol/L), fosfate (mmol/L), PTH (pmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on lesion size</measure>
      <time_frame>baseline and after 6 months, and in the case of open label treatment after 12 months</time_frame>
      <description>Na18F-PET/CT scan- measurement of lesion size</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on lesion activity</measure>
      <time_frame>baseline and after 6 months, and in the case of open label treatment after 12 months</time_frame>
      <description>Na18F-PET/CT scan- ,measurement of Na18F uptake</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>disease quantification (Skeletal Burden Score (SBS)</measure>
      <time_frame>at baseline, 6 months and after 12 months</time_frame>
      <description>nuclear imaging ((Skeletal Burden Score (SBS): scale 0 to 75, higher scores meaning increased disease activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on bone density</measure>
      <time_frame>baseline and after 12 months</time_frame>
      <description>Dual-energy X-ray absorptiometry (DXA) - bone density measurement ( T-score of -1.0 or above = normal bone density T-score between -1.0 and -2.5 = low bone density, or osteopenia; T-score of -2.5 or lower = osteoporosis)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Denosumab effect on vertebral fractures</measure>
      <time_frame>baseline and after 12 months</time_frame>
      <description>Dual-energy X-ray absorptiometry (DXA) - assement of presence of Vertebral Fractures through Vertebral Fractures Assessment (VFA) and changes from baseline until 12 months after</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess potential side effects in the form of Atypical femoral fractures</measure>
      <time_frame>after 12 months</time_frame>
      <description>Dual-energy X-ray absorptiometry (DXA) femur extended</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Fibrous Dysplasia</condition>
    <condition>McCune Albright Syndrome</condition>
    <arm_group>
      <arm_group_label>Denosumab</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Denosumab randomized at baseline and 3 months in a double-blinded fashion and in case of open label at 6 and 9 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo randomized at baseline and 3 months in a double-blinded fashion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Denosumab 120 Mg/1.7 Ml Inj</intervention_name>
      <description>Denosumab randomized at baseline and after 3 months at 6 and 9 months in case of open label</description>
      <arm_group_label>Denosumab</arm_group_label>
      <other_name>Xgeva</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>placebo randomized at baseline and after 3 months</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Symptomatic patients with established diagnosis of FD/MAS and closed growth plates(&gt;18&#xD;
               years)&#xD;
  &#xD;
            -  Pain in the region of an FD localization, not responding to adequate pain treatment&#xD;
               and without mechanical component e.g. impending fracture&#xD;
  &#xD;
            -  Pain score from FD lesion for maximum or average pain on VAS ≥ 4&#xD;
  &#xD;
            -  Increased lesional activity defined as increased bone turnover markers (ALP, P1NP or&#xD;
               CTX) or increased activity on Na[18F]-PET/CT or bone scintigraphy in at least one&#xD;
               lesion&#xD;
  &#xD;
            -  Normal levels of calcium, parathyroid hormone and vitamin D (supplementation is&#xD;
               allowed)&#xD;
  &#xD;
            -  Treated hypophosphatemia (defined as &gt;0.7 at two separate measures)&#xD;
  &#xD;
            -  good dental health (last check within the last 12 months)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active pregnancy wish, pregnancy or nursing&#xD;
  &#xD;
            -  Pain not related to FD&#xD;
  &#xD;
            -  Uncontrolled endocrine disease&#xD;
  &#xD;
            -  Untreated vitamin D deficiency, hypocalcemia or hypophosphatemia&#xD;
  &#xD;
            -  Previous use of bisphosphonates or Dmab &lt; 6 months before inclusion ('6 months wash&#xD;
               out')&#xD;
  &#xD;
            -  Previously reported severe side effects on Dmab&#xD;
  &#xD;
            -  Inability to fulfil study requirements&#xD;
  &#xD;
            -  Poor untreated dental health without intention to get treatment&#xD;
  &#xD;
            -  Treatment with other bone influencing drugs, such as high doses corticosteroids&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Natasha Appelman-Dijsktra, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Leiden University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Natasha Appelman-Dijkstra, MD, PhD</last_name>
      <phone>+31 625301410</phone>
      <email>n.m.appelman-dijkstra@lumc.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Leiden University Medical Center</name>
        <address>
          <city>Leiden</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Natasha Appelman-Dijkstra, MD, PhD</last_name>
        <phone>+31 625301410</phone>
        <email>n.m.appelman-dijkstra@lumc.nl</email>
      </contact>
      <investigator>
        <last_name>Natasha Appelman-Dijkstra</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
      <investigator_full_name>Natasha Appelman-Dijkstra</investigator_full_name>
      <investigator_title>Principal investigator, Internist-Endocrinologist, MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibrous Dysplasia of Bone</mesh_term>
      <mesh_term>Fibrous Dysplasia, Polyostotic</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Denosumab</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966064
  org study id: 2022-501705-12-00
  nct id: NCT05966064
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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. Bone
        lesions constitute of weak bone tissue, leading to higher risk of fractures, pain and
        decreased quality of life. There is no cure for FD lesions and current therapies failed to
        soothe patients' complaints or to display any effect on progression of the lesions on
        imaging. However, the RANKL-inhibitor Denosumab demonstrated encouraging results in mouse
        models and in off-label clinical use, leading to clinical, biochemical and radiographical
        improvements.
  
        Study's aim is to investigate whether 3-monthly Denosumab will improve the clinical,
        radiological and biochemical manifestations of FD bone lesions.
  Eligible patients will be randomized to treatment with either subcutaneous Dmab 120mg or
        placebo at baseline and 3 months in a blinded fashion. At 6 months, after 2 injections,
        patients with pain score <4 will exit the study to discontinue study medication and proceed
        in usual care, while patients with pain score ≥4 or lesional growth will be offered Dmab 120
        mg at 6 and 9 months in an open-label design.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Denosumab effect on maximal pain score
  time frame: at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months
  description: Evaluation of maximal pain score changes after treatment, assessed by Brief Pain Inventory (scale 0 to 10; 0-no pain, 10 worst pain)
  measure: Denosumab effect on average pain scores
  time frame: at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months
  description: Evaluation of average pain score changes after treatment, assessed by Brief Pain Inventory (scale 0 to 10; 0-no pain,10 worst pain)
  measure: To evaluate the number of patients with 50% reduction of maximal pain (BPI)
  time frame: at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months
  description: Evaluation of the number of patients with 50% reduction of maximal pain score changes after treatment, asseses by Brief Pain Inventory (scale 0 to 10; 0-no pain, 10 worst pain)
  measure: Denosumab effect on quality of life
  time frame: at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months
  description: Evaluation of Denosumab effect on quality of life, assessed with validated questionnaire SF-36 (scale 0-100, higher scores indicate better health status)
  measure: Denosumab effect on average weekly pain score
  time frame: every week from baseline, through study completion, an average of 1 year
  description: Evaluation of Denosumab effect on average weekly pain score assessed through a pain diary with VAS score (scale 0 to 10)
  measure: Denosumab effect on Physical activity assessment assessed through Health Assessment Questionnaire - Disability Index
  time frame: baseline, 3 months and 6 months, and in case of open label treatment after 9 and 12 months
  description: Evaluation of Denosumab effect on on Physical activity assessment (Health Assessment Questionnaire - Disability Index: Health state index scores generally range from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating higher health utility, though health state preferences can differ between countries.
  measure: Denosumab effect on Physical activity assessment assessed through screenshot of pedometer
  time frame: baseline, 3 months and 6 months, and in case of open label treatment after 9 and 12 months
  description: Evaluation of Denosumab effect on on Physical activity assessment ( screenshot of pedometer of activity during the last week on smartphone, unit measure: number of steps during the last week)
  measure: Evaluation of prevalence of possible neuropathic component of the reported pain
  time frame: baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
  description: to evaluate the prevalence of possible neuropathic component of the reported pain through Pain Detect questionnaire (It is scored from 0 to 38, with total scores of less than 12 considered to represent nociceptive pain, 13-18 possible NeP, and >19 representing >90% likelihood of Neuropathic pain)
  measure: To investigate the number of analgesics used for pain
  time frame: baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
  description: number of used analgesics for pain : unit of measure: number
  measure: To investigate the frequency use of analgesics for pain
  time frame: baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
  description: the frequency use of analgesics for pain (daily, multiple times per day, multiple times per week, monthly, when necessary)
  measure: To investigate the dosage of analgesics used for pain
  time frame: baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
  description: dosage of analgesics used for pain (unit of measure: mg)
  measure: Denosumab effect on serum bone markers
  time frame: baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
  description: effect of denosumab on bone serum markers (alkaline phosphatase (measure unit: U/L), P1NP -Procollagen-1-propeptide (measure unit: ng/ml), Beta-crosslaps (measure unit: ug/L)
  measure: Denosumab effect on serum markers
  time frame: baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
  description: effect of Denosumab on serum calcium(mmol/L), fosfate (mmol/L), PTH (pmol/L)
  measure: Denosumab effect on lesion size
  time frame: baseline and after 6 months, and in the case of open label treatment after 12 months
  description: Na18F-PET/CT scan- measurement of lesion size
  measure: Denosumab effect on lesion activity
  time frame: baseline and after 6 months, and in the case of open label treatment after 12 months
  description: Na18F-PET/CT scan- ,measurement of Na18F uptake
  measure: disease quantification (Skeletal Burden Score (SBS)
  time frame: at baseline, 6 months and after 12 months
  description: nuclear imaging ((Skeletal Burden Score (SBS): scale 0 to 75, higher scores meaning increased disease activity
  measure: Denosumab effect on bone density
  time frame: baseline and after 12 months
  description: Dual-energy X-ray absorptiometry (DXA) - bone density measurement ( T-score of -1.0 or above = normal bone density T-score between -1.0 and -2.5 = low bone density, or osteopenia; T-score of -2.5 or lower = osteoporosis)
  measure: Denosumab effect on vertebral fractures
  time frame: baseline and after 12 months
  description: Dual-energy X-ray absorptiometry (DXA) - assement of presence of Vertebral Fractures through Vertebral Fractures Assessment (VFA) and changes from baseline until 12 months after
  measure: To assess potential side effects in the form of Atypical femoral fractures
  time frame: after 12 months
  description: Dual-energy X-ray absorptiometry (DXA) femur extended
  arm group label: Denosumab
  arm group type: Active Comparator
  description: Denosumab randomized at baseline and 3 months in a double-blinded fashion and in case of open label at 6 and 9 months
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo randomized at baseline and 3 months in a double-blinded fashion.
  intervention type: Drug
  intervention name: Denosumab 120 Mg/1.7 Ml Inj
  description: Denosumab randomized at baseline and after 3 months at 6 and 9 months in case of open label
  arm group label: Denosumab
  other name: Xgeva
  intervention type: Drug
  intervention name: Placebo
  description: placebo randomized at baseline and after 3 months
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Natasha Appelman-Dijsktra, MD, PhD
  role: Principal Investigator
  affiliation: Leiden University Medical Center
  last name: Natasha Appelman-Dijkstra, MD, PhD
  phone: +31 625301410
  email: n.m.appelman-dijkstra@lumc.nl
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Netherlands
  responsible party type: Sponsor-Investigator
  investigator affiliation: Leiden University Medical Center
  investigator full name: Natasha Appelman-Dijkstra
  investigator title: Principal investigator, Internist-Endocrinologist, MD, PhD
  mesh term: Fibrous Dysplasia of Bone
  mesh term: Fibrous Dysplasia, Polyostotic
  mesh term: Syndrome
  mesh term: Denosumab