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| ID | Type | Description | Link |
|---|---|---|---|
| 000798-D |
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Background:
Fibrous dysplasia (FD) is a disorder that affects bone growth. Affected bone tissue is weakened, and people with FD are prone to deformities, fractures, and other problems. People with FD may also have low blood phosphate levels. This can make bones even weaker. Better treatments are needed.
Objective:
To test a study drug (burosumab) in people with FD who have low blood phosphate levels.
Eligibility:
People aged 1 year or older who have FD and low blood phosphate levels.
Design:
Participants will visit the NIH 3 times in 48 weeks. Each visit will last 5 to 7 days.
Participants will self-inject burosumab under the skin in their belly, upper arm, or thigh. They (or a caregiver) will do this at home 1 or 2 times a month. They will be trained in person on how to inject the drug. Home injections will be guided via telehealth.
During NIH visits, participants will have a physical exam with blood and urine tests. They will have x-rays of different parts of their body. They will have a radioactive tracer injected into their vein; then they will have a bone scan. They will have tests to assess their strength, walking, and movement. They will complete questionnaires about their pain, mobility, and fatigue levels.
Adult participants may have bone biopsies. These will be done under anesthesia with sedation. Small samples of FD-affected bone will be removed for study.
Between NIH visits, participants will go to a local laboratory for blood and urine tests.
Child participants will have an additional follow-up visit 2 weeks after the final NIH visit.
Study Description:
This will be a phase 2, open-label, single-arm study to evaluate the safety and efficacy of burosumab to normalize serum phosphate levels in subjects with fibrous dysplasia (FD) and fibroblast growth factor 23 (FGF23)-mediated hypophosphatemia.
Objectives:
Primary Objective:
-Evaluate the efficacy of burosumab to normalize serum phosphate levels in subjects with FD and FGF23-mediated hypophosphatemia at 48 weeks.
Secondary Objectives:
Endpoints:
Primary Endpoint:
-The proportion of subjects achieving serum phosphate levels within the target range (Z-score -1 to +2) at Week 48.
Secondary Endpoints:
Proportion of subjects achieving serum phosphate levels within the target range (Z-score -1 to +2) at Week 24.
Adverse events and clinical safety laboratory tests for up to 4 weeks after the final burosumab dose (48 weeks for adult subjects, 50 weeks for pediatric subjects).
Change and percent change from baseline to post-baseline visits in serum phosphate, serum 1,25(OH)2D, ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR).
Change in FD lesion activity using Fluorine-18 Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NaF PET/CT) total lesion activity from baseline to 48 weeks
Change and percent change in serum bone turnover markers, including procollagen 1 N-terminal propeptide (P1NP), beta crosslaps C-telopeptides (CTX), osteocalcin, and bone-specific alkaline phosphatase from baseline to 48 weeks.
Change in FD lesion histology and cell proliferation as assessed by minimally invasive bone biopsies from baseline to 48 weeks (adults with capacity to consent only) from baseline to 48 weeks
Skeletal changes assessed on skeletal survey at baseline and 48 weeks
Change from baseline to 48 weeks in:
Change from baseline to 48 weeks in patient reported outcomes measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with burosumab | Experimental | Participants with Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) and hypophosphatemia receive burosumab subcutaneously dosed to the nearest 10mg. Pediatric participants receive 0.8mg/kg subcutaneously every two weeks for 48 weeks. Adult participants receive 0.5mg/kg subcutaneously every four weeks, with the option to receive dose every two weeks, for 48 weeks. All participants receive a minimum dose of 10mg/dose and a maximum of 90mg/dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burosumab | Drug | Human recombinant monoclonal antibody to fibroblast growth factor-23 (FGF23) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 48 | The proportion of participants who achieved serum phosphate levels within the target range (Z-score -1 to +2) at week 48. Analysis was done by dividing the number of number of participants who achieved serum level by the number of participants analyzed. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Adverse Event by Grade | Number participants with any adverse events by grade, up to 4 weeks after the final burosumab dose, was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
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In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Confirmed diagnosis of fibrous dysplasia
Serum phosphate <10th percentile for age and sex, AND intact serum FGF23 >=30 pg/mL
Age >=1 year
Provision of signed and dated informed consent/assent form
Stated willingness of subject or Legally Authorized Representative (LAR) to comply with all study procedures and availability for the duration of the study
For females of reproductive potential: agreement to use highly effective contraception for during study participation. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment.
Male sterilization (at least 6 months prior to screening). For female participants on the study the vasectomized male partner should be the sole partner for that participant.
Combination of the following (a+b or a+c, or b+c):
For males of reproductive potential: use of condoms or other methods described above to ensure effective contraception with partner
Minimum body weight of 7.5 kilograms
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Alison M Boyce, M.D. | National Institute of Dental and Craniofacial Research (NIDCR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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This study will comply with the NIH Data Sharing Policy and the Clinical Trials Registration and Results Information Submission rule.
Results from this trial will be made available 12 months after the primary study completion date
Investigators from NIH and Ultragenyx and Kyowa Kirin will consider requests from qualified researchers for access to clinical data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Burosumab | Participants with Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) and hypophosphatemia receive burosumab subcutaneously dosed to the nearest 10mg. Pediatric participants receive 0.8mg/kg subcutaneously every two weeks for 48 weeks. Adult participants receive 0.5mg/kg subcutaneously every four weeks, with the option to receive dose every two weeks, for 48 weeks. All participants receive a minimum dose of 10mg/dose and a maximum of 90mg/dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Burosumab | Participants treated with burosumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 48 | The proportion of participants who achieved serum phosphate levels within the target range (Z-score -1 to +2) at week 48. Analysis was done by dividing the number of number of participants who achieved serum level by the number of participants analyzed. | Modified intent to treat population | Posted | Number | Proportion of participant | Week 48 |
|
48 weeks for adult participants; 50 weeks for pediatric participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Burosumab | Participants with Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) and hypophosphatemia receive burosumab subcutaneously dosed to the nearest 10mg. Pediatric participants receive 0.8mg/kg subcutaneously every two weeks for 48 weeks. Adult participants receive 0.5mg/kg subcutaneously every four weeks, with the option to receive dose every two weeks, for 48 weeks. All participants receive a minimum dose of 10mg/dose and a maximum of 90mg/dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Boyce | National Institute of Dental and Craniofacial Research | +1 301 827 4802 | alison.boyce@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2024 | Nov 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005357 | Fibrous Dysplasia of Bone |
| D005359 | Fibrous Dysplasia, Polyostotic |
| D012279 | Rickets |
| D010018 | Osteomalacia |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000601956 | burosumab |
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| 48 weeks for adult participants; 50 weeks for pediatric participants |
| Participants With Related Adverse Event | Participants with related adverse events up to 4 weeks after the final burosumab dose (48 weeks for adult subjects, 50 weeks for pediatric subjects). Adverse event was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Related adverse event means that there are available evidence that suggests that there is a reasonable possibility that the study drug caused the adverse event. | 48 weeks for adult participants; 50 weeks for pediatric participants |
| Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 24 | The proportion of participants who achieved serum phosphate levels within the target range (Z-score -1 to +2) at week 24. Analysis was done by dividing the number of number of participants who achieved serum level by the number of participants analyzed. | Week 24 |
| Proportion of Participants With Serum Phosphate Levels Above the Target Range (Z-score >+2) | The proportion of participants who achieved serum phosphate levels above the target range (Z-score >+2) at any timepoint between baseline and week 48. Analysis was done by dividing the number of number of participants who achieved serum level above the target range by the number of participants analyzed. | Between baseline and week 48 |
| Change in Serum Phosphate Level | Change in serum phosphate level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Percent Change in Serum Phosphate Level | Percent change in serum phosphate level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Serum 1,25-dihydroxyvitamin D Level | Change in serum 1,25-dihydroxyvitamin D level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Percent Change in Serum 1,25-dihydroxyvitamin D Level | Percent change in serum 1,25-dihydroxyvitamin D level from baseline to 48 weeks. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = 48 weeks minus baseline. | Week 48 minus baseline |
| Change in Serum Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR) | Change in serum ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Percent Change in Serum Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR) | Percent change in serum ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Fibrous Dysplasia Lesion Activity Using Fluorine-18 Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NaF PET/CT) Scan | Change in fibrous dysplasia lesion activity using Fluorine-18 Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NaF PET/CT) scan from baseline to week 48. 18F-NaF PET/CT scan was done at baseline and week 48 and total lesion activity units were calculated from each scan. Change in lesion activity was compared between timepoints, baseline and week 48. Change = 48 weeks minus baseline. | Week 48 minus baseline |
| Change in Serum Procollagen 1 N-terminal Propeptide (P1NP) Level | Change in serum procollagen 1 N-terminal propeptide (P1NP) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Percent Change in Serum Procollagen 1 N-terminal Propeptide (P1NP) Level | Percent change in serum procollagen 1 N-terminal propeptide (P1NP) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Serum Beta Crosslaps C-telopeptides (CTX) Level | Change in serum beta crosslaps C-telopeptides (CTX) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Percent Change in Serum Beta Crosslaps C-telopeptides (CTX) Level | Percent change in serum beta crosslaps C-telopeptides (CTX) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Serum Osteocalcin Level | Change in serum osteocalcin level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Percent Change in Serum Osteocalcin Level | Percent change in serum osteocalcin level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Serum Alkaline Phosphatase Level | Change in serum alkaline phosphatase level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Percent Change in Serum Alkaline Phosphatase Level | Percent change in serum alkaline phosphatase level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Fibrous Dysplasia Lesion Cellularity | Change in fibrous dysplasia lesion cellularity was assessed by minimally invasive bone biopsies at baseline and week 48 in only adult participants with capacity to consent to procedure. Bone biopsies assessed the count of cell density. Analysis was done as change in median cell density value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Muscle Strength Using the Manual Muscle Test Scale | Muscle strength was assessed using the manual muscle test (MMT) scale. MMT is a clinical technique to assess the strength of individual muscles or muscle groups based on ability to move against gravity and resist applied external pressure on a 0-5 scale, with 0 (no contraction), 1 (trace), 2 (poor) (movement with gravity eliminated), 3 (fair) (movement against gravity), 4 (good) (movement against gravity with moderate resistance), and 5 (normal strength). Higher number indicates better muscle resistance and strength. Each muscle group was assessed at baseline and week 48. Analysis was done for each muscle as change between baseline and week 48 (week 48 - baseline). | Week 48 minus baseline |
| Change in Muscle Range-of-motion | Muscle range-of-motion was measured as the degree of movement of muscles. Assessment was done at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Walking Speed Measured by the 9-minute Walk Test (9MWT) | Change in walking speed was measured by the 9-minute walk test from baseline to week 48. The 9-minute walk test (9MWT) is a measure of physical capacity and participants are instructed to run or walk over a time period of nine minutes. The 9-minute walk test distance (9MWD) is the total distance walked in meters during the 9MWT and greater distance walked means better physical capacity. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score | The change in quality of life for the adult participants was assessed using the Short Form Health Survey (SF-36). SF-36 is a 36-item patient-reported survey of patient health status that consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The higher the score, the less disability. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Health-related Quality of Life Measured by the 10-Item Short Form Health Survey (SF-10) - Physical Summary Score (PHS) | The change in quality of life for the pediatric participants was assessed using the Short-Form Health Survey-10 (SF-10). The Short-Form Health Survey (SF-10) is a 10-item parent-completed questionnaire that covers a wide range of domains affecting a child's functional health and well-being. The SF-10 is scored to produce two norm-based summary scores: a Physical Summary Score (PHS) and a Psychosocial Summary Score (PSS), each with a mean of 50 and a standard deviation of 10. Analysis was based on the PHS. The PHS scale is directly transformed into a 0-100 scale. The higher the score, the less disability. Measurements were taken for the Physical Summary Score (PHS) at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 1.0) - Pain Intensity Domain | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Pediatric and Parent Proxy version 1.0) domain measures pain intensity in children, with pediatric self-report versions for ages 8-17 and parent proxy-report versions for children aged 5-17. This measure uses a standard scale to assess the level of pain over the past seven days, and for the current moment, providing a quantitative score that reflects the severity of the pain. The scale consist of three items with each scored on a 5-point Likert scale, 1-5 with lowest score of 3 and highest of 15. The raw score is converted to a T-score with a mean of 50 and standard deviation of 10. Higher scores indicates greater pain intensity. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Adult Version 2.0) - Pain Intensity Domain | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Adult version 2.0) - Pain Intensity domain is a universal, self-report measure of how much pain a person is experiencing. This measure uses a standard scale to assess the level of pain over the past seven days, and for the current moment, providing a quantitative score that reflects the severity of the pain. The scale consist of three items with each scored on a 5-point Likert scale, 1-5 with lowest score of 3 and highest of 15. The raw score is converted to a T-score with a mean of 50 and standard deviation of 10. Higher scores indicates greater pain intensity. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 2.0) - Pain Inference Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Pediatric and Parent Proxy version 2.0) - Pain Inference Domain assesses how pain impacts daily life, sleep, and enjoyment in children, with the Pediatric version being self-reported by children aged 8-17 and the Parent Proxy version completed by a parent or guardian for their child aged 5-17. This measure uses a standard scale to assess the level of pain interference over the past seven days, and for the current moment, providing a quantitative score that reflects the severity of the pain interference. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater pain interference. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Adult Version 1.1) - Pain Inference Domain | The Patient-Reported Outcomes Measurement Information System (PROMIS) (Adult version 1.1) - Pain Inference scale assesses the impact of pain on social, physical, cognitive, emotional, and recreational activities, as well as sleep and life enjoyment. The scale consists of 12 items and each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater pain interference. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 2.0) - Mobility Lower Extremity Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Pediatric and Parent Proxy version 2.0) Mobility Lower Extremity domain assesses self-perceived mobility in children, with the Pediatric version being self-reported by children aged 8-17 and the Parent Proxy version completed by a parent or guardian for their child aged 5-17. This measure uses a standard scale to assess lower extremity mobility by asking about activities such as getting up from a chair or running over the past seven days. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater mobility. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Adult Version 2.0) - Mobility Lower Extremity Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Adult version 2.0) Mobility Lower Extremity Domain assesses an adult's self-perceived ability to perform physical tasks related to mobility and lower extremity function, such as getting out of a chair or walking. This measure uses a standard scale to assess lower extremity mobility by asking about mobility activities over the past seven days. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater mobility. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 minus baseline |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 2.0) - Fatigue Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Pediatric and Parent Proxy version 2.0) Fatigue domain assess the level and impact of fatigue in children and adolescents, with the Pediatric version being self-reported by children aged 8-17 and the Parent Proxy version completed by a parent or guardian for their child aged 5-17. This measure uses a standard scale to assess the level of fatigue over the past seven days. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10 based on a US general population. Higher scores indicate worsening fatigue. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) - Short Form - Fatigue 13a (Adult FACIT 13a v1.0) | The Patient Reported Outcome Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale is a 13-item patient-reported outcome (PRO) questionnaire that captures the individual's subjective experience of their fatigue. The fatigue domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates less fatigue. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Week 48 |
| Proportion of Participants With Change in Activities of Daily Living (ADL) Questions | Proportion of participants with change in activities of daily living (ADL) questions from baseline to week 48 was assessed using a study developed questionnaire. Participants and/or caregivers were asked to provide a list of three activities of daily living that were affected by fibrous dysplasia skeletal features at home or school/work (e.g., mobility, climbing stairs, dressing, playing with peers, catching a bus, etc.) and to rate the extent of impact upon their activity level using one of the option:
These activities were assessed at baseline, then reassessed at Week 24 and Week 48. Analysis was done as proportion of participants reporting "much improved" or "very much improved" in Activities of Daily Living Questions. Change = Week 48 minus baseline. | Week 48 minus baseline |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Secondary | Participants With Adverse Event by Grade | Number participants with any adverse events by grade, up to 4 weeks after the final burosumab dose, was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Modified intent to treat population | Posted | Count of Participants | Participants | 48 weeks for adult participants; 50 weeks for pediatric participants |
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| Secondary | Participants With Related Adverse Event | Participants with related adverse events up to 4 weeks after the final burosumab dose (48 weeks for adult subjects, 50 weeks for pediatric subjects). Adverse event was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Related adverse event means that there are available evidence that suggests that there is a reasonable possibility that the study drug caused the adverse event. | Modified intent to treat population | Posted | Count of Participants | Participants | 48 weeks for adult participants; 50 weeks for pediatric participants |
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| Secondary | Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 24 | The proportion of participants who achieved serum phosphate levels within the target range (Z-score -1 to +2) at week 24. Analysis was done by dividing the number of number of participants who achieved serum level by the number of participants analyzed. | Modified intent to treat population | Posted | Number | Proportion of participants | Week 24 |
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| Secondary | Proportion of Participants With Serum Phosphate Levels Above the Target Range (Z-score >+2) | The proportion of participants who achieved serum phosphate levels above the target range (Z-score >+2) at any timepoint between baseline and week 48. Analysis was done by dividing the number of number of participants who achieved serum level above the target range by the number of participants analyzed. | Modified intent to treat population | Posted | Number | Proportion of participants | Between baseline and week 48 |
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| Secondary | Change in Serum Phosphate Level | Change in serum phosphate level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | mg/dL | Week 48 minus baseline |
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| Secondary | Percent Change in Serum Phosphate Level | Percent change in serum phosphate level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Percentage of change | Week 48 minus baseline |
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| Secondary | Change in Serum 1,25-dihydroxyvitamin D Level | Change in serum 1,25-dihydroxyvitamin D level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | ng/mL | Week 48 minus baseline |
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| Secondary | Percent Change in Serum 1,25-dihydroxyvitamin D Level | Percent change in serum 1,25-dihydroxyvitamin D level from baseline to 48 weeks. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = 48 weeks minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Percentage of change | Week 48 minus baseline |
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|
| Secondary | Change in Serum Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR) | Change in serum ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | mmol/L | Week 48 minus baseline |
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|
|
| Secondary | Percent Change in Serum Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR) | Percent change in serum ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Percentage of change | Week 48 minus baseline |
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|
|
| Secondary | Change in Fibrous Dysplasia Lesion Activity Using Fluorine-18 Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NaF PET/CT) Scan | Change in fibrous dysplasia lesion activity using Fluorine-18 Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NaF PET/CT) scan from baseline to week 48. 18F-NaF PET/CT scan was done at baseline and week 48 and total lesion activity units were calculated from each scan. Change in lesion activity was compared between timepoints, baseline and week 48. Change = 48 weeks minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Total lesion activity units | Week 48 minus baseline |
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|
|
| Secondary | Change in Serum Procollagen 1 N-terminal Propeptide (P1NP) Level | Change in serum procollagen 1 N-terminal propeptide (P1NP) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | mcg/L | Week 48 minus baseline |
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|
|
| Secondary | Percent Change in Serum Procollagen 1 N-terminal Propeptide (P1NP) Level | Percent change in serum procollagen 1 N-terminal propeptide (P1NP) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Percentage of change | Week 48 minus baseline |
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|
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| Secondary | Change in Serum Beta Crosslaps C-telopeptides (CTX) Level | Change in serum beta crosslaps C-telopeptides (CTX) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | pg/mL | Week 48 minus baseline |
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|
|
| Secondary | Percent Change in Serum Beta Crosslaps C-telopeptides (CTX) Level | Percent change in serum beta crosslaps C-telopeptides (CTX) level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Percentage of change | Week 48 minus baseline |
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| Secondary | Change in Serum Osteocalcin Level | Change in serum osteocalcin level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | ng/mL | Week 48 minus baseline |
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|
|
| Secondary | Percent Change in Serum Osteocalcin Level | Percent change in serum osteocalcin level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Percentage of change | Week 48 minus baseline |
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| Secondary | Change in Serum Alkaline Phosphatase Level | Change in serum alkaline phosphatase level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | U/L | Week 48 minus baseline |
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|
|
| Secondary | Percent Change in Serum Alkaline Phosphatase Level | Percent change in serum alkaline phosphatase level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Percentage of change | Week 48 minus baseline |
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|
| Secondary | Change in Fibrous Dysplasia Lesion Cellularity | Change in fibrous dysplasia lesion cellularity was assessed by minimally invasive bone biopsies at baseline and week 48 in only adult participants with capacity to consent to procedure. Bone biopsies assessed the count of cell density. Analysis was done as change in median cell density value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Fibrosis nuclei/mcm^2 | Week 48 minus baseline |
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| Secondary | Change in Muscle Strength Using the Manual Muscle Test Scale | Muscle strength was assessed using the manual muscle test (MMT) scale. MMT is a clinical technique to assess the strength of individual muscles or muscle groups based on ability to move against gravity and resist applied external pressure on a 0-5 scale, with 0 (no contraction), 1 (trace), 2 (poor) (movement with gravity eliminated), 3 (fair) (movement against gravity), 4 (good) (movement against gravity with moderate resistance), and 5 (normal strength). Higher number indicates better muscle resistance and strength. Each muscle group was assessed at baseline and week 48. Analysis was done for each muscle as change between baseline and week 48 (week 48 - baseline). | Modified intent to treat population; participants were excluded from the specific muscle strength analysis if unable to complete the individual muscle strength test. | Posted | Median | Full Range | Units on a scale | Week 48 minus baseline |
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| Secondary | Change in Muscle Range-of-motion | Muscle range-of-motion was measured as the degree of movement of muscles. Assessment was done at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population; participants were excluded from the specific muscle strength analysis if unable to complete the individual muscle strength test. | Posted | Median | Full Range | Degrees | Week 48 minus baseline |
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| Secondary | Change in Walking Speed Measured by the 9-minute Walk Test (9MWT) | Change in walking speed was measured by the 9-minute walk test from baseline to week 48. The 9-minute walk test (9MWT) is a measure of physical capacity and participants are instructed to run or walk over a time period of nine minutes. The 9-minute walk test distance (9MWD) is the total distance walked in meters during the 9MWT and greater distance walked means better physical capacity. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population; analysis excludes non-ambulatory participants. | Posted | Median | Full Range | Meters | Week 48 minus baseline |
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| Secondary | Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score | The change in quality of life for the adult participants was assessed using the Short Form Health Survey (SF-36). SF-36 is a 36-item patient-reported survey of patient health status that consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The higher the score, the less disability. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Units on a scale | Week 48 minus baseline |
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| Secondary | Change in Health-related Quality of Life Measured by the 10-Item Short Form Health Survey (SF-10) - Physical Summary Score (PHS) | The change in quality of life for the pediatric participants was assessed using the Short-Form Health Survey-10 (SF-10). The Short-Form Health Survey (SF-10) is a 10-item parent-completed questionnaire that covers a wide range of domains affecting a child's functional health and well-being. The SF-10 is scored to produce two norm-based summary scores: a Physical Summary Score (PHS) and a Psychosocial Summary Score (PSS), each with a mean of 50 and a standard deviation of 10. Analysis was based on the PHS. The PHS scale is directly transformed into a 0-100 scale. The higher the score, the less disability. Measurements were taken for the Physical Summary Score (PHS) at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | Units on a scale | Week 48 minus baseline |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 1.0) - Pain Intensity Domain | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Pediatric and Parent Proxy version 1.0) domain measures pain intensity in children, with pediatric self-report versions for ages 8-17 and parent proxy-report versions for children aged 5-17. This measure uses a standard scale to assess the level of pain over the past seven days, and for the current moment, providing a quantitative score that reflects the severity of the pain. The scale consist of three items with each scored on a 5-point Likert scale, 1-5 with lowest score of 3 and highest of 15. The raw score is converted to a T-score with a mean of 50 and standard deviation of 10. Higher scores indicates greater pain intensity. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 minus baseline |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Adult Version 2.0) - Pain Intensity Domain | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Adult version 2.0) - Pain Intensity domain is a universal, self-report measure of how much pain a person is experiencing. This measure uses a standard scale to assess the level of pain over the past seven days, and for the current moment, providing a quantitative score that reflects the severity of the pain. The scale consist of three items with each scored on a 5-point Likert scale, 1-5 with lowest score of 3 and highest of 15. The raw score is converted to a T-score with a mean of 50 and standard deviation of 10. Higher scores indicates greater pain intensity. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 minus baseline |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 2.0) - Pain Inference Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Pediatric and Parent Proxy version 2.0) - Pain Inference Domain assesses how pain impacts daily life, sleep, and enjoyment in children, with the Pediatric version being self-reported by children aged 8-17 and the Parent Proxy version completed by a parent or guardian for their child aged 5-17. This measure uses a standard scale to assess the level of pain interference over the past seven days, and for the current moment, providing a quantitative score that reflects the severity of the pain interference. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater pain interference. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 minus baseline |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Adult Version 1.1) - Pain Inference Domain | The Patient-Reported Outcomes Measurement Information System (PROMIS) (Adult version 1.1) - Pain Inference scale assesses the impact of pain on social, physical, cognitive, emotional, and recreational activities, as well as sleep and life enjoyment. The scale consists of 12 items and each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater pain interference. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 minus baseline |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 2.0) - Mobility Lower Extremity Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Pediatric and Parent Proxy version 2.0) Mobility Lower Extremity domain assesses self-perceived mobility in children, with the Pediatric version being self-reported by children aged 8-17 and the Parent Proxy version completed by a parent or guardian for their child aged 5-17. This measure uses a standard scale to assess lower extremity mobility by asking about activities such as getting up from a chair or running over the past seven days. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater mobility. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 minus baseline |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Adult Version 2.0) - Mobility Lower Extremity Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Adult version 2.0) Mobility Lower Extremity Domain assesses an adult's self-perceived ability to perform physical tasks related to mobility and lower extremity function, such as getting out of a chair or walking. This measure uses a standard scale to assess lower extremity mobility by asking about mobility activities over the past seven days. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10. Higher scores indicate greater mobility. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 minus baseline |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Score (Pediatric and Parent Proxy Version 2.0) - Fatigue Domain | The Patient Reported Outcome Measurement Information System (PROMIS) (Pediatric and Parent Proxy version 2.0) Fatigue domain assess the level and impact of fatigue in children and adolescents, with the Pediatric version being self-reported by children aged 8-17 and the Parent Proxy version completed by a parent or guardian for their child aged 5-17. This measure uses a standard scale to assess the level of fatigue over the past seven days. Each item is rated on a 5-point scale (1-5). The scores are then summed and converted into a T-score, with a mean of 50 and standard deviation of 10 based on a US general population. Higher scores indicate worsening fatigue. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 |
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| Secondary | Change in Patient Reported Outcome Measurement Information System (PROMIS) - Short Form - Fatigue 13a (Adult FACIT 13a v1.0) | The Patient Reported Outcome Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale is a 13-item patient-reported outcome (PRO) questionnaire that captures the individual's subjective experience of their fatigue. The fatigue domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates less fatigue. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. | Modified intent to treat population | Posted | Median | Full Range | T-Score | Week 48 |
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| Secondary | Proportion of Participants With Change in Activities of Daily Living (ADL) Questions | Proportion of participants with change in activities of daily living (ADL) questions from baseline to week 48 was assessed using a study developed questionnaire. Participants and/or caregivers were asked to provide a list of three activities of daily living that were affected by fibrous dysplasia skeletal features at home or school/work (e.g., mobility, climbing stairs, dressing, playing with peers, catching a bus, etc.) and to rate the extent of impact upon their activity level using one of the option:
These activities were assessed at baseline, then reassessed at Week 24 and Week 48. Analysis was done as proportion of participants reporting "much improved" or "very much improved" in Activities of Daily Living Questions. Change = Week 48 minus baseline. | Modified intent to treat population | Posted | Number | Proportion of participants | Week 48 minus baseline |
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|
|
| 0 |
| 12 |
| 2 |
| 12 |
| 12 |
| 12 |
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
|
| GLUTEUS_MEDIUS_RIGHT |
|
|
| GLUTEUS_MEDIUS_LEFT |
|
|
| GLUTEUS_MAXIMUS_RIGHT |
|
|
| GLUTEUS_MAXIMUS_LEFT |
|
|
| HAMSTRINGS_RIGHT |
|
|
| HAMSTRINGS_LEFT |
|
|
| ANKLE_PLANTAR_FLEXORS_RIGHT |
|
|
| ANKLE_PLANTAR_FLEXORS_LEFT |
|
|
| NECK_EXTENSORS_RIGHT |
|
|
| NECK_EXTENSORS_LEFT |
|
|
| TRAPEZIUS_RIGHT |
|
|
| TRAPEZIUS_LEFT |
|
|
| DELTOID_RIGHT |
|
|
| DELTOID_LEFT |
|
|
| BICEPS_BRACHII_RIGHT |
|
|
| BICEPS_BRACHII_LEFT |
|
|
| ILIOPSOAS_RIGHT |
|
|
| ILIOPSOAS_LEFT |
|
|
| QUADRICEPS_RIGHT |
|
|
| QUADRICEPS_LEFT |
|
|
| WRIST_FLEXORS_RIGHT |
|
|
| WRIST_FLEXORS_LEFT |
|
|
| WRIST_EXTENSORS_RIGHT |
|
|
| WRIST_EXTENSORS_LEFT |
|
|
| HALLUCIS_LONGUS_EXTENSOR_RIGHT |
|
|
| HALLUCIS_LONGUS_EXTENSOR_LEFT |
|
|
| ANKLE_DORSIFLEX_RIGHT |
|
|
| ANKLE_DORSIFLEX_LEFT |
|
|
|
| SHOULDER_INTERNAL_ROTATION_RIGHT |
|
|
| SHOULDER_INTERNAL_ROTATION_LEFT |
|
|
| SHOULDER_EXTERNAL_ROTATION_RIGHT |
|
|
| SHOULDER_EXTERNAL_ROTATION_LEFT |
|
|
| ELBOW_FLEXION_RIGHT |
|
|
| ELBOW_FLEXION_LEFT |
|
|
| ELBOW_EXTENSION_RIGHT |
|
|
| ELBOW_EXTENSION_LEFT |
|
|
| WRIST_FLEXION_RIGHT |
|
|
| WRIST_FLEXION_LEFT |
|
|
| WRIST_EXTENSION_RIGHT |
|
|
| WRIST_EXTENSION_LEFT |
|
|
| HIP_FLEXION_RIGHT |
|
|
| HIP_FLEXION_LEFT |
|
|
| HIP_EXTENSION_RIGHT |
|
|
| HIP_EXTENSION_LEFT |
|
|
| HIP_EXTENSION_ROTATION_RIGHT |
|
|
| HIP_EXTENSION_ROTATION_LEFT |
|
|
| HIP_INTERNAL_ROTATION_RIGHT |
|
|
| HIP_INTERNAL_ROTATION_LEFT |
|
|
| HIP_ABDUCTION_RIGHT |
|
|
| HIP_ABDUCTION_LEFT |
|
|
| KNEE_FLEXION_RIGHT |
|
|
| KNEE_FLEXION_LEFT |
|
|
| KNEE_EXTENSION_RIGHT |
|
|
| KNEE_EXTENSION_LEFT |
|
|
| ANKLE_PLANTARFLEXION_RIGHT |
|
|
| ANKLE_PLANTARFLEXION_LEFT |
|
|
| ANKLE_DORSIFLEXION_RIGHT |
|
|
| ANKLE_DORSIFLEXION_LEFT |
|
|