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Denosumab Treatment for Fibrous Dysplasia

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 256 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 14 to confirmed 9
    • Primary completion date changed from estimate of Mar 11, 2026 to Nov 17, 2021
    v256
  2. 3 versions Re-verified since Oct 8, 2021, no change to tracked fieldsv253-v255
  3. Primary endpoint revised
    • Secondary endpoints revised (6)
    v252
  4. 2 versions Re-verified since Aug 5, 2021, no change to tracked fieldsv250-v251
  5. Enrollment target: 5 to 14v249
Show 42 earlier versionsHide 42 earlier versions
  1. 3 versions Re-verified since Jul 10, 2020, no change to tracked fieldsv246-v248
  2. Enrollment target: 3 to 5v245
  3. Enrollment target: estimated 14 to confirmed 3
    • Secondary endpoints: 5 to 6
    v244
  4. Primary endpoint revised
    • Secondary endpoints revised (5)
    v243
  5. Interventions: Denosumab (Drug), Denosumab (Drug), Denosumab (Drug) to Denosumab (Drug)
    • Study arms: 0 to 1
    v242
  6. Primary completion date: Mar 15, 2030 to Mar 11, 2026
    • Secondary endpoints: details revised at 5 of 5 entries
    v241
  7. Start date changed from estimate of Jun 20, 2019 to Jun 13, 2019v240
  8. Start date: Jun 19, 2019 to Jun 20, 2019v239
  9. Start date: Jun 18, 2019 to Jun 19, 2019v238
  10. Start date: Jun 17, 2019 to Jun 18, 2019v237
  11. Start date: Jun 14, 2019 to Jun 17, 2019v236
  12. Start date: Jun 13, 2019 to Jun 14, 2019v235
  13. Start date: Jun 12, 2019 to Jun 13, 2019v234
  14. Start date: Jun 11, 2019 to Jun 12, 2019v233
  15. Start date: Jun 10, 2019 to Jun 11, 2019v232
  16. Start date: Jun 7, 2019 to Jun 10, 2019v231
  17. Start date: Jun 6, 2019 to Jun 7, 2019v230
  18. Start date: Jun 5, 2019 to Jun 6, 2019v229
  19. Start date: Jun 4, 2019 to Jun 5, 2019v228
  20. Start date: Jun 3, 2019 to Jun 4, 2019v227
  21. Start date: May 30, 2019 to Jun 3, 2019v226
  22. Start date: May 29, 2019 to May 30, 2019v225
  23. Start date: May 28, 2019 to May 29, 2019v224
  24. Start date: May 27, 2019 to May 28, 2019v223
  25. Start date: May 24, 2019 to May 27, 2019v222
  26. Start date: May 23, 2019 to May 24, 2019v221
  27. Start date: May 22, 2019 to May 23, 2019v220
  28. Start date: May 21, 2019 to May 22, 2019v219
  29. Start date: May 20, 2019 to May 21, 2019v218
  30. Start date: May 17, 2019 to May 20, 2019v217
  31. Start date: May 16, 2019 to May 17, 2019v216
  32. Start date: May 15, 2019 to May 16, 2019v215
  33. Start date: May 14, 2019 to May 15, 2019v214
  34. Start date: May 13, 2019 to May 14, 2019v213
  35. Start date: May 10, 2019 to May 13, 2019v212
  36. Start date: May 9, 2019 to May 10, 2019v211
  37. Start date: May 8, 2019 to May 9, 2019v210
  38. Start date: May 7, 2019 to May 8, 2019
    • Eligibility criteria shortened, about 1 word
    v209
  39. Study Statusv208
  40. Study Statusv207
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Objectives: The primary objective of this study is to evaluate the effect of denosumab on bone turnover in individuals with fibrous dysplasia (FD). Secondary objectives are to determine the effect of denosumab on bone pain, FD lesion intensity as revealed in 18F-sodium fluoride PET/CT bone scan, and to determine the effect of denosumab discontinuation on bone turnover re-bound after discontinuation. Study Population: Up to 14 adult subjects with FD may be enrolled to ensure complete study data on 9 subjects. Design: This study is a single center, open label pilot study of once-monthly dosing of denosumab. Subjects will be treated for 6 months, after which they will be followed by an 8-month observation period. A final visit will occur 21 months after denosumab discontinuation. Dosing will be adopted from studies in adults on treatment for giant cell tumors, with denosumab administered at 120 mg per dose every 4 weeks, with loading doses on days 7 and 14 of month 1. Outcome Measures: Primary: Assessment of the effects of denosumab on: 1\. Markers of bone turnover: Beta-crosslaps C-telopeptides (bone resorption marker) Procollagen-1-propeptide (bone formation marker) Secondary: Assessment of the effects of denosumab on: 1. Bone histomorphometric indices: Mineralized perimeter Bone formation rate Cortical width Cortical area Osteoid width Osteoid perimeter Mineral apposition rate 2. Surrogate markers of a direct therapeutic effect of denosumab on FD lesions: Semi-quantitative changes in RANKL, Ki67 (marker of cell proliferation), p16 (marker of cell senescence), and/or apoptosis index before and after treatment, as assessed by immunohistochemistry Changes in sentinel lesion intensity, measured quantitatively by uptake on 18Fsodium fluoride PET/CT bone scan. 3. FD-related bone pain assessed by the Brief Pain Inventory (Short Form) , a validated self-reporting tool for assessment of pain. Exploratory Endpoints: 1. Effect of denosumab initiation and discontinuation on Serum calcium, phosphorus and parathyroid hormone Serum RANKL and osteoprotegerin (OPG), and RANKL/OPG levels 2. Effect of denosumab discontinuation, as measured by the following outcomes: Biochemical markers of bone metabolism: beta-crosslaps C-telopeptides, procollagen-1 propeptide, bone specific alkaline phosphatase, osteocalcin, NTX-telopeptides 3. Effect measured by change in other outcome measures, such as: Bone density assessed by DXA Physical Medicine and Rehabilitation evaluation
Trial Details
NCT Number NCT03571191
Lead Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Conditions
(from sponsor)		 Bone Diseases, Pain
Related terms Bone Diseases, Fibrous Dysplasia of Bone, Pain
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov