Denosumab Treatment for Fibrous Dysplasia

This is an interventional treatment trial for Bone Diseases focused on measuring Bone Diseases, Fibrous Dysplasia (FD), Bone Turnover Read More

• INCLUSION CRITERIA:

  1. Age > or equal to 18 years
  2. Skeletal maturity with fusion of epiphyses documented radiographically
  3. Concomitant enrollment in the companion Screening and Natural History protocol 98-D-0145
  4. Confirmed diagnosis of Fibrous Dysplasia
  5. Self-reported FD-related bone pain at a site of FD, present for at least 3 months
  6. Ability to understand and provide informed consent
  7. Willing and able to complete the protocol scheduled assessments and medication regimen
  8. Willing and able to take calcium and vitamin D supplements provided by NIH
  9. Women of child bearing potential must use two forms of acceptable contraception: hormonal contraception (birth control pills, injected hormones or vaginal ring); intrauterine device and/or barrier methods (condom or diaphragm) used with spermicide. Surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner) is considered one form of contraception therefore only one other form of contraception will be required in these subjects. Verbal confirmation will be obtained at screening that two forms of acceptable contraception are being used, and that the subjects agree to use the two forms of contraception from the time they sign study consent through five months after study completion (19 months total).
  10. Serum calcium or albumin-adjusted serum calcium within the normal range for the NIH laboratory.

EXCLUSION CRITERIA:

1. Administration of denosumab within the previous year
2. Use of bisphosphonates within one year prior to first day of the denosumab administration (Day 0). Examples of bisphosphonates include: pamidronate (Aredia), Alendronate (Fosamax) and Zoledronate (Zomata).
3. Prior history, or current evidence, of osteomyelitis/osteonecrosis of the jaw or presence of an active dental or jaw condition which requires oral surgery
4. Planned invasive dental procedure for the course of the study
5. Presence of non-healed dental or oral surgery
6. Orthopedic procedure performed less than 12-weeks prior to first day of the denosumab administration (Day 0)
7. Acute fracture less than 12-weeks prior to first day of the denosumab administration (Day 0)
8. 25-hydroxyvitamin D level than 30 ng/mL (patients will be eligible for re-screening after a repletion period lasting no longer than 6 months)
9. Untreated or inadequately treated hypophosphatemia, defined as serum phosphate levels below the NIH normal range (patients will be eligible for re-screening after initiation or optimization of phosphorus replacement no longer than 6 months)
10. Subject is pregnant or breast feeding, or planning to become pregnant or breastfeed while on study and through 5 months after completion of treatment
11. Use of another investigational agent within the last 3 months prior to the first day of the denosumab administration (Day 0)
12. Subject has known sensitivity to any of the products to be administered during the study (e.g. polyketide antibiotics, mammalian derived products, calcium, or vitamin D)