Fibrous dysplasia of bone
Conditions
Interventions
Test group:Initially Denosumab 60-120mg, every 3 months, subcutaneous injection, adjust following regimen based on serum ALP levels
Sponsors
Shanghai sixth people's hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? Clinically diagnosed FD; ? =18 years of age and radiologically assessed epiphyseal closure; ? total alkaline phosphatase (ALP) level > the upper limit of the age-specific reference range (age =18 years old, normal reference range 15-112 U/L, Laboratory of Shanghai Sixth People's Hospital); ? 99Tc-MDP bone scan evaluated FD SBS =10%; ? Fully understand the research process, willing to cooperate with the research-related intervention and follow-up process, and sign the informed consent.
Exclusion criteria
Exclusion criteria: ? Use of Denosumab within 1 year before study start, or use of bisphosphonate within 3 years before study start for more than 1 year; ? The presence of past or current mandibular osteomyelitis or mandibular osteonecrosis, or the presence of current unhealed oral or dental surgical wounds, or the presence of active dental or mandibular lesions requiring oral surgery, or invasive oral surgery planned during the study period; ? The presence of uncorrected hypophosphatemia (serum phosphorus <0.80 mmol/L), or uncorrected hypocalcemia (serum calcium or albumin-corrected serum calcium <2.0 mmol/L), or total serum 25-hydroxy-vitamin D (25-hydroxy-vitamin D, 25OHD) <20 ng/mL (Shanghai Sixth People's Hospital Laboratory); ? A history of fracture or orthopedic surgery within 12 weeks prior to study initiation; ? The subject is currently pregnant or breastfeeding, or planned to have a child or breastfeed within 6 months from the study period to the end of treatment; ? Allergic to the investigational drug or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bone turnover markers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time required for normalizing serum ALP ;Changes in serum bone metabolism related markers of sequential zoledronic acid after discontinuation of Denosumab;change in pain;Time required for pain relief;changes in serum RANKL, OPG, RANKL/OPG ratio, calcium, phosphate and pth ;Changes in bone formation and mineralization of bone lesions;changes in lesion activity;changes in bone mineral density; | — |
Countries
China
Contacts
Public ContactZhenlin Zhang
Shanghai sixth people's hospital
Outcome results
None listed