Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 months
Conditions
Interventions
For osteoporosis patients who need treatment based on PBC treatment guideline, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin
Sponsors
Juntendo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 months 2)Patients given written consent after being provided with sufficient explanation about participation in this clinical trial
Exclusion criteria
Exclusion criteria: 1)Cancer patients with bone metastasis or expected bone metastasis 2) Hypocalcemia 3) Women who wish to be pregnant or are pregnant, or in lactation 4)Hypersensitivity to the denosumab 5)Cancer patients on cancer treatment or anti-hormonal therapy 6)Dental therapy during this trial 7)Long term use of bisphosphonate and have the possibility of atypical fracture 8)severe skin infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change of bone mineral density (BMD) in 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Percent change of bone metabolism markers in 6 months and 12 months 2)Correlation between serum activated vitamin D levels and BMD in 6 months and 12 months | — |
Countries
Japan
Contacts
Public ContactReiko Yaginuma
Juntendo University School of Medicine Department of Gastroenterology
Outcome results
None listed