An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis
Not Applicable
- Conditions
- steroid induced osteoporosis
- Registration Number
- JPRN-UMIN000011461
- Lead Sponsor
- Juntendo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
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 atypical fracture 8)Severe skin infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in bone mineral density of lumber spine In case of spinal bone osteo-sclerosis or spinal bone fracture, femoral neck or distal 2th finger will be substituted Incidence rate of pathological bone fracture Fracture was validated by x-ray and/or MRI scan
- Secondary Outcome Measures
Name Time Method Change in bone metabolism markers NTX(serum , urine), bone-type alkaline phosphatase, Magnesium, Calcium, phosphorus, intact PTH, calcitonin Correlation between bone mineral density and activated vitamin D blood concentration levels Numerical rating score will be measured for pain