Bone density changes before and after administration of danozoomab
Phase 3
Completed
- Conditions
- Osteoporosis.Osteoporosis with current pathological fracture
- Registration Number
- IRCT20210803052067N1
- Lead Sponsor
- Artesh University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 202
Inclusion Criteria
Postmenopausal women (aged 45 to 75 years old) diagnosed with osteoporosis by densitometry via Dexa(dual energy Xray absorptiometry).
Exclusion Criteria
Lack of consent for being in the trial
Having hypersensitivity to denosumab or any component in the formulation
Malabsorption syndrome
History of thyroid surgery, parathyroid surgery or intestinal resection which has been caused malabsorption Patient
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in Bone mineral density(BMD) at the lumbar spine (L1-L4), femoral neck, and total hip. Timepoint: Baseline and at 12th month of the study. Method of measurement: BMD by dual-energy x-ray absorptiometry Hologic 4500 or higher.
- Secondary Outcome Measures
Name Time Method (T score). Timepoint: At the beginning of the study and12 months later. Method of measurement: Bone densitometry.