Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,262
Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
Oral tablet once a week for 24 months
Unnamed facility
Fukuoka, Japan
Unnamed facility
Osaka, Japan
Unnamed facility
Sapporo, Japan
Unnamed facility
Tokyo, Japan
Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo
Time frame: Baseline to 24 months
The Percentage of Non-vertebral Fractures
The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures
Time frame: Baseline to 24 Months
Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.
The results are expressed as a percentage by Kaplan-Meier estimate.
Time frame: Baseline to 24 Months
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