This study compares the efficacy and safety of generic zoledronic acid (Yigu®) and original zoledronic acid (Aclasta®) in the treatment of postmenopausal osteoporotic women in China. Four hundred and sixty-six subjects will be randomised (1:1ratio) to either Yigu® 5mg IV or Aclasta® 5mg IV treatment arms.
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis, and it significantly reduced the risk of vertebral fractures additionally. In this research, the efficacy and safety of generic zoledronic acid injection in the treatment of postmenopausal osteoporosis will be evaluated, using original drug as control drug. It will provide evidence for reasonable clinical administrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
466
Generic Zoledronic Acid (Yigu®) 5mg/100ml injection
Original Zoledronic Acid (Aclasta®) 5mg/100ml injection
600mg/d calcium for oral daily
Change in BMD T-scores
BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time
Time frame: 12 months
Change in BMD T-scores
BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time
Time frame: 6 months
Change in Biochemical markers of bone turnover
Biochemical markers of bone turnover are determined versus baseline at the visits time. Including β-CTX and P1NP
Time frame: 14 days, 6 months and 12 months
Fractures
incidence of fracture of all parts
Time frame: 12 months
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925IU/d vitamin D for oral daily