Osteoporosis, Postmenopausal
Conditions
Keywords
zoledronic acid, Yigu, Aclasta, Osteoporosis, Postmenopausal, BMD, fracture, Biochemical markers
Brief summary
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.
Detailed description
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.
Interventions
DRUGGeneric Zoledronic Acid
Generic Zoledronic Acid (Yigu®) 5mg/100ml injection
DRUGOriginal Zoledronic Acid
Original Zoledronic Acid (Aclasta®) 5mg/100ml injection
DIETARY_SUPPLEMENTcalcium
600mg/d calcium for oral daily
DIETARY_SUPPLEMENTvitamin D
925IU/d vitamin D for oral daily
Sponsors
Cttq
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
46 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women between the ages of 46 and 80（cessation of menses for 12 months for any reason） * Subjects with osteoporosis diagnosed according to the World Health Organization (WHO) criteria：they had a BMD T-score of -2.5 or less at the spine or femoral neck；or they had low bone mass，defined as BMD T-score less than -1.0 and more than -2.5 at the spine or femoral neck，with the history of fragility fracture(Fracture site included vertebra, hip,proximal humera, distal radius, distal ulna) * Subjects signed informed consent voluntarily
Exclusion criteria
* Any non-primary osteoporosis skeletal disease * Subjects with abnormal hepatic function and renal function（alanine transaminase(ALT) and aspartate transaminase(AST) are 2 times higher than the upper limits of normal(ULN);plasma creatinine concentration and blood urea nitrogen are more than 1.5 ULN or calculated creatinine clearance less than 60 ml/min） * Subjects with serum calcium greater than 2.75 mmol/L (11.0 mg/dL) or less than 2.00 mmol/L (8.0 mg/dL) * Subjects with severe heart disease, blood disease, mental diseases * Subjects with cancer and other serious progressive disease * Prior therapy with bisphosphonates within 12 months before trial entry, prior therapy with parathyroid hormone 1-34 or 1-84, estrogen, selective estrogen receptor modulators, strontium more than 2 weeks within 6 months, prior therapy with oral or intravenous glucocorticoid more than 3 months within 6 months * Subject is hypersensitivity to experimental drugs, comparator drugs and their metabolites * Subjects who participated in other drugs or medical devices clinical studies as subjects within 3 months before this study * Subjects judged unfit for this study by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMD T-scores | 12 months | BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMD T-scores | 6 months | BMD T-scores (spine, hip and femoral neck) are determined versus baseline at the visits time |
| Change in Biochemical markers of bone turnover | 14 days, 6 months and 12 months | Biochemical markers of bone turnover are determined versus baseline at the visits time. Including β-CTX and P1NP |
| Fractures | 12 months | incidence of fracture of all parts |
Contacts
Primary ContactLi Mei
Outcome results
None listed