Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

• Status: Unknown status
• Trial end date: 2020-03-02
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cttq
• Treatments: Calcium; Calcium, Dietary; Diphosphonates; Ergocalciferols; Vitamin D; Vitamins; Zoledronic Acid

Criteria

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