Clinical trial: Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women (NCT03158246)

Eligibility 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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 46 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment