Efficacy and Safety of Minodronate in Patients With Low Back Pain

Exclusion Criteria

• •1. Patient who are allergic to minodronate, alendronate, or other bisphosphonate drug or any other component of the drug under evaluation;
• •2. Patients with a diagnosis of secondary OP;
• •3. The following drugs affecting bone metabolism were used before the screening:
• •Received injections of bisphosphonate and denosumab within 3 years; Received oral bisphosphonate, parathyroid hormones or analogues, strontium, or fluoride within 6 months; Received glucocorticoids, steroids, immunosuppressants, calcitonin, calcitriol or its analogues, thiazide diuretics, and ng-acting oestrogen/progesterone replacement therapy within 3 months;
• •4. Patients with a diagnosis of diseases affecting bone metabolism (e.g., osteogenesis imperfecta, malignancy, progressive diaphyseal dysplasia, Paget's disease, rheumatoid arthritis, osteosclerosis, osteoporosis with a slipped disc and spinal stenosis, and liver and kidney failure);
• •5. Patients are participating or have participated in an investigational drug study within 3 months before signing the informed consent form;
• •6. Patients under 75 years old with a creatinine clearance rate \< 60 mL/min and those \> 75 years old with a creatinine clearance rate \< 45 mL/min;
• •7. Serum calcium levels \< 2.0 mmol/L (8 mg/dL) or \> 2.7 mmol/L (11.0 mg/dL);
• •8. Patients with fever, severe infection, severe trauma, or major surgery within 30 days;
• •9. Patients with a QTc interval of \> 480 ms;
• •10. Patients are undergoing or planning to undergo invasive dental treatment;
• •11. Smoking history in the past six months;
• •12. Patients with a history of alcohol abuse (\> 15 g of alcohol per day, equivalent to 350 mL of beer or 150 mL of wine, more than twice per week) and drug abuse;
• •13. Patients with a prior history of cerebral infarction, ischaemic or haemorrhagic stroke;
• •14. Patients with implants and/or fractures in the lumbar spine or hip that interfere with BMD testing;
• •15. Received pain relievers (e.g., nonsteroidal anti-inflammatory drugs, central analgesics) or life interventions to relieve pain within 1 week before screening;