Efficacy and Safety of Minodronate in Patients With Low Back Pain

Inclusion Criteria: Chinese postmenopausal patients with a diagnosis of OP; Patients with low back pain of at least 3 months and a VAS score ≥30; The value of lumbar L1-4 or total hip bone density measured by DXA is < -2.5; Serum 25-hydroxyvitamin D (25-OHD) concentration ≥20 ng/mL; Patients with full capacity for civil conduct and understanding of the research process and methods voluntarily participated in this study and signed the informed consent form. Exclusion Criteria: Patient who are allergic to minodronate, alendronate, or other bisphosphonate drug or any other component of the drug under evaluation; Patients with a diagnosis of secondary OP; 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; 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); Patients are participating or have participated in an investigational drug study within 3 months before signing the informed consent form; 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; Serum calcium levels < 2.0 mmol/L (8 mg/dL) or > 2.7 mmol/L (11.0 mg/dL); Patients with fever, severe infection, severe trauma, or major surgery within 30 days; Patients with a QTc interval of > 480 ms; Patients are undergoing or planning to undergo invasive dental treatment; Smoking history in the past six months; 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; Patients with a prior history of cerebral infarction, ischaemic or haemorrhagic stroke; Patients with implants and/or fractures in the lumbar spine or hip that interfere with BMD testing; Received pain relievers (e.g., nonsteroidal anti-inflammatory drugs, central analgesics) or life interventions to relieve pain within 1 week before screening;