osteoporosis
Conditions
Interventions
Minodronate tablets Group:Minodronate tablets one tablet once
placebo-controlled group:Minodronate tablets placebo one tablet once
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged 46-75 years, menopause for more than 1 year, free to move; 2) Based on dual energy X-ray absorption (DXA)Determination, bone density (BMD) determination of lumbar vertebrae L1-L4 (a larger lumbar spine can be excluded in patients with bone hyperplasia and lumbar fractures and other medical history) mean T = -2.5SD, or T = -2.5SD on either side of the double hip femoral neck; 3) Understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) There are conditions that affect bone density measurement, such as severe scoliosis, bilateral hip fracture,patients after bilateral femoral neck fractures; 2) Those who are allergic to bisphosphonates or other ingredients contained in this product; 3) Endocrine diseases or other diseases affecting bone metabolism that the investigator considers inappropriate, such as clinically significant thyroid disease: parathyroidism, parathyroidism, Pagets disease, Cushing's syndrome, nephropathy Sick rickets, osteomalacia, rheumatoid arthritis, gout, multiple myeloma, osteogenesis imperfecta, etc.; 4) Estradiol =30pg/L or follicle stimulating hormone 1.5 times the upper limit of normal; 6) Patients who have taken bisphosphonate drugs within 6 months prior to enrollment or who have been taking them for more than 1 year; 7) Glucocorticoids used within 2 months prior to enrollment (local administration and no more than twice a week) calcitonin, strontium ranelate, vitamin K, active vitamin D complex, selective estrogen receptor modulators, hormone replacement therapy, and health products/natural botanicals with estrogen-like effects/ Chinese medicine, calcium-regulated immune preparations (such as environmentally friendly, tacrolimus, etc.) or methotrexate patients; 8) Dental surgery that damages the humerus such as tooth extraction during the first 2 months of enrollment or during the trial; 9) Patients with severe gastrointestinal absorption dysfunction such as dysphagia, esophagitis, enteritis or peptic ulcer; 10) Patients with delayed obstruction of the esophagus, such as narrow or loose esophagus; 11) Patients with abnormal liver function (ALT or AST > 2.5 times the upper limit of normal); 12) Patients with abnormal renal function (Cr> upper limit of normal or Ccr<60ml/min); 13) Patients with diabetes with poor glycemic control (fasting venous blood glucose =9mmol/L); 14) serum calcium is higher than 2.7mmol/L, or less than 2.0mmol/L patients; 15) Patients with known, suspected or previously malignant tumors; 16) Patients with more than 3 fractures or fractures within 3 months of previous fractures; 17) Patients with mental and neurological diseases; 18) Patients with a history of alcohol and drug abuse; 19) Other patients that the investigator believes are not suitable for enrollment, such as frequent changes in working environment and unstable living environment; 20) Patients who participated in other drug clinical studies in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average rate of bone mineral density change of lumbar vertebrae was compared between 48 weeks after administration and before administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone formation index changes after baseline treatment: bone-specific alkaline phosphatase (BAP) and serum type I collagen amino terminal peptide (PINP);Bone resorption index changes in baseline after treatment: plasma anti-tartaric acid phosphatase (TPACP);Vertebral fracture rate;Cervical femoral neck bone mineral density change rate;Proportion of bone mass improvement subjects: Proportion of subjects with a pre-treatment T score = -2 SD and a post-treatment T score > -2 SD. The lumbar spine T score and the hip femoral neck T score were calculated separately.; | — |
Countries
China
Contacts
Public ContactYingfang Zhou
Peking University First Hospital
Outcome results
None listed