Osteoporosis
Conditions
Interventions
Group 1:Sequential intravenous administration of ZOL injection for 2 years
Group 2:Sequential administration of oral BP medication for 2 years
Group 3:Sequential administration of DMAb via subcutaneous injection for 1 year followed by sequential administration of ZOL via intravenous injection for 1 year
Sponsors
Shanghai Yangpu District Central Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Males and postmenopausal females (at least 2 years postmenopause) aged 50–85 years (inclusive) at the time of informed consent signing. 2.Received at least 1 year of DMAb therapy, last injection within 6 months. 3.DEXA-measured vertebral, hip, and FN-BMD T-scores <= -3.0. 4.No prior treatment with alendronate sodium or other bisphosphonates (BPs). Women who used oral BPs for 3 months to 3 years, with the last dose at least 1 year prior to enrollment, or those who used oral BPs for no more than 3 months, are also eligible. 5.General condition is good; independent in all activities of daily living. 6.Able to attend follow-up visits as required by the study. 7.Willing to sign a written informed consent form and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Study participants meeting any of the following criteria shall be excluded from this trial: Subjects with any of the following medical histories: Significant cardiovascular and cerebrovascular disease history, defined as any of the following events occurring within 6 months prior to screening: myocardial infarction, coronary angioplasty or coronary artery bypass grafting, valvular heart disease or heart valve repair surgery, clinically significant unstable arrhythmia, unstable angina, transient ischemic attack, cerebrovascular accident; congestive heart failure classified as New York Heart Association (NYHA) Class III or IV; uncontrolled hypertension despite stable-dose antihypertensive medication administered for at least 4 weeks at screening (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg at screening); confirmed history of psychiatric disorders; history of hemoglobinopathies (e.g., sickle cell anemia, thalassemia, sideroblastic anemia); immunocompromised subjects, including recipients of organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV) infection. 2.Abnormal liver and renal function: estimated glomerular filtration rate (eGFR) 70 U/L or alanine aminotransferase (ALT) >80 U/L. 3.Diseases causing secondary osteoporosis, including thyroid and parathyroid disorders, postoperative gastrointestinal surgery, any type of malignant tumor (regardless of cure status), connective tissue diseases, neuromuscular diseases, etc. 4.History of medication use affecting bone metabolism: thiazolidinediones (TZDs), glucocorticoids, proton pump inhibitors, aromatase inhibitors, antiepileptic drugs, aluminum preparations, heparin, cyclosporin A, thyroid hormones, etc. 5.Serum 25-hydroxyvitamin D (25OHD) <12 ng/mL, hypocalcemia. 6.Contraindications to zoledronic acid (ZOL) treatment as specified in the Summary of Product Characteristics, including hypocalcemia, hypersensitivity to the active pharmaceutical ingredient, Paget's disease of bone, history of radiation therapy for skeletal disorders, tumor bone metastasis combined with hypercalcemia, etc. 7.Non-traumatic vertebral fracture or hip fracture occurring within the past 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole Hip Bone Mineral Density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone mineral density of the femoral neck;Incidence of adverse reactions;Bone turnover markers;Incidence of new vertebral fractures (as detected by imaging) and clinical non-vertebral fractures within 24 months;Bone mineral density of the lumbar and cervical spine; | — |
Countries
China
Contacts
Public ContactLige Song
Shanghai Yangpu District Central Hospital
Outcome results
None listed