Spinal Tuberculosis Complicated with Osteoporosis
Conditions
Interventions
Experimental Group: Standard quadruple anti-tuberculosis regimen (daily oral) +Calcium supplements (daily oral) +Vitamin D supplements (daily oral) + Denosumab (subcutaneous injection every 6 months f
Control Group:Standard quadruple anti-tuberculosis regimen (daily oral) +Calcium supplements (daily oral) +Vitamin D supplements (daily oral) + Bisphosphonate (orally once weekly for 18 months)
Sponsors
The First Affiliated Hospital of Army Medical University?
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Age 18-80 years; 2)Clinically diagnosed with spinal tuberculosis (based on patient symptoms, signs, laboratory etiological tests, and imaging examinations); 3)Dual-photon bone density scan at our hospital indicating osteoporosis (T-score < -2.5); 4)Eligible for medical treatment alone according to the Chinese Guidelines for Surgical Treatment of Spinal Tuberculosis (2022 Edition); 5)Good compliance and relatively easy follow-up.
Exclusion criteria
Exclusion criteria: 1)Clinically diagnosed with non-tuberculous infection; 2)Bone density scan excluding osteoporosis (T-score > -2.5); 3)Requiring surgical intervention according to the Guidelines for Surgical Treatment of Spinal Tuberculosis (2022 Edition); 4)Complicated with other severe infectious diseases or other conditions unsuitable for denosumab use; 5)Age 80 years; 6)Previous history of spinal tuberculosis surgery; 7)Poor compliance, difficulty in maintaining follow-up; 8)Uncontrolled comorbidities, including but not limited to: cardiac diseases: New York Heart Association (NYHA) Class II or higher, severe/unstable angina, myocardial infarction within = 6 months before study drug administration, severe arrhythmia requiring medication or intervention; uncontrolled hypertension; cerebrovascular accident or cerebral disease within = 6 months before study drug administration, or judged to have abnormal cognitive capacity; hematological diseases: coagulation abnormalities (INR > 2.0, PT > 16 s), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy; severe hepatic or renal impairment; any active infection requiring systemic anti-infective treatment within 14 days before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging-based cure rate;Systemic Bone Improvement Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Metabolism Markers;Laboratory parameters, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), hepatic and renal function;Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores; | — |
Countries
China
Contacts
Public ContactZehua Zhang
The First Affiliated Hospital of Army Medical University?
Outcome results
None listed