Health Condition 1: 7- Osteopathic
Conditions
Interventions
Intervention1: Teriparatide therapy: Patients in the study group will receive Inj Teriparatide 20 mcg subcutaneous daily for a period of one year after the surgery along with Calcium (1,000 1,200 mg)
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -Age 45 years or older -Undergoing elective single level TLIF for degenerative spine diseases -No contraindications for teriparatide
Exclusion criteria
Exclusion criteria: Preoperative use of teriparatide -Contraindications to use of teriparatide (e.g., hypercalcemia, bone metastasis, Paget disease) -History of prior lumbar surgery at the index level -Infections, tumors, trauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Spinal fusion rate at 1 year, assessed by computed tomography (CT) scan using the Brantigan-Steffee-Fraser (BSF) criteria and Bridwell criteria for fusion.Timepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes: ODI and VAS scores, SF-36 (for overall health-related quality of life), or the Roland-Morris Disability Questionnaire for lumbar spine patients, to capture more comprehensive patient-reported outcomes at 3, 6, and 12 months post surgery -Monitor DEXA scan: results for changes in bone mineral density (BMD) across groups to evaluate the effectiveness of calcium and vitamin D3 in comparison to teriparatide and combination therapy. -Radiographic outcomes: Assessment of other complications (screw loosening, cage subsidence, cage back out adjacent vertebral fractures) through CT and X-rays -Adverse events: Frequency and severity of any side effects or complications related to teriparatide Timepoint: one year | — |
Countries
India
Contacts
Public ContactDr Sudhir G
Sri Ramachandra Institute of Higher Education and Research
Outcome results
None listed