degenerative spine spinal fusion bone health optimization osteoporosis osteoporosis related complication degenerative spine spinal fusion bone health optimization osteoporosis osteoporosis related complication teriparatide zolendronic acid randomized controlled trial
Conditions
Interventions
Participants in Group 1 will receive Teriparatide 20 micrograms (MEGAPTH) administered subcutaneously once daily from 3 months prior to scheduled surgery to 6 months postoperatively after elective spi
Experimental Drug,Experimental Drug
Teriparatide ,Zolendronic acid
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol university, Thailand
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients were eligible if they met all the 3 followings criteria 1.Postmenopausal women or men aged more than 50 years 2. Diagnosis of osteoporosis according to the American Association of Clinical Endocrinology AACE guidelines, and were indicated for anti-osteoporotic treatment, defined by at least one of the following a. T-score less than -2.5 at the lumbar spine, femoral neck, total proximal femur, or one-third radius. b. History of low-energy spine or hip fracture. c. T-score between -1.0 and -2.5 with a fragility fracture of the proximal humerus, pelvis, or distal forearm. d. T-score between -1.0 and -2.5 with a high 10 year fracture probability according to FRAX (more than 20% for major osteoporotic fracture or more than 3% for hip fracture). 3. Diagnosis of lumbar degenerative disease with failure of at least 3 months of conservative treatment and scheduled to undergo elective 1-3 levels posterior spinal fusion using PLIF and TLIF technique.
Exclusion criteria
Exclusion criteria: 1. Severe motor weakness (grade less than 3) or cauda equina syndrome 2. Diagnosed with tandem spinal stenosis requiring concomitant cervical or thoracic spine surgery 3. Previous lumbar spine surgery 4. Patients with known hypersensitivity to teriparatide or zoledronic acid 5. Patients with abnormal serum calcium levels (serum corrected calcium of less than 9mg/dL or more than 12 mg/dL) 6. Patient with chronic renal insufficiency with an estimated GFR less than 35 ml/min 7. History of active cancer 8. Patients diagnosed with spinal metastasis 9. Previous radiation therapy to the lumbar spine or a history of bone tumor 10. Patients with secondary osteoporosis 11. Patients with a history of chronic use of steroids (equivalent dose more than prednisolone 2.5 mg/day for more than 3 months) 12. Patients with unexplained high elevation of serum alkaline phosphatase 13. Previous treatment with anti-osteoporotic medication within 1 year 14. Patients who decline to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ODI (Oswestry Disability Index) 6 month ODI (Oswestry Disability Index) | — |
Secondary
| Measure | Time frame |
|---|---|
| Back pain 2 weeks, 6 weeks, 3 months, and 6 months postoperatively numerical rating scale (NRS),Leg pain 2 weeks, 6 weeks, 3 months, and 6 months postoperatively numerical rating scale (NRS),EQ-VAS (EuroQol Visual Analogue Scale) 2 weeks, 6 weeks, 3 months, and 6 months postoperatively VAS,EQ-5D-5L scores 2 weeks, 6 weeks, 3 months, and 6 months postoperatively EQ-5D-5L scores,Time to return to work 6 weeks, 3 months, and 6 months postoperatively time,Complications 2 weeks, 1 month, 6 weeks, and 6 months postoperatively incidence of wound complication, osteoporotic related complication, instrumented related complication, screw loosening, proximal junctional fracture and failure, adjacent level fracture, hypocalcemia,Fusion rate 3 months and 6 months postoperatively CT scan ,ODI (Oswestry Disability Index) 2 weeks, 6 weeks, 3 months, and 6 months postoperatively questionnaire use to measure functional disability caused by low back pain. It assesses how back pain impacts daily lifeIt consists of 10 sections with six statements in each, ranked from 0 to 5 | — |
Countries
Thailand
Contacts
Public ContactKorawish Mekariya
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed