Vertebral degeneration associated with Osteoporosis
Conditions
Interventions
Teriparatide treatment (6 months)
Bisphosphonate treatment (6 months)
Sponsors
1.University of Yamanashi
2.Hamamatsu University School of Medicine
3.Shinshu University, School of Medicine
1-3Department of Orthopaedic Surgery
Fujiyoshida Municipal Hospital
Enshu Hospita
Hamamatsu Sekijuji Hospital
Iwata City Hospital
Jyuzen Memorial Hospital
Hamamatsu Medical Center
Narita Memorial Hospital
Shinonoi General Hospital
Azumi Hospital
Ina Central Hospital
Suwa sekijuji Hospital
Yamanashi Prefectural Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are eligilble for multilevel spinal fusion surgery for having lumbar degenerative disease (lumbar degenerative spondylolisthesis, adult spinal deformity, spinal stenosis, spondylolytic spondylolisthesis) 2. Patients 50 years of age or older at the time of signing consent form 3. Patients with osteoporosis at a high risk of fracture
Exclusion criteria
Exclusion criteria: 1.The following patients are considered to be at high risk of developing osteosarcoma (1)Patients with Paget's disease in the bone (2)Patients with high alkaline phosphatase of unknown cause (3)Patients with a history of radiotherapy which is likely to have affected the bone 2.Patients with hypercalcaemia(adjusted serum calcium level>=10.5mg/dL) 3.Patients with primary malignant osteosarcoma or metastatic bone tumor 4.Patients with metabolic bone diseases other than osteoporosis (hyperparathyroidism etc.). 5.Patients with a history of hypersensitivity to the constituents of teriparatide from subcutaneous injection. 6. Females who are pregnant or may be pregnant. 7.Patients with contraindication to bisphosphonate treatments. 8.Patients with a history of administration of denosumab or Forteo use. 9. Any other patients whom the attending physician investigator has determined to be unsuitable for the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate Rate of intervertebral disc narrowing and instability Occurrence rate of screw loosening | — |
Secondary
| Measure | Time frame |
|---|---|
| ADL and QOL femoral bone mineral density bone metabolic markers | — |
Countries
Japan
Outcome results
None listed