Osteoporosis with vertebral degeneration
Conditions
Interventions
Teriparatide treatment (6 months)
Non-treatment (6 months)
Sponsors
University of Yamanashi, Department of Orthopaedic Surgery
Shinshu University, School of Medicine, Department of Orthopaedic Surgery Hamamatsu University School of Medicine, Department of Orthopaedic Surgery
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with lumbar degenerative disease and surgical indication for one level PLIF or TLIF. 2. Patients limited only female and more than 50 years-old. 3. Patients less than 80% YAM of any site examined by DXA, or patients with fragility fracture at any site, for example on lumbar spine, femur, radius or humerus.
Exclusion criteria
Exclusion criteria: 1) The following patients considered to be at high risk of developing osteosarcoma (bone sarcoma). -Patients with Paget's disease of the bone. -Patients with high alkaline phosphatase of unknown cause. -Patients with history of radiotherapy likely to have affected the bone. 2) Patients with hypercalcaemia. 3) Patients with primary malignant osteosarcoma or metastatic bone tumor. 4) Patients with metabolic bone diseases except osteoporosis (hyperparathyroidism etc.). 5) Patients with a history of hypersensitivity to the constituents of TERIBONE for Subcutaneous Injection or other teriparatide formulations. 6) Women who are pregnant or may become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate Intervertebral disc narrowing and instability Appearance rate of screw loosening | — |
Secondary
| Measure | Time frame |
|---|---|
| ADL and QOL femoral bone mineral density bone metabolic markers | — |
Countries
Japan
Contacts
Public ContactYukihiro Isogai
ASAHI KASEI PHARMA Co. Medical Affairs Dept.
Outcome results
None listed