Adult spinal deformity surgery
Conditions
Interventions
In the Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, patients who are scheduled to undergo spinal deformity surgery and have osteoporosis will be randomly assigned to rec
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at the time of surgery must be 18 years or older 2. Able to walk or use a cane 3. Patients with T-score < -2.5 SD at either femur or lumbar spine by DEXA bone mineral density measurement. Patients with a history of proximal femur fracture or vertebral fracture. Patients with other fragility fractures (distal radius fracture, proximal humerus fracture, pelvis fracture, rib fracture, tibia fracture) with a T-score < -1.0 SD. The definition of a fragility fracture is a non-traumatic fracture caused by a minor external force. The definition of a fragility fracture is a non-traumatic fracture caused by a minor external force. A minor external force is a fall from a standing position or a lesser external force. 4. Research subjects who have given written consent in person (or in the case of minors, by themselves and their guardians).
Exclusion criteria
Exclusion criteria: 1. Patients with neuromuscular diseases such as Parkinson's disease 2. Patients with syndromic scoliosis 3. Patients who have undergone surgery for spinal deformity due to infection or tumor. 4. Patients who are deemed inappropriate by the doctor in charge. 5. women who are pregnant or who wish to become pregnant 6. Patients who have already been treated with teriparatide for osteoporosis 7.Patients for whom teriparatide is contraindicated (Paget's disease of bone, unexplained high ALP levels, radiotherapy with possible effect on bone, hyper caemia, metabolic bone diseases other than osteoporosis) 8.Patients with contraindications to bisphosphonates (severe renal failure, esophageal achalasia, hypocalcemia, hypersensitivity to bisphosphonates) 9. Patients who have received Denosumab subcutaneous injection 60 mg within 6 months of obtaining consent, or Zoledronic Acid Hydrate intravenous solution 5 mg within 1 year of obtaining consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence and duration of PJF during the first postoperative year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Re-operation by PJF, Health-related QOL, Change in bone mineral density during the observation period, and adverse events | — |
Countries
Japan
Contacts
Public ContactKeiichi Nakai
Hamamatsu University School of Medicine Orthopedics Surgery
Outcome results
None listed