Clinical investigation to examine the effect of bone formation of PTH on multilevel spinal implant surgery for vertebral degenerative disease associated with osteoporosis

1.University of Yamanashi2.Hamamatsu University School of Medicine3.Shinshu University, School of Medicine1-3Department of Orthopaedic Surgery0 sites160 target enrollmentSeptember 18, 2014

ConditionsVertebral degeneration associated with Osteoporosis

Overview

Phase: 未知
Intervention: Not specified
Conditions: Vertebral degeneration associated with Osteoporosis
Sponsor: 1.University of Yamanashi2.Hamamatsu University School of Medicine3.Shinshu University, School of Medicine1-3Department of Orthopaedic Surgery
Enrollment: 160
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 18, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

1.University of Yamanashi2.Hamamatsu University School of Medicine3.Shinshu University, School of Medicine1-3Department of Orthopaedic Surgery

Eligibility 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

•1\.The following patients are considered to be at high risk of developing osteosarcoma
•(1\)Patients with Paget\&\#39;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.