Clinical investigation to examine the effect of bone formation of PTH on multilevel spinal implant surgery for vertebral degenerative disease associated with osteoporosis
- Conditions
- Vertebral degeneration associated with Osteoporosis
- Registration Number
- JPRN-UMIN000015202
- Lead Sponsor
- 1.University of Yamanashi2.Hamamatsu University School of Medicine3.Shinshu University, School of Medicine1-3Department of Orthopaedic Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fusion rate <br>Rate of intervertebral disc narrowing and instability <br>Occurrence rate of screw loosening
- Secondary Outcome Measures
Name Time Method ADL and QOL <br>femoral bone mineral density <br>bone metabolic markers