Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH

Not Applicable

• Conditions: Osteoporosis with vertebral degeneration

• Registration Number: JPRN-UMIN000007151
• Lead Sponsor: niversity of Yamanashi, Department of Orthopaedic Surgery

Brief Summary

Results: Seventy-five patients were randomized to treatment, and 66 patients completed treatment. At 4 months postoperatively, bone fusion in the 2 center CT slices was significantly higher in the teriparatide arm compared with the control arm in the age-adjusted modified intention-to-treat analysis and was significantly higher at 6 months in the per-protocol analysis. Radiographic examinations showed no disc-space narrowing and no intervertebral disc instability. JOABPEQ and ODI results were improved postoperatively in both treatment arms.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-30
• Study Completion: 2014-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified