Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery

NCT03770338 | Recruiting

• 1 other identifier: Teriparatide_RCT
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 3

Brief Summary

This project aims to investigate any difference of insertional torque strength for osteoporotic patients with preoperative 1-month teriparatide injections versus those without. The increased insertional torque of pedicle screws during surgery after only 1 month of teriparatide use has also been studied. However, the effect of teriparatide on vertebral body bone mineral density (BMD) prior to and after fusion surgery has not been studied. The effects on screw insertional torque has also not been studied via a randomized controlled trial method.

Conditions

Osteoporosis; Fusion of Spine, Lumbar Region

Keywords

osteoporosis, teriparatide, insertional torque

Outcome Measures

Primary Outcomes (1)

• Insertional torque Intraoperative insertional torque measurement

  Measurement of the insertional torque of pedicle screws

  Intraoperative

Secondary Outcomes (11)

• Bone Mineral Density (BMD)

  Preoperative, Immediate postop and 6 month postop dual energy x-ray absorptiometry (DEXA) scan

• Complication rate

  Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months

• Fusion rate

  At 6 months CT

• EQ-5D-5L

  Baseline, immediate, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months

• Oswestry Disability Index (ODI)

  Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months

Study Arms (2)

Control

NO INTERVENTION

Recruitment for fusion surgery as usual

Teriparatide

EXPERIMENTAL

Preoperative 1 month use of teriparatide, before lumbar fusion surgery

Drug: Teriparatide

Interventions

Teriparatide DRUG

20ug dosage daily injection, 1-month preoperative

Also known as: Forteo

Teriparatide

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be osteoporotic: baseline BMD assessed by DEXA scan must be considered as osteoporotic (\>2.5 SD from sex-matched young adult, or previous vertebral and/or femoral fractures) and indicated for spinal fusion surgery

You may not qualify if:

• Paget disease of bone, high laboratory tests for serum alkaline phosphatase or calcium, previous radiation treatment or fusion surgery to lumbar spine, bone tumors, metabolic bone disease, and hypersensitivity to teriparatide

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (3)

Jason Pui Yin Cheung

Hong Kong, Please Select An Option Below, Hong Kong

RECRUITING

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To detect any significant difference between control and teriparatide groups in terms of intraoperative insertional torque strength

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 10, 2018
• Study Start: March 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-11

Locations

HK (3)