Effects of teriparatide on screw insertion strength in spine surgery for osteoporosis
Effect of 1 Month Preoperative Teriparatide Use on the Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery
NA · The University of Hong Kong · NCT03770338
This study is testing if giving teriparatide injections to older adults with osteoporosis before spine surgery can make the screws used in the surgery hold better and improve bone strength.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 40 Years to 100 Years |
| Sex | All |
| Sponsor | The University of Hong Kong (other) |
| Drugs / interventions | radiation |
| Locations | 3 sites (Hong Kong, Please Select An Option Below and 2 other locations) |
| Trial ID | NCT03770338 on ClinicalTrials.gov |
What this trial studies
This project investigates the impact of preoperative teriparatide injections on the insertional torque strength of pedicle screws in osteoporotic patients undergoing lumbar spinal fusion. Adult patients over 40 years old will be randomized to receive teriparatide treatment for one month prior to surgery, with their bone mineral density assessed through DEXA scans. The study aims to determine whether teriparatide improves screw insertional torque and vertebral body bone mineral density before and after fusion surgery, utilizing a randomized controlled trial methodology. Follow-up assessments will occur at multiple time points post-surgery to monitor complications and fusion success.
Who should consider this trial
Good fit: Ideal candidates are osteoporotic adults over 40 years old who require lumbar spinal fusion surgery.
Not a fit: Patients with conditions such as Paget disease of bone, metabolic bone disease, or those who have had previous lumbar spine surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes for osteoporotic patients by improving screw stability during lumbar fusion surgery.
How similar studies have performed: While previous studies have explored teriparatide's effects on bone density, this specific randomized controlled trial approach to assess insertional torque is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Hong Kong, Please Select An Option Below and 2 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoporosis, Fusion of Spine, Lumbar Region, osteoporosis, teriparatide, insertional torque