DRUG
Teriparatide
20ug dosage daily injection, 1-month preoperative
Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery
Status
Active, not recruiting
Phase
Not applicable
Enrollment
192
Locations
3
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
For this project, adult patients (\>40 years) undergoing lumbar spinal fusion will be randomized to undergo teriparatide treatment for 1 month prior to surgery. Patients will have their 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 to undergo study. Exclusion criteria included 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. Surgery involving single- or multi-level lumbar spinal fusion for any of the conditions: lumbar spinal stenosis, degenerative/isthmic/congenital spondylolisthesis, degenerative scoliosis. Only the surgeon and assessors will be blinded as patients will know their treatment arm. Patients undergo a quantitative CT prior to initiation of teriparatide treatment. After one month of Teriparatide treatment, the drug is discontinued with another DEXA scan to see the changes in BMD. A quantitative CT will be performed after surgery and at 6 months postoperatively. Follow-up schedules include preoperative, immediate postoperative, postoperative 6 weeks, 3 months, 6 months, 12 months and at 24 months. At all follow-up timepoints, any complications, fusion demonstrated by cross-trabeculation on x-rays (with final confirmation at the 6 month CT), and objective questionnaires for quality of life including the EuroQoL 5 dimensions 5-level questionnaire (EQ-5D-5L), back pain numeric rating scale (NRS), osteoporosis assessment questionnaire-physical function (OPAQ-PF) and ambulatory status assessment (ASA) questionnaires will be recorded. Other quality-of-life scores include ODI and SF-36, along with adherence evaluation of osteoporosis treatment (ADEOS), osteoporosis attitude questionnaire and osteoporosis knowledge questionnaire. Once a patient is identified to be suitable for this protocol, they will need to be assessed by a medical social worker to be unable to afford this entire treatment regimen before institutional support for the drug treatment is provided.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 10, 2018
Study start
Mar 1, 2019
Primary completion
Mar 31, 2026
Study completion
Jun 30, 2026
Results posted
Not reported
Registry updated
May 14, 2026
Outcomes
What the study measures.
Primary outcomes
Insertional torque Intraoperative insertional torque measurement
Time frame · Intraoperative
Measurement of the insertional torque of pedicle screws
Secondary outcomes
Bone Mineral Density (BMD)
Time frame · Preoperative, Immediate postop and 6 month postop dual energy x-ray absorptiometry (DEXA) scan
Assessment of BMD before and after treatment
Complication rate
Time frame · Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
screw loosening, fracture, non-union
Fusion rate
Time frame · At 6 months CT
Fusion rate assessment
EQ-5D-5L
Time frame · Baseline, immediate, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Utility score
Oswestry Disability Index (ODI)
Time frame · Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Assessment of disability
Short form 36-item questionnaire (SF-36)
Time frame · Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
General quality of life score
Numeric Rating Scale (NRS)
Time frame · Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
This is a self-perceived severity of back pain. The scores range from minimum 0 (no pain) to maximum 10 (most painful) in a scale of severity. Hence, a higher value represents worse outcome. There are two subquestions: 1) What the patient indicates as the most severe pain in the past 24 hours of answering the questionnaire; 2) The patient indicates the score of the usual pain status in the past 24 hours. 0 represents no pain, 1-3 represents mild pain (nagging, annoying, interfering little with ADLs), 4-6 represents moderate pain (interferes significantly with ADLs), and 7-10 represents severe pain (disabling; unable to perform ADLs).
Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)
Time frame · Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
This is a general osteoporosis score with 15 questions split into three categories (mobility, balance and transfer). A Likert scale of 6 answers are possible for each question from "no difficulties" to "unable to perform" in a scale of severity. A total score can be tabulated from adding all domain scores. Higher values indicate better outcome. A 0-100 scale provides a total score, where 0 indicates the worst health status and 100 no difficulties.
Ambulatory status assessment (ASA)
Time frame · Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Functional assessment
Adherence evaluation of osteoporosis treatment (ADEOS)
Time frame · Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Osteoporosis treatment assessment
Eligibility
Who can take part.
- Minimum age
- 40 Years
- Maximum age
- 100 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
3 registered sites.
Hong Kong. Showing up to 24 locations stored in the fast local snapshot.
Jason Pui Yin Cheung
Hong Kong, Please Select An Option Below, Hong Kong
Duchess of Kent Children's Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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