OsteoporosisNCT03770338
Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery
A study testing Teriparatide in people with Osteoporosis and Fusion of Spine, Lumbar Region, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Osteoporosis, Fusion of Spine, Lumbar Region
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 3 sitesHong Kong
- Study dates
- 1 Mar 2019to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Jason Pui Yin Cheung
Hong Kong, Please Select An Option Below
Duchess of Kent Children's Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
Official title: Effect of 1 Month Preoperative Teriparatide Use on the Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery
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.
Read the 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.
- Conditions
- Osteoporosis, Fusion of Spine, Lumbar Region
- Being tested
- Teriparatide
- Keywords
- osteoporosis, teriparatide, insertional torque
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
20ug dosage daily injection, 1-month preoperative
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Recruitment for fusion surgery as usual |
| Teriparatide | Experimental | Preoperative 1 month use of teriparatide, before lumbar fusion surgery Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertional torque Intraoperative insertional torque measurement
Measurement of the insertional torque of pedicle screws
Measured: Intraoperative
Secondary outcomes (11)
Bone Mineral Density (BMD)
Assessment of BMD before and after treatment
Measured: Preoperative, Immediate postop and 6 month postop dual energy x-ray absorptiometry (DEXA) scan
Complication rate
screw loosening, fracture, non-union
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Fusion rate
Fusion rate assessment
Measured: At 6 months CT
EQ-5D-5L
Utility score
Measured: Baseline, immediate, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Oswestry Disability Index (ODI)
Assessment of disability
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Short form 36-item questionnaire (SF-36)
General quality of life score
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Numeric Rating Scale (NRS)
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).
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)
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.
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Ambulatory status assessment (ASA)
Functional assessment
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Adherence evaluation of osteoporosis treatment (ADEOS)
Osteoporosis treatment assessment
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Osteoporosis attitude and knowledge questionnaire
To assess patients' understanding of the disease and their views towards osteoporosis
Measured: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Mar 2019
- Primary completion31 Mar 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To detect any significant difference between control and teriparatide groups in terms of intraoperative insertional torque strength
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770338
- Sponsor's protocol ID
- Teriparatide_RCT
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2018
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 1 Month Preoperative Teriparatide Use on the Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT03770338
- Acronym / sponsor ID
- Teriparatide_RCT
- Conditions
- Osteoporosis, Fusion of Spine, Lumbar Region
- Keywords
- osteoporosis, teriparatide, insertional torque
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To detect any significant difference between control and teriparatide groups in terms of intraoperative insertional torque strength
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Recruitment for fusion surgery as usual |
| Teriparatide | Experimental | Drug: TeriparatidePreoperative 1 month use of teriparatide, before lumbar fusion surgery |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: Forteo20ug dosage daily injection, 1-month preoperative | Drug | Teriparatide |
Primary outcome
Insertional torque Intraoperative insertional torque measurement
Time frame: Intraoperative
Measurement of the insertional torque of pedicle screws
11 secondary outcomes
Bone Mineral Density (BMD)
Time frame: Preoperative, Immediate postop and 6 month postop dual energy x-ray absorptiometry (DEXA) scan
Complication rate
Time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Fusion rate
Time frame: At 6 months CT
EQ-5D-5L
Time frame: Baseline, immediate, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Oswestry Disability Index (ODI)
Time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
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
Numeric Rating Scale (NRS)
Time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
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
Ambulatory status assessment (ASA)
Time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
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 attitude and knowledge questionnaire
Time frame: Baseline, immediate postop, postop 6 weeks, postop 3 months, postop 6 months, postop 12 months, postop 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teriparatide in people with Osteoporosis and Fusion of Spine, Lumbar Region, run by The University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertional torque Intraoperative insertional torque measurement (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.