Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery (NCT05415657) | Clinical Trial Compass
CompletedNot Applicable
Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery
China76 participantsStarted 2020-01-12
Plain-language summary
Degenerative lumbar spinal diseases have become a common health problem and the most frequent indication for spinal surgery in elderly individuals. It mainly contain lumbar spinal stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis. Our study was to explore denosumab effect on bone quality and functional status in osteopenia patients with lumbar degenerative diseases after lumbar fusion surgery.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants aged 40 to 85 years
* who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
* osteopenia with BMD T score between -1.0 and -2.5 via dual-energy X-ray
* low back pain or leg numbness or weakness
* MRI demonstrated signs of nerve compression
Exclusion Criteria:
* cauda equina syndrome
* progressive neurologic deficit
* history of cancer
* scoliosis greater than 15°
* back open surgery history
* have contraindications for surgery
* who had anti-osteoporosis medication within 6 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lumbar bone mineral density (BMD)
Timeframe: up to 12 months
2
Total hip BMD
Timeframe: up to 12 months
3
Femoral neck BMD
Timeframe: up to 12 months
4
Type 1 n-terminal propeptide P1NP
Timeframe: up to 12 months
5
C-terminal crosslinking type 1 collagen terminal peptide CTX