OsteopeniaPhase 3NCT05638399
Denosumab vs Zoledronate After Lumbar Fusion
A Phase 3 study testing Denosumab 60 mg/ml [Prolia] and Zoledronate in people with Osteopenia and Lumbar Spondylolisthesis, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteopenia, Lumbar Spondylolisthesis
- What is being tested?
- Denosumab 60 mg/ml [Prolia] and Zoledronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2020to 28 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 40 to 85 years
- who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
- osteopenia with BMD T score between -1 and -2.5 via dual energy X-ray
- low back pain or leg numbness or weakness
- MRI demonstrated signs of nerve compression
- patients with one or two level symptoms.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShenzhenPH
Shenzhen, Guangdong, 518000
Hongyu Wang, Doctor, 18241651300, wanghongyu790039663@126.com
Song Wang, Master, 18085243269, 2362380008@qq.com
About this study
Official title: Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery
The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.
Read the detailed description
Lumbar degenerative disease including spinal stenosis and lumbar spondylolisthesis were the most common reason lead to older patients disability, which was the main indication for older patients to perform lumbar fusion surgery. For patients with lumbar degenerative disease older than 50 years old, a proportion of patients had osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.
- Conditions
- Osteopenia, Lumbar Spondylolisthesis
- Being tested
- Denosumab 60 mg/ml [Prolia], Zoledronate
- Medical subject headings
- Bone Diseases, Metabolic, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 60 mg/ml [Prolia]Drug
Also called Denosumab 6 month/subcutaneous
60 mg subcutaneously per 6 month
ZoledronateDrug
Also called Zoledronic acid
5mg, intravenous infusion once a year
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | denosumab (60 mg subcutaneously, per 6 month) Receives: Drug: Denosumab 60 mg/ml [Prolia] |
| zoledronate | Active comparator | zoledronate (5mg, intravenous infusion once a year) Receives: Drug: Zoledronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar bone mineral density(BMD)
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray
Measured: up to 12 months
Total hip BMD
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray
Measured: up to 12 months
Femoral neck BMD
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Measured: up to 12 months
Procollagen type 1 n-terminal propeptide (P1NP)
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery
Measured: up to 12 months
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Measured: up to 12 months
Visual analog scale (VAS) back
The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Measured: up to 12 months
Secondary outcomes (6)
The Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is scored by 24 adding up the number of items checked "yes" on different low back pain-related daily activity disabilities. Total scores range from 0 to 24, with higher scores 24 indicating a higher level of disability related to low back pain and lowest 0 represents no back pain.
Measured: up to 12 month
The QUALEFFO-31 Questionnaire
The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), which contains three domains including pain, physical function, and mental function. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest.
Measured: up to 12 month
The EQ-5D Questionnaire
The EuroQol five-dimension (EQ-5D) questionnaire evaluates health status consisting five dimensions: mobility, selfcare, performance of usual activities, pain or discomfort, and anxiety or depression. After conversion, the index was between 0 and 1.0 (minimum score: 0, indicating worst health state; full score:1.0, indicating full health).
Measured: up to 12 month
New fracture rate
New fracture rate containing vertebral fracture and non-vertebral fracture was assessed at 12 month after surgery. The lowest score was 0, the highest score was 100%. The lower score 0 represents no secondary fracture.
Measured: up to 12 month
Complications
Complications including cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, and recurrent symptoms were assessed.
Measured: up to 12 month
Adverse events
The main adverse events including deep venous thrombosis, pneumonia, acute renal failure, pulmonary embolism, myocardial infarction, influenza, transfer to intensive care unit, joint pain, headache, nausea, osteonecrosis of the jaw, atypical femoral fracture and rash.
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start15 Jan 2020
- Primary completion26 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Songlin Peng, Doctor, Study chair, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638399
- Sponsor's protocol ID
- ShenzhenPH spine06
- Status last verified
- Feb 2023
- First submitted
- 25 Nov 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT05638399
- Acronym / sponsor ID
- ShenzhenPH spine06
- Conditions
- Osteopenia, Lumbar Spondylolisthesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 26 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 6 Dec 2022 (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.
The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.
Detailed description
Lumbar degenerative disease including spinal stenosis and lumbar spondylolisthesis were the most common reason lead to older patients disability, which was the main indication for older patients to perform lumbar fusion surgery. For patients with lumbar degenerative disease older than 50 years old, a proportion of patients had osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: Denosumab 60 mg/ml [Prolia]denosumab (60 mg subcutaneously, per 6 month) |
| zoledronate | Active comparator | Drug: Zoledronatezoledronate (5mg, intravenous infusion once a year) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 40 to 85 years
Key exclusion criteria (7 listed)
- cauda equina syndrome
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 |
|---|---|---|
| Denosumab 60 mg/ml [Prolia]Also: Denosumab 6 month/subcutaneous60 mg subcutaneously per 6 month | Drug | Denosumab |
| ZoledronateAlso: Zoledronic acid5mg, intravenous infusion once a year | Drug | zoledronate |
Primary outcome
Lumbar bone mineral density(BMD)
Time frame: up to 12 months
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray
Total hip BMD
Time frame: up to 12 months
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray
Femoral neck BMD
Time frame: up to 12 months
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Procollagen type 1 n-terminal propeptide (P1NP)
Time frame: up to 12 months
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
Time frame: up to 12 months
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Visual analog scale (VAS) back
Time frame: up to 12 months
The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
6 secondary outcomes
The Roland-Morris Disability Questionnaire
Time frame: up to 12 month
The QUALEFFO-31 Questionnaire
Time frame: up to 12 month
The EQ-5D Questionnaire
Time frame: up to 12 month
New fracture rate
Time frame: up to 12 month
Complications
Time frame: up to 12 month
Adverse events
Time frame: up to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
Related trials for Osteopenia
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
Songlin Peng, Doctor study chair
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab 60 mg/ml [Prolia] and Zoledronate in people with Osteopenia and Lumbar Spondylolisthesis, run by Shenzhen People's Hospital at 1 site in China.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongyu Wang, Doctor (18241651300, wanghongyu790039663@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar bone mineral density(BMD) (time frame: up to 12 months). The study lists 6 primary outcomes in all. 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 21 Feb 2023.