OsteoporosisPhase 4NCT05203588
Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion
A Phase 4 study testing Denosumab 60 mg/ml Injectable Solution [Prolia] and calcium and vitamin D in people with Osteoporosis and Fusion of Spine, Lumbar Region, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Fusion of Spine, Lumbar Region
- What is being tested?
- Denosumab 60 mg/ml Injectable Solution [Prolia] and calcium and vitamin D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2021to Oct 2023
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of degenerative lumbar diseases with symptoms of low-back pain and/or leg pain for at least 3 months, which was not be adequately controlled by nonoperative treatments.
- Diagnosis of osteoporosis, defined as a bone mineral density (BMD) at lumbar or femoral neck with 2.5 standard deviations or more below the mean peak bone mass (T scores <-2.5 SD) measured by dual-energy X-ray absorptiometry (DXA).
- Patients will be underwent single-level or two-level lumbar interbody fusion.
Who cannot join
- Paget disease of bone,
- Low laboratory tests for calcium,
- Previous radiation treatment or fusion surgery to lumbar spine,
- Bone tumors,
- Bone infection,
- Acute vertebral fractures
Show all 12Show fewer
- Severe spinal deformities such as degenerative scoliosis,
- Other metabolic bone disease,
- History of a anti-osteoporosis medication
- Combined with severe morbidities,
- Uncorrected bleeding diatheses
- Application of steroids.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Lvping Sun, 021-81885070, shczkykxs@163.com
About this study
Official title: The Effects of Denosumab on Bone Fusion and Bone Metabolism in Osteoporotic Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation. Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant fixation failure, and vertebral compression fractures above or below the fusion sites.
Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone destruction and has been found to be effective in treating osteoporosis, including reducing bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few studies focus on the effects of Denosumab on lumbar fusion. In this study, we include osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. The patients were randomized to either treatment of Denosumab or no treatment. All these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we detect bone metabolism and bone fusion of these patients. Finally, we would report whether Denosumab can improve bone metabolism and promote bone fusion or not.
- Conditions
- Osteoporosis, Fusion of Spine, Lumbar Region
- Being tested
- Denosumab 60 mg/ml Injectable Solution [Prolia], calcium and vitamin D
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 60 mg/ml Injectable Solution [Prolia]Drug
Denosumab, 60mg(1ml), subcutaneously, totally two times, with one time at 1-week postoperatively and another time at 26-week postoperatively.
calcium and vitamin DDrug
calcium (≥1·0 g) and vitamin D (≥400 IU).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in this group are received denosumab (60 mg) subcutaneously at one week and 26 weeks after the lumbar fusion surgery, combined with receiving daily calcium (≥1·0 g) and vitamin D (≥400 IU). Receives: Drug: Denosumab 60 mg/ml Injectable Solution [Prolia]; Drug: calcium and vitamin D |
| Control group | Sham comparator | Patients in this group are only received daily calcium (≥1·0 g) and vitamin D (≥400 IU) after the lumbar fusion surgery. Receives: Drug: calcium and vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumbar fusion rate
Fusion rate assessed by CT scan and dynamic radiograph
Measured: 3-month post-operation
lumbar fusion rate
Fusion rate assessed by CT scan and dynamic radiograph
Measured: 6-month post-operation
lumbar fusion rate
Fusion rate assessed by CT scan and dynamic radiograph
Measured: 9-month post-operation
lumbar fusion rate
Fusion rate assessed by CT scan and dynamic radiograph
Measured: 12-month post-operation
Secondary outcomes (5)
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
To assess bone metabolism, serum samples will be collected under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.
Measured: pre-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.
Measured: 3-month post-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.
Measured: 6-month post-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.
Measured: 9-month post-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
To assess bone metabolism, serum samples will be collected before and after surgery under nonfasting conditions, and the concentrations of β-CTX) and osteocalcin (OCN) will be measured using ELISA as biomarkers of bone resorption and formation, respectively.
Measured: 12-month post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start9 Oct 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (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 Shanghai Changzheng HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changgui Shi, M.D., Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203588
- Sponsor's protocol ID
- 2021SL031
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Denosumab on Bone Fusion and Bone Metabolism in Osteoporotic Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT05203588
- Acronym / sponsor ID
- 2021SL031
- Conditions
- Osteoporosis, Fusion of Spine, Lumbar Region
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Jan 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.
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation. Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant fixation failure, and vertebral compression fractures above or below the fusion sites.
Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone destruction and has been found to be effective in treating osteoporosis, including reducing bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few studies focus on the effects of Denosumab on lumbar fusion. In this study, we include osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. The patients were randomized to either treatment of Denosumab or no treatment. All these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we detect bone metabolism and bone fusion of these patients. Finally, we would report whether Denosumab can improve bone metabolism and promote bone fusion or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Denosumab 60 mg/ml Injectable Solution [Prolia], Drug: calcium and vitamin DPatients in this group are received denosumab (60 mg) subcutaneously at one week and 26 weeks after the lumbar fusion surgery, combined with receiving daily calcium (≥1·0 g) and vitamin D (≥400 IU). |
| Control group | Sham comparator | Drug: calcium and vitamin DPatients in this group are only received daily calcium (≥1·0 g) and vitamin D (≥400 IU) after the lumbar fusion surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of degenerative lumbar diseases with symptoms of low-back pain and/or leg pain for at least 3 months, which was not be adequately controlled by nonoperative treatments.
- Diagnosis of osteoporosis, defined as a bone mineral density (BMD) at lumbar or femoral neck with 2.5 standard deviations or more below the mean peak bone mass (T scores <-2.5 SD) measured by dual-energy X-ray absorptiometry (DXA).
- Patients will be underwent single-level or two-level lumbar interbody fusion.
Key exclusion criteria (12 listed)
- Paget disease of bone,
- Low laboratory tests for calcium,
- Previous radiation treatment or fusion surgery to lumbar spine,
- Bone tumors,
- Bone infection,
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 Injectable Solution [Prolia]Denosumab, 60mg(1ml), subcutaneously, totally two times, with one time at 1-week postoperatively and another time at 26-week postoperatively. | Drug | Experimental group |
| calcium and vitamin Dcalcium (≥1·0 g) and vitamin D (≥400 IU). | Drug | Control group, Experimental group |
Primary outcome
lumbar fusion rate
Time frame: 3-month post-operation
Fusion rate assessed by CT scan and dynamic radiograph
lumbar fusion rate
Time frame: 6-month post-operation
Fusion rate assessed by CT scan and dynamic radiograph
lumbar fusion rate
Time frame: 9-month post-operation
Fusion rate assessed by CT scan and dynamic radiograph
lumbar fusion rate
Time frame: 12-month post-operation
Fusion rate assessed by CT scan and dynamic radiograph
5 secondary outcomes
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
Time frame: pre-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
Time frame: 3-month post-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
Time frame: 6-month post-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
Time frame: 9-month post-operation
Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)
Time frame: 12-month post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Changgui Shi, M.D. principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab 60 mg/ml Injectable Solution [Prolia] and calcium and vitamin D in people with Osteoporosis and Fusion of Spine, Lumbar Region, run by Shanghai Changzheng 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 3 inclusion and 12 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 24 Jan 2022. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lvping Sun (021-81885070, shczkykxs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lumbar fusion rate (time frame: 3-month post-operation). The study lists 4 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 24 Jan 2022.