OsteoporosisNCT05911477
Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion
A study testing RhBMP-2 in people with Osteoporosis and Spinal Fusion, run by Xijing Hospital.
Trial summary
rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoporosis, Spinal Fusion
- What is being tested?
- RhBMP-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Jun 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with degenerative lumbar diseases.
- patients underwent one-level TLIF
- osteoporosis (DXA T≤-2.5)
- complete preoperative and follow-up data (imaging and health-related quality of life)
Who cannot join
- history of previous spinal surgery
- inflammatory and neoplastic diseases
About this study
Official title: Effect of rhBMP-2 on Early Bone Formation in Patients With Osteoporosis After Lumbar Fusion
rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. However, whether it functioned in patients with osteoporosis remained unknown. In this study, the investigators intend to investigate whether rhBMP-2 promotes early bone formation in patients with osteoporosis after transforaminal lumbar interbody fusion (TLIF).
Read the detailed description
Pseudoarthrosis and many complications associated with iliac crest bone graft (ICBG) has prompted the spine surgeons to seek alternative methods to promote rate of spinal fusion. The rhBMP-2 received FDA approval in 2002 for use as an alternative to autograft for single-level anterior lumbar interbody fusion (ALIF). Many studies reported equivalent or better fusion rates. Recent studies, however, identified complications related to rhBMP-2 use such as osteolysis, graft subsidence, and retrograde ejaculation and other urological complications. Overdose of rhBMP-2 in patients may lead to complications mentioned above. A recent randomized controlled trial in 2022 confirmed a low dose usage of rhBMP-2 promoted fusion after TLIF (21.mg per fusion level) without increase in complications.
Current fusion methods achieve interbody fusion by filling the cage in the central region of the intervertebral space with bone graft material. However, the early fusion rates (at 3 and 6 months postoperatively) are often unsatisfactory. According to present literatures, the 3-month and 6-month fusion rates have ranged from 2.9% to 43.1% and 30% to 68.8%, respectively. Although a lack of fusion may be asymptomatic, it may potentially lead to complications, even a reoperation. In addition, failure to achieve early fusion may result in a delayed return to work, and reduced patient satisfaction, especially in patients with osteoporosis. Whether rhBMP-2 may lead to higher and early fusion rate in osteoporosis patient remains unknown.
In this study, the investigators intend to compare the time it takes to achieve osseous union/fusion and the clinical efficacy of using rhBMP-2 to control group in TLIF. The rhBMP-2 in the study is produced by a domestic enterprise (HANGZHOU JIUYUAN GENE ENGINEERING CO .,LTD., Hangzhou, China).
- Conditions
- Osteoporosis, Spinal Fusion
- Being tested
- RhBMP-2
- Keywords
- rhBMP-2, lumbar fusion, fusion rate, osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhBMP-2Drug
1mg RhBMP-2 for one fusion-level
| Study group | Role | What they receive |
|---|---|---|
| rhBMP-2 group | Experimental | Not described Receives: Drug: RhBMP-2 |
| No rhBMP-2 group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate at 6 months
- <5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs
- Bridging bone connecting the adjacent vertebral bodies either through the implants or around the implants, and an absence of radiolucent lines around >50% of either implant from computed tomography (CT) scans of lumbar
Measured: 6 months follow-up
Fusion rate at 3 months
<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs of radiolucent lines around >50% of either implant
Measured: 3 months follow-up
Secondary outcomes (5)
Visual Analog Score for low back pain (VAS-B)
range from 0-10, a higher score means a worse outcome.Short Form Survey (SF-36)
Measured: pre- and post-operative immediately, 3- and 6- months follow-up
Visual Analog Score for leg pain (VAS-L)
range from 0-10, a higher score means a worse outcome.
Measured: pre- and post-operative immediately, 3- and 6- months follow-up
Oswestry disability index (ODI)
range from 0-100%, a higher score means a worse outcome.
Measured: pre-operatively, 3- and 6-months follow-up
36-Item Short Form Survey (SF-36)
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36) in 1992. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Measured: pre-operatively, 3- and 6-months follow-up
Incidence of complications
infection, revision surgery, etc.
Measured: post-operative immediately, 3- and 6- months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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 Xijing 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Xueyu, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911477
- Sponsor's protocol ID
- 20222249-1
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers should ask for permissions from the investigator.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of rhBMP-2 on Early Bone Formation in Patients With Osteoporosis After Lumbar Fusion
- ClinicalTrials.gov ID
- NCT05911477
- Acronym / sponsor ID
- 20222249-1
- Conditions
- Osteoporosis, Spinal Fusion
- Keywords
- rhBMP-2, lumbar fusion, fusion rate, osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Jun 2023 (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.
rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. However, whether it functioned in patients with osteoporosis remained unknown. In this study, the investigators intend to investigate whether rhBMP-2 promotes early bone formation in patients with osteoporosis after transforaminal lumbar interbody fusion (TLIF).
Detailed description
Pseudoarthrosis and many complications associated with iliac crest bone graft (ICBG) has prompted the spine surgeons to seek alternative methods to promote rate of spinal fusion. The rhBMP-2 received FDA approval in 2002 for use as an alternative to autograft for single-level anterior lumbar interbody fusion (ALIF). Many studies reported equivalent or better fusion rates. Recent studies, however, identified complications related to rhBMP-2 use such as osteolysis, graft subsidence, and retrograde ejaculation and other urological complications. Overdose of rhBMP-2 in patients may lead to complications mentioned above. A recent randomized controlled trial in 2022 confirmed a low dose usage of rhBMP-2 promoted fusion after TLIF (21.mg per fusion level) without increase in complications.
Current fusion methods achieve interbody fusion by filling the cage in the central region of the intervertebral space with bone graft material. However, the early fusion rates (at 3 and 6 months postoperatively) are often unsatisfactory. According to present literatures, the 3-month and 6-month fusion rates have ranged from 2.9% to 43.1% and 30% to 68.8%, respectively. Although a lack of fusion may be asymptomatic, it may potentially lead to complications, even a reoperation. In addition, failure to achieve early fusion may result in a delayed return to work, and reduced patient satisfaction, especially in patients with osteoporosis. Whether rhBMP-2 may lead to higher and early fusion rate in osteoporosis patient remains unknown.
In this study, the investigators intend to compare the time it takes to achieve osseous union/fusion and the clinical efficacy of using rhBMP-2 to control group in TLIF. The rhBMP-2 in the study is produced by a domestic enterprise (HANGZHOU JIUYUAN GENE ENGINEERING CO .,LTD., Hangzhou, China).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhBMP-2 group | Experimental | Drug: RhBMP-2 |
| No rhBMP-2 group | No intervention | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients diagnosed with degenerative lumbar diseases.
- patients underwent one-level TLIF
- osteoporosis (DXA T≤-2.5)
- complete preoperative and follow-up data (imaging and health-related quality of life)
Key exclusion criteria (2 listed)
- history of previous spinal surgery
- inflammatory and neoplastic diseases
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 |
|---|---|---|
| RhBMP-21mg RhBMP-2 for one fusion-level | Drug | rhBMP-2 group |
Primary outcome
Fusion rate at 6 months
Time frame: 6 months follow-up
1. <5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs 2. Bridging bone connecting the adjacent vertebral bodies either through the implants or around the implants, and an absence of radiolucent lines around >50% of either implant from computed tomography (CT) scans of lumbar
Fusion rate at 3 months
Time frame: 3 months follow-up
<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs of radiolucent lines around >50% of either implant
5 secondary outcomes
Visual Analog Score for low back pain (VAS-B)
Time frame: pre- and post-operative immediately, 3- and 6- months follow-up
Visual Analog Score for leg pain (VAS-L)
Time frame: pre- and post-operative immediately, 3- and 6- months follow-up
Oswestry disability index (ODI)
Time frame: pre-operatively, 3- and 6-months follow-up
36-Item Short Form Survey (SF-36)
Time frame: pre-operatively, 3- and 6-months follow-up
Incidence of complications
Time frame: post-operative immediately, 3- and 6- months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. Other researchers should ask for permissions from the investigator.
Related trials for Osteoporosis
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
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.
Questions about this trial
What is this clinical trial studying?
A study testing RhBMP-2 in people with Osteoporosis and Spinal Fusion, run by Xijing Hospital.
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 4 inclusion and 2 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Fusion rate at 6 months (time frame: 6 months follow-up). The study lists 2 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 22 Jun 2023.