OsteoporosisNCT03330340
Percutaneous Vertebroplasty Versus Conservative Treatment in GIOPVCF
An observational study of Osteoporosis, run by Peking University First Hospital.
Trial summary
Based on the case reports and other literature, the investigators hypothesize that using PVP for treating GIOPVCF is associated with increased risk of vertebral refractures and does not provide further benefits compared to conservative treatments. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Percutaneous Vertebroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 30 Dec 2019
- Phase
- Observational
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients had fresh vertebral compression fractures with GIOP
Who may be able to join
- Patients have fresh vertebral compression fractures regarding spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone edema on MRI, focal tenderness on VCF level).
- Patients have back pain for 6 weeks or less, with a visual analogue scale (VAS) score equal or less than 5.
- GCs consumption for more than 3 months (prednisone equivalent or more than 5 mg daily).
- Reduced bone density with T-scores equal or less than -1.
- Age at 55 or higher.
- -
Who cannot join
- Concurrent other secondary osteoporosis.
- Previous PVP procedure or other spinal surgery on thoracic or lumbar segments.
- Systemic or local infection in spine (osteomyelitis, spondylodiscitis)
- Unable to comply with study due to severe psychosis.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Percutaneous Vertebroplasty Versus Conservative Treatment in Vertebral Compression Fracture Associated With Glucocorticoids-induced Osteoporosis: a Prospective Cohort Study
Based on the case reports and other literature, the investigators hypothesize that using PVP for treating GIOPVCF is associated with increased risk of vertebral refractures and does not provide further benefits compared to conservative treatments.
The overall objective of this prospective cohort study is to compare the efficacy of PVP and conservative treatment for GIOPVCF. The evaluation of efficacy of therapy includes: 1) the incidence of vertebral refractures; 2) therapeutic effects (pain relief and health-related life quality) and 3) complications.
The results from study will be written in English and disseminated widely through scholarly presentations, peer-reviewed publications, and other written communications.
Read the detailed description
Patient recruitment and informed consent The study will recruit patients with GIOPVCF after consultation with inpatients and outpatients. The principal investigator of the study will screen the clinical information and inform the patients whether they are eligible for the study. After explaining the two therapeutic strategies (conservative treatment and PVP) and signing the informed consent, the patients will be divided into conservative treatment or PVP group based on their own decision.
The general information and medicine history of the participants are collected: age, gender, original disease, the course of original disease, specific GCs that have been used, the dosage/length of the GCs treatment, specific anti-osteoporosis medicine have been used and the dosage and length of usage. The bone density of the patient will then be evaluated using Dual-energy X-ray absorptiometry (DXA).
Withdrawal of individual subject Patients can withdraw from the study at any time for any reason without any consequences. The investigator can also decide to release patients from the study for medical reasons. For every patient who decides to withdraw from the study, the reasons of withdrawal will be recorded.
Sample size calculation A p-value is less than significance level (α) of 0.05 is considered as statistically significant. The statistical power (1-β) is defined as 80%. Based on the survival analysis of primary endpoint , the incidence of refracture in the patients with GIOPVCF is 48.6% after initial PVP operation and 17% after initial conservative treatment. Thus, power analysis indicates the study requires 42 patients per group to achieve statistical significance between two groups. Considering 20% of patients may be lost during follow-up visits, the investigators will recruit 53 patients for each group.
Statistical analysis Standard statistical techniques will be used to describe characteristics of patients in both groups. The investigators will compare baseline characteristics in the two treatment groups and if incomparability appears, the investigators will in secondary analysis adjust for differences. The incidence of vertebral refracture between groups will be compared with the Kaplan Meier survival analysis. Baseline differences of pain relief and health-related life quality between two groups will be assessed using student t test or nonparametric tests. Changes of VAS, ODI, and EQ-5D within the group from baseline to every follow-up time point will be compared using paired t test. A P value less than 0.05 is considered as statistically significant. SPSS 17.0 statistical program (SPSS, Chicago, IL) will be used for statistical analysis.
- Conditions
- Osteoporosis
- Being tested
- Percutaneous Vertebroplasty
- Keywords
- vertebral compression fracture, osteoporosis, glucocorticoids, vertebroplasty
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous VertebroplastyProcedure or surgery
The procedure takes place under sterile conditions. Local anesthesia is administered from skin to the periosteum of the targeted pedicle. Polymethylmethacrylate bone cement (Mendec Spine; Tecres SPA, Sommacampagna, Italy) is injected under continuous fluoroscopic imaging guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. The amount of injected cement in each treated vertebral body and any cement leakage is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous vertebroplasty | All PVPs are performed by experienced spine surgeons under optimal fluoroscopic guidance. The procedure takes place under sterile conditions. Local anesthesia is administered to the periosteum of the targeted pedicle via skin. Polymethylmethacrylate bone cement is injected under continuous fluoroscopic guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. Patients are encouraged to stand up and walk with brace immediately after operation and the brace are required to be worn for 3 months. Furthermore, all patients will take oral bisphosphonates treatment together with supplemental calcium and vitamin D. Receives: Procedure: Percutaneous Vertebroplasty | |
| Conservative treatment | In conservative treatment group, the patients were required horizontal bed rest for the initial 2 weeks after diagnosis. Then, they were encouraged to stand up and walk with brace and assistance. The bed rest time was extended if the back pain worsened when they stood up and walked. The brace should be worn in 3 months. For pain medication, nonsteroidal anti-inflammatory drugs (NSAIDs) were prescribed for every patient. Additional analgesics, such as tramadol and morphine, would be added in case NSAIDs were not effective. Two weeks after diagnosis, physical therapy was started. All patients are put on osteoporosis medication, bisphosphonates together with supplemental calcium and vitamin D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vertebral re-fracture
Anterior-posterior and lateral spinal radiograph will be obtained. If a new vertebral fracture was doubted, MRI was undertaken to confirm it. When there is disagreement between both observers a consensus meeting is held. Incidence of vertebral re-fracture is Number of new fracture vertebrae/Number of total vertebrae
Measured: 12 months after the treatment
Secondary outcomes (1)
Visual Analog Scale (VAS) for back pain change from baseline to 12 months
All participants are asked to fill out standard questionnaires of the VAS score for back pain. The VAS pain is a single-item scale. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). The change from baseline to 12-month post treatment will be compared between two groups
Measured: 12 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (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 Peking University First 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haolin Sun, Peking University First Hospital
- Investigators
- Chunde Li, Doctor, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330340
- Sponsor's protocol ID
- HSun-1
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Vertebroplasty Versus Conservative Treatment in Vertebral Compression Fracture Associated With Glucocorticoids-induced Osteoporosis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03330340
- Acronym / sponsor ID
- HSun-1
- Conditions
- Osteoporosis
- Keywords
- vertebral compression fracture, osteoporosis, glucocorticoids, vertebroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 6 Nov 2017 (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.
Based on the case reports and other literature, the investigators hypothesize that using PVP for treating GIOPVCF is associated with increased risk of vertebral refractures and does not provide further benefits compared to conservative treatments.
The overall objective of this prospective cohort study is to compare the efficacy of PVP and conservative treatment for GIOPVCF. The evaluation of efficacy of therapy includes: 1) the incidence of vertebral refractures; 2) therapeutic effects (pain relief and health-related life quality) and 3) complications.
The results from study will be written in English and disseminated widely through scholarly presentations, peer-reviewed publications, and other written communications.
Detailed description
Patient recruitment and informed consent The study will recruit patients with GIOPVCF after consultation with inpatients and outpatients. The principal investigator of the study will screen the clinical information and inform the patients whether they are eligible for the study. After explaining the two therapeutic strategies (conservative treatment and PVP) and signing the informed consent, the patients will be divided into conservative treatment or PVP group based on their own decision.
The general information and medicine history of the participants are collected: age, gender, original disease, the course of original disease, specific GCs that have been used, the dosage/length of the GCs treatment, specific anti-osteoporosis medicine have been used and the dosage and length of usage. The bone density of the patient will then be evaluated using Dual-energy X-ray absorptiometry (DXA).
Withdrawal of individual subject Patients can withdraw from the study at any time for any reason without any consequences. The investigator can also decide to release patients from the study for medical reasons. For every patient who decides to withdraw from the study, the reasons of withdrawal will be recorded.
Sample size calculation A p-value is less than significance level (α) of 0.05 is considered as statistically significant. The statistical power (1-β) is defined as 80%. Based on the survival analysis of primary endpoint , the incidence of refracture in the patients with GIOPVCF is 48.6% after initial PVP operation and 17% after initial conservative treatment. Thus, power analysis indicates the study requires 42 patients per group to achieve statistical significance between two groups. Considering 20% of patients may be lost during follow-up visits, the investigators will recruit 53 patients for each group.
Statistical analysis Standard statistical techniques will be used to describe characteristics of patients in both groups. The investigators will compare baseline characteristics in the two treatment groups and if incomparability appears, the investigators will in secondary analysis adjust for differences. The incidence of vertebral refracture between groups will be compared with the Kaplan Meier survival analysis. Baseline differences of pain relief and health-related life quality between two groups will be assessed using student t test or nonparametric tests. Changes of VAS, ODI, and EQ-5D within the group from baseline to every follow-up time point will be compared using paired t test. A P value less than 0.05 is considered as statistically significant. SPSS 17.0 statistical program (SPSS, Chicago, IL) will be used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous vertebroplasty | – | Procedure: Percutaneous VertebroplastyAll PVPs are performed by experienced spine surgeons under optimal fluoroscopic guidance. The procedure takes place under sterile conditions. Local anesthesia is administered to the periosteum of the targeted pedicle via skin. Polymethylmethacrylate bone cement is injected under continuous fluoroscopic guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. Patients are encouraged to stand up and walk with brace immediately after operation and the brace are required to be worn for 3 months. Furthermore, all patients will take oral bisphosphonates treatment together with supplemental calcium and vitamin D. |
| Conservative treatment | – | –In conservative treatment group, the patients were required horizontal bed rest for the initial 2 weeks after diagnosis. Then, they were encouraged to stand up and walk with brace and assistance. The bed rest time was extended if the back pain worsened when they stood up and walked. The brace should be worn in 3 months. For pain medication, nonsteroidal anti-inflammatory drugs (NSAIDs) were prescribed for every patient. Additional analgesics, such as tramadol and morphine, would be added in case NSAIDs were not effective. Two weeks after diagnosis, physical therapy was started. All patients are put on osteoporosis medication, bisphosphonates together with supplemental calcium and vitamin D. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients had fresh vertebral compression fractures with GIOP
Key inclusion criteria (6 listed)
- Patients have fresh vertebral compression fractures regarding spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone edema on MRI, focal tenderness on VCF level).
- Patients have back pain for 6 weeks or less, with a visual analogue scale (VAS) score equal or less than 5.
- GCs consumption for more than 3 months (prednisone equivalent or more than 5 mg daily).
- Reduced bone density with T-scores equal or less than -1.
- Age at 55 or higher.
Key exclusion criteria (5 listed)
- Concurrent other secondary osteoporosis.
- Previous PVP procedure or other spinal surgery on thoracic or lumbar segments.
- Systemic or local infection in spine (osteomyelitis, spondylodiscitis)
- Unable to comply with study due to severe psychosis.
- -
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 |
|---|---|---|
| Percutaneous VertebroplastyThe procedure takes place under sterile conditions. Local anesthesia is administered from skin to the periosteum of the targeted pedicle. Polymethylmethacrylate bone cement (Mendec Spine; Tecres SPA, Sommacampagna, Italy) is injected under continuous fluoroscopic imaging guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. The amount of injected cement in each treated vertebral body and any cement leakage is recorded. | Procedure or surgery | Percutaneous vertebroplasty |
Primary outcome
Incidence of vertebral re-fracture
Time frame: 12 months after the treatment
Anterior-posterior and lateral spinal radiograph will be obtained. If a new vertebral fracture was doubted, MRI was undertaken to confirm it. When there is disagreement between both observers a consensus meeting is held. Incidence of vertebral re-fracture is Number of new fracture vertebrae/Number of total vertebrae
1 secondary outcome
Visual Analog Scale (VAS) for back pain change from baseline to 12 months
Time frame: 12 months after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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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.
Chunde Li, Doctor study director
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Peking University First 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 6 inclusion and 5 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 6 Nov 2017. 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?
Contact Haolin Sun, Doctor (+8613681146156, sunhaolin5@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vertebral re-fracture (time frame: 12 months after the treatment). 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 6 Nov 2017.