Image Changes of Lumbar FusionPhase 4NCT01310465
The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
A Phase 4 study testing zoledronic acid and sodium chloride in people with Image Changes of Lumbar Fusion and Bone Turnover Markers, run by Fudan University at 1 site in China.
Trial summary
Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Image Changes of Lumbar Fusion, Bone Turnover Markers, Bone Mineral Density
- What is being tested?
- zoledronic acid and sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Apr 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
- Age 50-70 years old
- Willing to sign informed consent
Who cannot join
- Application of strontium ranelate, sodium fluoride or parathyroid hormone
- Application of bisphosphonates more than 8 weeks during 2 years preoperatively
- Suffering from bone fracture during 3 months preoperatively
- Urinary creatinine clearance rate less than 35mL/min
- Serum calcium concentrations greater than 2.75mmol/L or less than 2.00mmol/L
- Pregnancy or breast-feeding women
- Suffering from cancer or other diseases that may be expected to live less than a year
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital of Fudan university
Shanghai, Shanghai Municipality, 200032
Chao Li, bachlor, 15202183944, lichao0457034@gmail.com
Chao Li, bachlor
About this study
Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers dispute if zoledronic acid can promote the healing of long bone fractures. But few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three days postoperatively, the patients were randomized to either one infusion of zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months. During this time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if zoledronic acid can modify bone metabolism and promote bone fusion.
- Being tested
- zoledronic acid, sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively
sodium chlorideDrug
sodium chloride, 100ml, intravenous, one time at three days postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously. Receives: Drug: zoledronic acid |
| Placebo Comparator | Placebo comparator | Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously. Receives: Drug: sodium chloride |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Image Changes of Lumbar FusionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310465
- Sponsor's protocol ID
- FudanU-0457034
- Status last verified
- Jan 2011
- First submitted
- 7 Mar 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colon-Emeric C, Nordsletten L, Olson S, Major N, Boonen S, Haentjens P, Mesenbrink P, Magaziner J, Adachi J, Lyles KW, Hyldstrup L, Bucci-Rechtweg C, Recknor C; HORIZON Recurrent Fracture Trial. Association between timing of zoledronic acid infusion and hip fracture healing. Osteoporos Int. 2011 Aug;22(8):2329-36. doi: 10.1007/s00198-010-1473-1. Epub 2010 Dec 9.
PubMed 21153021
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT01310465
- Acronym / sponsor ID
- FudanU-0457034
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 8 Mar 2011 (estimated)
- 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.
Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers dispute if zoledronic acid can promote the healing of long bone fractures. But few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three days postoperatively, the patients were randomized to either one infusion of zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months. During this time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if zoledronic acid can modify bone metabolism and promote bone fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: zoledronic acidThree days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously. |
| Placebo Comparator | Placebo comparator | Drug: sodium chlorideThree days postoperatively, patients in this group are given one infusion of sodium chloride intravenously. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
- Age 50-70 years old
- Willing to sign informed consent
Key exclusion criteria (7 listed)
- Application of strontium ranelate, sodium fluoride or parathyroid hormone
- Application of bisphosphonates more than 8 weeks during 2 years preoperatively
- Suffering from bone fracture during 3 months preoperatively
- Urinary creatinine clearance rate less than 35mL/min
- Serum calcium concentrations greater than 2.75mmol/L or less than 2.00mmol/L
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 |
|---|---|---|
| zoledronic acidzoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively | Drug | Experimental group |
| sodium chloridesodium chloride, 100ml, intravenous, one time at three days postoperatively | Drug | Placebo Comparator |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
- Background: PubMed 21153021Colon-Emeric C, Nordsletten L, Olson S, Major N, Boonen S, Haentjens P, Mesenbrink P, Magaziner J, Adachi J, Lyles KW, Hyldstrup L, Bucci-Rechtweg C, Recknor C; HORIZON Recurrent Fracture Trial. Association between timing of zoledronic acid infusion and hip fracture healing. Osteoporos Int. 2011 Aug;22(8):2329-36. doi: 10.1007/s00198-010-1473-1. Epub 2010 Dec 9.
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.
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 zoledronic acid and sodium chloride in people with Image Changes of Lumbar Fusion and Bone Turnover Markers, run by Fudan University 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 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 8 Mar 2011. 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 Chao Li, bachelor (15202183944, lichao0457034@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01310465, which also lists 1 linked publication.
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 8 Mar 2011.