Bone LossPhase 2NCT00844480
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
A Phase 2 study testing zoledronic acid in people with Bone Loss, run by Thomas J. Schnitzer at 1 site in United States.
Trial summary
This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Loss
- What is being tested?
- zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- Age 18 years and older
- Spinal cord injury within 8 weeks of study entry
- ASIA AIS A or B
- Medically stable in the opinion of their physiatrist
- Able to have dexa performed
- Able to return for follow-up at 6 and 12 months
Who cannot join
- Vitamin D deficiency
- Hypocalcemia
- Renal insufficiency (estimated creatinine clearance <30ml/min)
- Abnormal thyroid hormone status
- Abnormal mental status
- Osteoporosis at the hip or spine by dexa
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.
- Conditions
- Bone Loss
- Being tested
- zoledronic acid, placebo
- Keywords
- spinal cord injury, osteoporosis, bone loss, zoledronic acid, bisphosphonate
- Medical subject headings
- Bone Diseases, Metabolic, Spinal Cord Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Also called Reclast, zoledronic acid
zoledronic acid, 5mg, iv
placeboDrug
iv
| Study group | Role | What they receive |
|---|---|---|
| zoledronic acid | Experimental | Not described Receives: Drug: zoledronic acid |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mass Density (BMD) at Total Hip
bone mineral density measured by DXA at the total hip
Measured: 6 months
Secondary outcomes (1)
BMD at Other Skeletal Sites
BMD at spine, femoral neck, distal femur, proximal tibia, heel
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2015
- Study completionJan 2016
Why it stopped: difficulty in enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas J. Schnitzer
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnitzer, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844480
- Sponsor's protocol ID
- RIC-TJS003
- Status last verified
- May 2017
- First submitted
- 13 Feb 2009
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schnitzer TJ, Kim K, Marks J, Yeasted R, Simonian N, Chen D. Zoledronic Acid Treatment After Acute Spinal Cord Injury: Results of a Randomized, Placebo-Controlled Pilot Trial. PM R. 2016 Sep;8(9):833-43. doi: 10.1016/j.pmrj.2016.01.012. Epub 2016 Jan 30.
PubMed 26828618
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
- ClinicalTrials.gov ID
- NCT00844480
- Acronym / sponsor ID
- RIC-TJS003
- Conditions
- Bone Loss
- Keywords
- spinal cord injury, osteoporosis, bone loss, zoledronic acid, bisphosphonate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Thomas J. SchnitzerUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Mar 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Posted 8 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zoledronic acid | Experimental | Drug: zoledronic acid |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women
- Age 18 years and older
- Spinal cord injury within 8 weeks of study entry
- ASIA AIS A or B
- Medically stable in the opinion of their physiatrist
Key exclusion criteria (6 listed)
- Vitamin D deficiency
- Hypocalcemia
- Renal insufficiency (estimated creatinine clearance <30ml/min)
- Abnormal thyroid hormone status
- Abnormal mental status
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 acidAlso: Reclast, zoledronic acidzoledronic acid, 5mg, iv | Drug | zoledronic acid |
| placeboiv | Drug | placebo |
Primary outcome
Bone Mass Density (BMD) at Total Hip
Time frame: 6 months
bone mineral density measured by DXA at the total hip
1 secondary outcome
BMD at Other Skeletal Sites
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26828618Schnitzer TJ, Kim K, Marks J, Yeasted R, Simonian N, Chen D. Zoledronic Acid Treatment After Acute Spinal Cord Injury: Results of a Randomized, Placebo-Controlled Pilot Trial. PM R. 2016 Sep;8(9):833-43. doi: 10.1016/j.pmrj.2016.01.012. Epub 2016 Jan 30.
- Individual participant dataSharing planned: Undecided
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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.
Thomas J Schnitzer, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zoledronic acid in people with Bone Loss, run by Thomas J. Schnitzer at 1 site in United States.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Jun 2017. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bone Mass Density (BMD) at Total Hip (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00844480, 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 14 Jun 2017.