AzTrials
AzTrials

Spinal Cord InjuryPhase 3NCT01642901

Zoledronic Acid in Acute Spinal Cord Injury

A Phase 3 study testing Zoledronic acid and normal saline 0.9% in people with Spinal Cord Injury, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more effective than other agents in reducing bone mass… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Zoledronic acid and normal saline 0.9%
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2012to Mar 2018
Phase
Phase 3
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 18-65, male or female
  • Traumatic SCI with Neurological level C4-T10, American Spinal Injury Association (ASIA) Impairment Scale (AIS) A,
  • Serum calcium level >7.0 mg/dL) at time of study drug administration
  • Screening baseline serum 25-hydroxy (25-OH) vitamin D of at least 13 ng/ml
  • No medical contraindication to supplemental vitamin D for participants whose levels are >13 ng/ml but sub-therapeutic (<32ng/ml)
  • No medical contraindication to supplemental calcium
  • Weight under 300 pounds, which is the maximum permitted on the dual-energy X-ray absorptiometry (DXA) scanner

Who cannot join

  • Ventilator-dependent individuals
  • Chronic steroid use (defined as >6 months)
  • Rheumatoid disease with use of prior disease modifying anti-rheumatic drugs (DMARDs) affecting bone density
  • History of osteoporosis or of treatment for osteopenia or osteoporosis with bisphosphonates, or selective reuptake estrogen modifying agents
  • Current use of medications* including bisphosphonates to treat osteoporosis (*note that prior calcium or vitamin D use is not an exclusion criteria)
  • History of more than one lower extremity osteoporosis-related fracture
Show all 21Show fewer
  • Chronic renal insufficiency, creatinine clearance < 35 ml/min, during screening
  • End stage liver or kidney disease
  • Medical conditions resulting in hypogonadal states that affect bone density
  • Uncontrolled thyroid disease/thyrotoxicosis
  • Hereditary or acquired metabolic bone disorder
  • History of use of unfractionated heparin for >1 year
  • History of selected antiseizure medications, specifically phenobarbital, phenytoin, carbamazepine, sodium valproate >1 year
  • Acute or chronic bilateral lower extremity fractures involving tibia or femur, with placement of surgical hardware in any areas of above locations
  • Severe hypotension requiring use of intravenous blood pressure agents such as dopamine, norepinephrine or phenylephrine. Exception may allow for patients on pressors who arm experiencing hypotension as they acclimate to upright posture.
  • Inability to provide informed consent and understand the consent process
  • Facial fractures requiring oral surgery
  • Dental surgery or oral maxillofacial surgery within 2 weeks of anticipated study drug administration
  • Pregnancy present on admission
  • Vitamin D deficiency on admission testing (serum 25-OH D reported as < 13 ng/mL)
  • Patients with an established reaction to, or history of, anaphylactic shock to aspirin

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University and Hospital

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Zoledronic Acid to Prevent Bone Loss After Acute Spinal Cord Injury

Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more effective than other agents in reducing bone mass resorption and leg fractures in post-menopausal women, but has not been studied in patients with acute SCI. This will be a randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus placebo within 21 days of an SCI.

Read the detailed description

Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) has been shown to be more effective than other agents in reducing bone mass resorption and fracture of the legs in post-menopausal women, but has not been studied in acute spinal cord injury. Two previous studies of ZA in persons with subacute SCI, while promising, were inconclusive. As stated in the long range plan of the National Institute on Disability and Rehabilitation Research (NIDRR), one goal in the area of health and function is to "focus on the onset of new conditions…exacerbation of existing conditions, or the development of coexisting conditions." This study is intended to demonstrate reduction in loss of bone mass at the hip and knee regions in acute SCI in a rigorous study of sufficient size to determine effectiveness of our intervention.

Being tested
Zoledronic acid, normal saline 0.9%
Keywords
spinal cord injury, bone mineral density
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoledronic acidDrug

    Also called Reclast

    5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.

  • normal saline 0.9%Drug

    Also called normal saline, 0.9% saline

    Infusion of equivalent volume of 0.9% normal saline to that of the reconstituted zoledronic acid, given only once over two hours, occurring within 21 days of acute traumatic spinal cord injury

Study groups in NCT01642901
Study groupRoleWhat they receive
Zoledronic Acid 5 mg IV infusionExperimentalSingle infusion of 5 mg intravenous zoledronic acid given within 21 days of acute traumatic spinal cord injury.
Receives: Drug: Zoledronic acid
normal saline 0.9%Placebo comparatorInfusion of normal saline of equivalent volume to reconstituted zoledronic acid, given only once and run over 2 hours, to occur within 21 days of acute traumatic spinal cord injury.
Receives: Drug: normal saline 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Areal Bone Mineral Density at Hip

    Percent change in areal bone mineral density (aBMD) assessed by dual energy X-ray absorptiometry (DXA) at 4 months compared to baseline.

    This will compare aBMD at the hip.

    Measured: 4 months

  2. Change in Areal Bone Mineral Density at Knee

    Percent change in areal bone mineral density (aBMD) assessed by dual energy X-ray absorptiometry (DXA) at 4 months compared to baseline.

    This will compare aBMD at the distal femur and proximal tibia.

    Measured: 4 months

  3. Change in Areal Bone Mineral Density at Hip

    Percent change in areal bone mineral density (aBMD) assessed by dual energy X-ray absorptiometry (DXA) at 12 months post-injury compared to baseline.

    This will compare aBMD at the hip.

    Measured: one year

  4. Change in Areal Bone Mineral Density at Knee

    Percent change in areal bone mineral density (aBMD) assessed by dual energy X-ray absorptiometry (DXA) at 12 months post-injury compared to baseline.

    This will compare aBMD at the distal femur and proximal tibia.

    Measured: one year

Secondary outcomes (3)

  1. Change in Biomarkers of Bone Resorption (sCTX)

    Change in sCTX from baseline to 1- and 4-months post intervention and 12-months post-injury.

    Measured: 1 month, 4 months, 12 months

  2. Change in Biomarkers of Bone Formation (P1NP)

    Change in serum P1NP from baseline to 1- and 4-months post intervention.

    Measured: 1 month, 4 months

  3. Safety and Tolerability of Zoledronic Acid

    Assessment of the safety and tolerability of zoledronic acid in the acute spinal cord injury population. This will be done by examination reportable adverse events including fevers, flu-like symptoms, GI upset as measures of safety and report of patient's willingness to have participate in physical therapy in the first week after receiving medication as a measure of tolerability

    Measured: 72-hours and 1 month post intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642901
Sponsor's protocol ID
11F.612
Status last verified
May 2023
First submitted
6 Jul 2012
Last updated
23 May 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Oleson CV, Marino RJ, Formal CS, Modlesky CM, Leiby BE. The effect of zoledronic acid on attenuation of bone loss at the hip and knee following acute traumatic spinal cord injury: a randomized-controlled study. Spinal Cord. 2020 Aug;58(8):921-929. doi: 10.1038/s41393-020-0431-9. Epub 2020 Feb 13.

    PubMed 32055041

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zoledronic acid and normal saline 0.9% in people with Spinal Cord Injury, run by Thomas Jefferson University 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 21 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: finished, as of the sponsor's last update on 23 May 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 May 2023). 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?

Change in Areal Bone Mineral Density at Hip (time frame: 4 months). 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?

On the ClinicalTrials.gov record for NCT01642901, 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 23 May 2023.

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