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Spinal Cord InjuryPhase 2NCT02325414

Prevention of Bone Loss After Acute SCI by Zoledronic Acid

A Phase 2 study testing Zoledronic acid in people with Spinal Cord Injury and Acute Spinal Cord Injury, run by Northwestern University at 2 sites 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

The overall objective of this study is to define an effective therapeutic approach, using currently available medication, to prevent or mitigate the loss of bone mass and bone strength that occurs after acute spinal cord injury. Read more about this study

Who is it for?
Ages 18 years and older
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
60 participants
Where
2 sitesUnited States
Study dates
Feb 2015to 25 Aug 2020
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

  • In-patient at Rehabilitation Institute of Chicago (RIC) or an outpatient who was recently discharged from RIC
  • Males and females
  • Age >/=18 years
  • Medically stable in the opinion of subject's physiatrist
  • SCI at within 120 days inclusive at time of screening
  • SCI with inability to ambulate independently
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  • ASIA Impairment Scale (AIS) A, B, or C, at time of study entry
  • Capable of positioning to have DXA performed
  • Able to tolerate acetaminophen
  • No known endocrinopathies (diabetes type 1 or 2 can be included)
  • Normal TSH levels
  • Normal 25-OH vitamin D levels (>/= 20 ng/ml) at baseline (subjects may be repleted)
  • Normal calcium levels
  • Normal renal function (creatinine <2.0 mg/dl)
  • Well hydrated with adequate intake of liquids
  • Able to return for all follow-up visits
  • Capable of reading and understanding informed consent document
  • Males and females of childbearing potential must be willing and able to use double barrier method of contraception for 2 months after having received study drug

Who cannot join

  • Have Paget's disease of the bone
  • Malignancy as a cause of acute SCI
  • Have unexplained high levels of alkaline phosphatase in blood
  • Any active gastrointestinal condition that results in malabsorption
  • Poor dental hygiene or requirement for invasive dental procedure within two months prior to enrollment
  • History of bone metastasis and skeletal malignancies
Show all 13Show fewer
  • History of alcoholism or drug abuse within the 2 years prior to study screening
  • Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
  • Elevated liver function tests >2x normal
  • Currently being prescribed anti-convulsants at a dose or frequency that is determined to interfere with bone metabolism as determined by the investigator
  • Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
  • Current or recent use any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds within 60 days of screening.
  • Pregnant, planning to become pregnant, or lactating

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Rehabilitation Institute of Chicago

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Prevention of Bone Loss After Acute SCI by Zoledronic Acid: Durability, Effect on Bone Strength, and Use of Biomarkers to Guide Therapy

The overall objective of this study is to define an effective therapeutic approach, using currently available medication, to prevent or mitigate the loss of bone mass and bone strength that occurs after acute spinal cord injury.

Read the detailed description

This is a randomized, double-blind placebo-controlled study of zoledronic acid to evaluate its efficacy and safety over a 2 year period for the prevention of bone loss and maintenance of bone strength in individuals with recent onset SCI (see diagram below). Subjects will be randomized at the baseline visit to receive either zoledronic acid or placebo. At the end of the first year of the study, each treatment group will be re-randomized to either zoledronic acid or placebo to evaluate the durability of response to zoledronic acid and the utility of serum bone markers to guide therapeutic decision making. DXA imaging, CT imaging and bone markers will be obtained at baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

Being tested
Zoledronic acid, Placebo
Keywords
Osteoporosis, Spinal Cord Injury, Bone Diseases, Metabolic Bone Diseases, Musculoskeletal Diseases, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Nervous System, Wounds and Injuries, Bone Density Conservation Agents, Physiological Effects of Drugs, Pharmacologic Actions, Department of Defense
Medical subject headings
Spinal Cord Injuries, Bone Diseases, Metabolic, Osteoporosis, Bone Diseases, Musculoskeletal Diseases, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases

What participants receive

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

  • Zoledronic acidDrug

    Also called Reclast, Zometa, Bisphosphonate

    Intravenous infusion of zoledronic acid 5 mg.

  • PlaceboDrug

    Also called Saline

    Placebo (saline) infusion to match zoledronic acid

Study groups in NCT02325414
Study groupRoleWhat they receive
ZolExperimentalIntravenous infusion of zoledronic acid (zol) 5 mg at baseline.
Receives: Drug: Zoledronic acid
PlaceboExperimentalIntravenous infusion of placebo at baseline.
Receives: Drug: Placebo

What is being measured

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

  1. Percent Change in Bone Mass Density (BMD) in the Hip

    Percent change of bone mass density (BMD) in the total hip (as measured by DXA)

    Measured: 0-12 months

  2. Percent Change of Bone Mass Density (BMD) in the Femoral Neck

    Percent change of bone mass density (BMD) in the femoral neck (as measured by DXA)

    Measured: 0-12 months

Secondary outcomes (2)

  1. Percent Change in the Epiphyseal Integral Bone Mass Content (iBMC) of the Femur

    Percent change in the epiphyseal integral bone mass content (iBMC) of the femur, as collected by CT.

    Measured: 0-12 months

  2. Percent Change in the Metaphyseal Integral Bone Mass Content (iBMC) of the Femur

    Percent change in the metaphyseal integral bone mass content (iBMC) of the femur, as collected by CT

    Measured: 0-12 months

Timeline

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

  1. First posted25 Dec 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completion25 Aug 2020
  4. Study completion25 Aug 2020

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02325414
Sponsor's protocol ID
STU00098239
Other IDs
CDMRP-130125
Status last verified
Nov 2025
First submitted
21 Dec 2014
Last updated
2 Dec 2025
Data monitoring committee
Yes

Publications

  • Edwards WB, Haider IT, Simonian N, Barroso J, Schnitzer TJ. Durability and delayed treatment effects of zoledronic acid on bone loss after spinal cord injury: a randomized, controlled trial. J Bone Miner Res. 2021 Nov;36(11):2127-2138. doi: 10.1002/jbmr.4416. Epub 2021 Jul 29.

    PubMed 34278611

  • Haider IT, Lobos SM, Simonian N, Schnitzer TJ, Edwards WB. Bone fragility after spinal cord injury: reductions in stiffness and bone mineral at the distal femur and proximal tibia as a function of time. Osteoporos Int. 2018 Dec;29(12):2703-2715. doi: 10.1007/s00198-018-4733-0. Epub 2018 Oct 17.

    PubMed 30334093

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zoledronic acid in people with Spinal Cord Injury and Acute Spinal Cord Injury, run by Northwestern University at 2 sites 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 18 inclusion and 13 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 2 Jun 2021). 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?

Percent Change in Bone Mass Density (BMD) in the Hip (time frame: 0-12 months). 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?

On the ClinicalTrials.gov record for NCT02325414, which also lists 2 linked publications.

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 2 Dec 2025.

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