Zoledronic Acid Administration in Acute Spinal Cord Injury
The Efficacy of Zoledronic Acid in the Prevention of Bone Loss in Acute Spinal Cord Injury
2 other identifiers
interventional
21
1 country
1
Brief Summary
In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on preservation of regional and total skeletal mass (DXA). Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI, as evidenced by serial densitometry determinations (DXA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedResults Posted
Study results publicly available
July 28, 2014
CompletedMarch 14, 2018
March 1, 2018
6.2 years
January 21, 2014
March 12, 2014
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.
An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the distal femur and proximal tibia by using a customized research software program supplied by the manufacturer. This measurement will be the primary determinant (dependent measure) of difference among the treatment and control groups, and they will be followed over time at the previously specified time points.
Baseline and 12 months
Secondary Outcomes (1)
Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12
Baseline and 12 months
Study Arms (2)
Zoledronic acid
EXPERIMENTALAt baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
No Intervention
NO INTERVENTIONParticipants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
Interventions
At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
Eligibility Criteria
You may qualify if:
- Within 3 months of the date of acute SCI.
- Motor-complete and incomplete SCI \[American Spinal Injury Association Impairment Scale (AIS) of sensorimotor impairment (AIS A, B, and C)\]
You may not qualify if:
- Extensive life-threatening injuries (in addition to SCI)
- Femur or tibia fracture or extensive bone trauma
- History of prior bone disease (Paget's disease, overactive parathyroid, osteoporosis)
- Post-menopausal women
- Known allergy to bisphosphonates
- Severe underlying chronic illness
- Current diagnosis of cancer or history of cancer
- I am currently receiving corticosteroids
- Pregnancy or lactation
- I have been diagnosed with kidney problems
- As determined from the prescreening blood tests by the study physician Serum creatinine \> 2.0 mg/dl
- As determined from the prescreening blood tests by the study physician Corrected calcium \< 8 mg/dl or \> 11 mg/dl
- As determined from the prescreening blood tests by the study physician Elevated liver function enzymes \> 2 x upper limit of normal (ULN)
- I am taking a bisphosphonate for heterotopic ossification (HO) (an overgrowth of bone typically diagnosed shortly after SCI in the pelvic region)
- I have an existing dental condition or dental infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052, United States
Related Publications (2)
Shapiro J, Smith B, Beck T, Ballard P, Dapthary M, BrintzenhofeSzoc K, Caminis J. Treatment with zoledronic acid ameliorates negative geometric changes in the proximal femur following acute spinal cord injury. Calcif Tissue Int. 2007 May;80(5):316-22. doi: 10.1007/s00223-007-9012-6. Epub 2007 Apr 7.
PMID: 17417700BACKGROUNDBubbear JS, Gall A, Middleton FR, Ferguson-Pell M, Swaminathan R, Keen RW. Early treatment with zoledronic acid prevents bone loss at the hip following acute spinal cord injury. Osteoporos Int. 2011 Jan;22(1):271-9. doi: 10.1007/s00198-010-1221-6. Epub 2010 Apr 1.
PMID: 20358358BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The clinical trial was not randomized, it had a relatively small sample size, and 5 participants received high-dose corticosteroids in an attempt to preserve neurologic function upon that could have had a profound adverse effect on the skeleton.
Results Point of Contact
- Title
- William A. Bauman, M.D.
- Organization
- James J. Peters VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
William A Bauman, M.D.
James J. Peters VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director VA RR&D Center of Excellence for the Medical Consequences of SCI
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 23, 2014
Study Start
May 1, 2006
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
March 14, 2018
Results First Posted
July 28, 2014
Record last verified: 2018-03