Spinal Cord Injury | Zoledronic Acid in Acute Spinal Cord Injury
Spinal Cord Injury research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Ages 18-65, male or female - Traumatic SCI with Neurological level C4-T10, AIS (ASIA Impairment Scale) A, - Serum calcium level >7.0 mg/dL) at time of study drug administration - Screening baseline serum 25OH (25-hydroxy) 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 DXA scanner Exclusion Criteria: - 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 - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Spinal Cord Injury
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Zoledronic acid5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.
Drug:normal saline 0.9%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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Zoledronic Acid 5 mg IV infusionSingle infusion of 5 mg intravenous zoledronic acid given within 21 days of acute traumatic spinal cord injury.
normal saline 0.9%Infusion 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.
Active, not recruiting
Start Date: May 2012
Completed Date: June 2018
Phase: Phase 3
Primary Outcome: change in bone mineral density
Secondary Outcome: Biomarkers of bone formation and resorption
Study sponsors, principal investigator, and references
Principal Investigator: Christina V Oleson, MD
Lead Sponsor: Thomas Jefferson University
Collaborator: Department of Health and Human Services