Phase 3
N=15
Zoledronic Acid in Acute Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01642901 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
May 2023
Primary outcome: Primary: Change in Areal Bone Mineral Density at Hip — 0.92; -12.0; 1.19; -12.9 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic acid (Drug); normal saline 0.9% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Areal Bone Mineral Density at Hip |
-8.2; -21.3; -8.62; -19.4; -3.93; -17.0 | — |
| PRIMARY Change in Areal Bone Mineral Density at Knee |
-8.07; -10.0; -4.54; -10.0 | — |
| PRIMARY Change in Areal Bone Mineral Density at Hip |
-8.2; -21.3; -8.62; -19.4; -3.93; -17.0 | — |
| PRIMARY Change in Areal Bone Mineral Density at Knee |
-8.07; -10.0; -4.54; -10.0 | — |
| SECONDARY Change in Biomarkers of Bone Resorption (sCTX) |
-64.1; 14.4; -45.9; 23.9; -43.6; -5.11 | — |
| SECONDARY Change in Biomarkers of Bone Formation (P1NP) |
5.66; 65.96; 32.43; 27.45 | — |
| SECONDARY Safety and Tolerability of Zoledronic Acid |
7; 1; 6; 1; 1; 1 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 ( 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 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
Data sourced from ClinicalTrials.gov (NCT01642901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.