Phase 2
N=60
Prevention of Bone Loss After Acute SCI by Zoledronic Acid
Spinal Cord Injury · Acute Spinal Cord Injury · Bone Loss · Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT02325414 ↗Enrolled (actual)
60
Serious AEs
28.3%
Results posted
Jun 2021
Primary outcome: Primary: Percent Change in Bone Mass Density (BMD) in the Hip — -2.21; -12.82 percent change in bone mass density — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zoledronic acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Bone Mass Density (BMD) in the Hip |
-2.21; -12.82 | 0.05 |
| PRIMARY Percent Change of Bone Mass Density (BMD) in the Femoral Neck |
-1.72; -11.34 | — |
| SECONDARY Percent Change in the Epiphyseal Integral Bone Mass Content (iBMC) of the Femur |
-9.6; -22.90 | — |
| SECONDARY Percent Change in the Metaphyseal Integral Bone Mass Content (iBMC) of the Femur |
-4.73; -8.88 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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 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
Data sourced from ClinicalTrials.gov (NCT02325414). 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.