Phase 2 Completed N=60 Randomized Quadruple-blind Prevention

Prevention of Bone Loss After Acute SCI by Zoledronic Acid

Spinal Cord Injury · Bone loss · Osteoporosis

Source: ClinicalTrials.gov NCT02325414 ↗

Enrolled (actual)

Serious AEs

28.3%

Results posted

Jun 2021

Primary outcomePrimary: Percent Change in Bone Mass Density (BMD) in the Hip — -2.21; -12.82 percent change in bone mass density — p=0.05

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.

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	—

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

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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. Informational only — not medical advice.