Spinal injury patients may keep stronger bones with simple infusion
NCT ID NCT02325414
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a single dose of zoledronic acid, a drug already used for osteoporosis, can prevent the rapid bone loss that often follows a spinal cord injury. Researchers enrolled 60 adults who had recently lost the ability to walk due to injury. They measured changes in bone density and strength over time to see if the treatment helped preserve bone health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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60 people
The number who actually took part.
- Started
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Feb 2015
- Finished
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Aug 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \<2.0 mg/dl) * Well hydrated with adequate intake of liquids * Able to return for all follow-up visits * Capable of reading and understanding informed consent document * Males and females of childbearing potential must be willing and able to use double barrier method of contraception for 2 months after having received study drug Exclusion Criteria: * Have Paget's disease of the bone * Malignancy as a cause of acute SCI * Have unexplained high levels of alkaline phosphatase in blood * Any active gastrointestinal condition that results in malabsorption * Poor dental hygiene or requirement for invasive dental procedure within two months prior to enrollment * History of bone metastasis and skeletal malignancies * History of alcoholism or drug abuse within the 2 years prior to study screening * Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study * Elevated liver function tests \>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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
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Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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