Prevention of Bone Loss After Acute SCI by Zoledronic Acid (NCT02325414) | Clinical Trial Compass
CompletedPhase 2
Prevention of Bone Loss After Acute SCI by Zoledronic Acid
United States60 participantsStarted 2015-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
What they're measuring
1
Percent Change in Bone Mass Density (BMD) in the Hip
Timeframe: 0-12 months
2
Percent Change of Bone Mass Density (BMD) in the Femoral Neck