Zoledronic Acid Administration in Acute Spinal Cord Injury
Completed · Phase 4
Conditions studied: Disuse Osteoporosis
In brief
In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on preservation of regional and total skeletal mass (DXA). Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI, as evidenced by serial densitometry determinations (DXA).
Key facts
- Study ID
- NCT02042872
- Run by
- James J. Peters Veterans Affairs Medical Center
- People needed
- 21
- Starts
- 2006-05-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2018-03-14
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Within 3 months of the date of acute SCI.
- Motor-complete and incomplete SCI [American Spinal Injury Association Impairment Scale (AIS) of sensorimotor impairment (AIS A, B, and C)]
You may not qualify if…
- Extensive life-threatening injuries (in addition to SCI)
- Femur or tibia fracture or extensive bone trauma
- History of prior bone disease (Paget's disease, overactive parathyroid, osteoporosis)
- Post-menopausal women
- Known allergy to bisphosphonates
- Severe underlying chronic illness
- Current diagnosis of cancer or history of cancer
- I am currently receiving corticosteroids
- Pregnancy or lactation
- I have been diagnosed with kidney problems
- As determined from the prescreening blood tests by the study physician Serum creatinine > 2.0 mg/dl
- As determined from the prescreening blood tests by the study physician Corrected calcium < 8 mg/dl or > 11 mg/dl
- As determined from the prescreening blood tests by the study physician Elevated liver function enzymes > 2 x upper limit of normal (ULN)
- I am taking a bisphosphonate for heterotopic ossification (HO) (an overgrowth of bone typically diagnosed shortly after SCI in the pelvic region)
- I have an existing dental condition or dental infection.
Where it is running
- Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
Full record on ClinicalTrials.gov
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