Overview

Zoledronic Acid Administration in Acute Spinal Cord Injury

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Collaborator:
Kessler Institute for Rehabilitation
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
Inclusion Criteria:

1. Within 3 months of the date of acute SCI.

2. Motor-complete and incomplete SCI [American Spinal Injury Association Impairment Scale
(AIS) of sensorimotor impairment (AIS A, B, and C)]

Exclusion Criteria:

1. Extensive life-threatening injuries (in addition to SCI)

2. Femur or tibia fracture or extensive bone trauma

3. History of prior bone disease (Paget's disease, overactive parathyroid, osteoporosis)

4. Post-menopausal women

5. Known allergy to bisphosphonates

6. Severe underlying chronic illness

7. Current diagnosis of cancer or history of cancer

8. I am currently receiving corticosteroids

9. Pregnancy or lactation

10. I have been diagnosed with kidney problems

11. As determined from the prescreening blood tests by the study physician Serum
creatinine > 2.0 mg/dl

12. As determined from the prescreening blood tests by the study physician Corrected
calcium < 8 mg/dl or > 11 mg/dl

13. As determined from the prescreening blood tests by the study physician Elevated liver
function enzymes > 2 x upper limit of normal (ULN)

14. I am taking a bisphosphonate for heterotopic ossification (HO) (an overgrowth of bone
typically diagnosed shortly after SCI in the pelvic region)

15. I have an existing dental condition or dental infection.