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.