Phase 4
N=21
Zoledronic Acid Administration in Acute Spinal Cord Injury
Disuse Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT02042872 ↗Enrolled (actual)
21
Serious AEs
19.1%
Results posted
Jul 2014
Primary outcome: Primary: Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12. — 1.102; 1.134; 0.898; 1.038 g/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zoledronic acid (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- James J. Peters Veterans Affairs Medical Center
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12. |
1.102; 1.134; 0.898; 1.038; 1.274; 1.341 | — |
| SECONDARY Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12 |
1.125; 1.020; 1.042; 0.814 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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)]
Exclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT02042872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.