Bone Loss
Conditions
Keywords
spinal cord injury, osteoporosis, bone loss, zoledronic acid, bisphosphonate
Brief summary
This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.
Interventions
DRUGzoledronic acid
zoledronic acid, 5mg, iv
DRUGplacebo
iv
Sponsors
Novartis
Thomas J. Schnitzer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women 2. Age 18 years and older 3. Spinal cord injury within 8 weeks of study entry 4. ASIA AIS A or B 5. Medically stable in the opinion of their physiatrist 6. Able to have dexa performed 7. Able to return for follow-up at 6 and 12 months
Exclusion criteria
1. Vitamin D deficiency 2. Hypocalcemia 3. Renal insufficiency (estimated creatinine clearance \<30ml/min) 4. Abnormal thyroid hormone status 5. Abnormal mental status 6. Osteoporosis at the hip or spine by dexa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mass Density (BMD) at Total Hip | 6 months | bone mineral density measured by DXA at the total hip |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMD at Other Skeletal Sites | 6 months | BMD at spine, femoral neck, distal femur, proximal tibia, heel |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoledronic Acid zoledronic acid: zoledronic acid, 5mg, iv | 8 |
| Placebo placebo: iv | 9 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Zoledronic Acid | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 16.3 | 34.1 years STANDARD_DEVIATION 15.5 | 38.9 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 6 / 8 | 6 / 9 |
| serious Total, serious adverse events | 1 / 8 | 3 / 9 |
Outcome results
Primary
Bone Mass Density (BMD) at Total Hip
bone mineral density measured by DXA at the total hip
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoledronic Acid | Bone Mass Density (BMD) at Total Hip | -3.7 %change in BMD from baseline | Standard Deviation 1 |
| Placebo | Bone Mass Density (BMD) at Total Hip | -12.3 %change in BMD from baseline | Standard Deviation 6.9 |
p-value: 0.03t-test, 2 sided
Secondary
BMD at Other Skeletal Sites
BMD at spine, femoral neck, distal femur, proximal tibia, heel
Time frame: 6 months
Population: heel measurements were not performed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid | BMD at Other Skeletal Sites | spine BMD | 2.4 percentage of baseline BMD | Standard Deviation 1.8 |
| Zoledronic Acid | BMD at Other Skeletal Sites | right femoral neck BMD | -2.2 percentage of baseline BMD | Standard Deviation 3.4 |
| Zoledronic Acid | BMD at Other Skeletal Sites | distal femur | -8.2 percentage of baseline BMD | Standard Deviation 7.7 |
| Zoledronic Acid | BMD at Other Skeletal Sites | proximal tibia | -3.3 percentage of baseline BMD | Standard Deviation 2.9 |
| Placebo | BMD at Other Skeletal Sites | proximal tibia | -13.8 percentage of baseline BMD | Standard Deviation 10.5 |
| Placebo | BMD at Other Skeletal Sites | spine BMD | -2.5 percentage of baseline BMD | Standard Deviation 2.2 |
| Placebo | BMD at Other Skeletal Sites | distal femur | -9.1 percentage of baseline BMD | Standard Deviation 7.1 |
| Placebo | BMD at Other Skeletal Sites | right femoral neck BMD | -8.6 percentage of baseline BMD | Standard Deviation 33333.5 |