Trial Outcomes & Findings for Zoledronic Acid Administration in Acute Spinal Cord Injury (NCT NCT02042872)
NCT ID: NCT02042872
Last Updated: 2018-03-14
Results Overview
An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the distal femur and proximal tibia by using a customized research software program supplied by the manufacturer. This measurement will be the primary determinant (dependent measure) of difference among the treatment and control groups, and they will be followed over time at the previously specified time points.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2018-03-14
Participant Flow
Participant milestones
| Measure |
Zoledronic Acid
At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
|
No Treatment
Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
13
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zoledronic Acid Administration in Acute Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Zoledronic Acid
n=8 Participants
At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
|
No Treatment
n=13 Participants
Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 20.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsAn imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the distal femur and proximal tibia by using a customized research software program supplied by the manufacturer. This measurement will be the primary determinant (dependent measure) of difference among the treatment and control groups, and they will be followed over time at the previously specified time points.
Outcome measures
| Measure |
Zoledronic Acid
n=8 Participants
At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
|
No Treatment
n=13 Participants
Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
|
|---|---|---|
|
Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.
12 Month Proximal Tibia
|
1.022 g/cm2
Standard Deviation 0.267
|
1.237 g/cm2
Standard Deviation 0.276
|
|
Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.
Baseline Distal Femur
|
1.102 g/cm2
Standard Deviation 0.148
|
1.134 g/cm2
Standard Deviation 0.244
|
|
Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.
12 Month Distal Femur
|
0.898 g/cm2
Standard Deviation 0.128
|
1.038 g/cm2
Standard Deviation 0.241
|
|
Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.
Baseline Proximal Tibia
|
1.274 g/cm2
Standard Deviation 0.245
|
1.341 g/cm2
Standard Deviation 1.216
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsAn imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the total hip.
Outcome measures
| Measure |
Zoledronic Acid
n=8 Participants
At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
|
No Treatment
n=13 Participants
Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
|
|---|---|---|
|
Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12
Baseline Total Hip
|
1.125 g/cm2
Standard Deviation 0.166
|
1.020 g/cm2
Standard Deviation 0.154
|
|
Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12
12 Month Total Hip
|
1.042 g/cm2
Standard Deviation 0.168
|
0.814 g/cm2
Standard Deviation 0.151
|
Adverse Events
Zoledronic Acid
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
No Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zoledronic Acid
n=8 participants at risk
At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
|
No Treatment
n=13 participants at risk
Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
|
|---|---|---|
|
Surgical and medical procedures
General Surgery
|
37.5%
3/8 • Number of events 3 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
7.7%
1/13 • Number of events 1 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Gastrointestinal disorders
Bowel Impaction
|
12.5%
1/8 • Number of events 1 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
12.5%
1/8 • Number of events 1 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/8 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
7.7%
1/13 • Number of events 1 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Nervous system disorders
Spinal headache
|
12.5%
1/8 • Number of events 1 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Blood and lymphatic system disorders
Deep Venous Thrombosis
|
12.5%
1/8 • Number of events 1 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
7.7%
1/13 • Number of events 1 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
Other adverse events
| Measure |
Zoledronic Acid
n=8 participants at risk
At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
|
No Treatment
n=13 participants at risk
Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
|
|---|---|---|
|
General disorders
Acute Febrile Reaction
|
75.0%
6/8 • Number of events 8 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
8/8 • Number of events 8 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
6/8 • Number of events 8 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
General disorders
Lethargy
|
100.0%
8/8 • Number of events 8 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 8 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
0.00%
0/13 • 24 months
Monthly assessment of medical history over the 24 month follow-up period after baseline assessment.
|
Additional Information
William A. Bauman, M.D.
James J. Peters VA Medical Center
Phone: 718-584-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place