Trial Outcomes & Findings for Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss (NCT NCT00844480)

NCT ID: NCT00844480

Last Updated: 2017-06-14

Results Overview

bone mineral density measured by DXA at the total hip

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Zoledronic Acid zoledronic acid: zoledronic acid, 5mg, iv	Placebo placebo: iv
Overall Study STARTED	8	9
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Zoledronic Acid zoledronic acid: zoledronic acid, 5mg, iv	Placebo placebo: iv
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

Baseline characteristics by cohort

Measure	Zoledronic Acid n=8 Participants zoledronic acid: zoledronic acid, 5mg, iv	Placebo n=9 Participants placebo: iv	Total n=17 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 16.3 • n=5 Participants	34.1 years STANDARD_DEVIATION 15.5 • n=7 Participants	38.9 years STANDARD_DEVIATION 16.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

bone mineral density measured by DXA at the total hip

Outcome measures

Measure	Zoledronic Acid n=6 Participants zoledronic acid: zoledronic acid, 5mg, iv	Placebo n=6 Participants placebo: iv
Bone Mass Density (BMD) at Total Hip	-3.7 %change in BMD from baseline Standard Deviation 1.0	-12.3 %change in BMD from baseline Standard Deviation 6.9

SECONDARY outcome

Timeframe: 6 months

Population: heel measurements were not performed

BMD at spine, femoral neck, distal femur, proximal tibia, heel

Outcome measures

Measure	Zoledronic Acid n=6 Participants zoledronic acid: zoledronic acid, 5mg, iv	Placebo n=6 Participants placebo: iv
BMD at Other Skeletal Sites right femoral neck BMD	-2.2 percentage of baseline BMD Standard Deviation 3.4	-8.6 percentage of baseline BMD Standard Deviation 33333.5
BMD at Other Skeletal Sites spine BMD	2.4 percentage of baseline BMD Standard Deviation 1.8	-2.5 percentage of baseline BMD Standard Deviation 2.2
BMD at Other Skeletal Sites distal femur	-8.2 percentage of baseline BMD Standard Deviation 7.7	-9.1 percentage of baseline BMD Standard Deviation 7.1
BMD at Other Skeletal Sites proximal tibia	-3.3 percentage of baseline BMD Standard Deviation 2.9	-13.8 percentage of baseline BMD Standard Deviation 10.5

Adverse Events

Zoledronic Acid

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zoledronic Acid n=8 participants at risk zoledronic acid: zoledronic acid, 5mg, iv	Placebo n=9 participants at risk placebo: iv
Nervous system disorders baclofen pump implant	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years
Skin and subcutaneous tissue disorders decubitus ulcer	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years
Infections and infestations infection	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years
Investigations hospitalization	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years

Other adverse events

Measure	Zoledronic Acid n=8 participants at risk zoledronic acid: zoledronic acid, 5mg, iv	Placebo n=9 participants at risk placebo: iv
Musculoskeletal and connective tissue disorders femoral fracture	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years
Infections and infestations urinary tract infection	12.5% 1/8 • Number of events 1 • 2 years	11.1% 1/9 • Number of events 3 • 2 years
General disorders fever	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 2 • 2 years
General disorders headache	12.5% 1/8 • Number of events 1 • 2 years	11.1% 1/9 • Number of events 2 • 2 years
Gastrointestinal disorders gasric ulcer	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years
Cardiac disorders hypertension	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years
Cardiac disorders chest pain	12.5% 1/8 • Number of events 1 • 2 years	11.1% 1/9 • Number of events 1 • 2 years
Gastrointestinal disorders abdominal pain	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years
Skin and subcutaneous tissue disorders pressure ulcer	12.5% 1/8 • Number of events 2 • 2 years	0.00% 0/9 • 2 years
Skin and subcutaneous tissue disorders ingrown hair	0.00% 0/8 • 2 years	11.1% 1/9 • Number of events 1 • 2 years
Renal and urinary disorders kidney stone	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years
Musculoskeletal and connective tissue disorders arthralgia	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years
Musculoskeletal and connective tissue disorders musculoskeletall pain	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years
Gastrointestinal disorders nausea	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years
Renal and urinary disorders hematuria	12.5% 1/8 • Number of events 1 • 2 years	0.00% 0/9 • 2 years

Additional Information

Thomas Schnitzer

Northwestern University

Phone: 312-503-2315

Email: tjs@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place