NCT02325414

Prevention of Bone Loss After Acute SCI by Zoledronic Acid

Prevention of Bone Loss After Acute SCI by Zoledronic Acid: Durability, Effect on Bone Strength, and Use of Biomarkers to Guide Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to define an effective therapeutic approach, using currently available medication, to prevent or mitigate the loss of bone mass and bone strength that occurs after acute spinal cord injury.

Detailed description

This is a randomized, double-blind placebo-controlled study of zoledronic acid to evaluate its efficacy and safety over a 2 year period for the prevention of bone loss and maintenance of bone strength in individuals with recent onset SCI (see diagram below). Subjects will be randomized at the baseline visit to receive either zoledronic acid or placebo. At the end of the first year of the study, each treatment group will be re-randomized to either zoledronic acid or placebo to evaluate the durability of response to zoledronic acid and the utility of serum bone markers to guide therapeutic decision making. DXA imaging, CT imaging and bone markers will be obtained at baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

Conditions

• Spinal Cord Injury
• Acute Spinal Cord Injury
• Bone Loss
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Zoledronic acid	Intravenous infusion of zoledronic acid 5 mg.
DRUG	Placebo	Placebo (saline) infusion to match zoledronic acid

Timeline

• Start date: 2015-02-01
• Primary completion: 2020-08-25
• Completion: 2020-08-25
• First posted: 2014-12-25
• Last updated: 2025-12-02
• Results posted: 2021-06-02

Locations

2 sites across 1 country: United States