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

NCT02325414 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Northwestern University
Phase	Phase 2
Status	COMPLETED
Enrolment	60
Start date	2015-02
Completion	2020-08-25

Conditions

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

Interventions

• Zoledronic acid
• Placebo

Primary outcomes

• Percent Change in Bone Mass Density (BMD) in the Hip — 0-12 months
  Percent change of bone mass density (BMD) in the total hip (as measured by DXA)
• Percent Change of Bone Mass Density (BMD) in the Femoral Neck — 0-12 months
  Percent change of bone mass density (BMD) in the femoral neck (as measured by DXA)

Countries

United States