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Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

NCT04597931 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-22

No results posted yet for this study

Summary

This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

Conditions

  • Osteoporosis Fracture
  • Spinal Cord Injuries

Interventions

DRUG

Romosozumab

SC Romosozumab 210 mg/monthly

DRUG

Zoledronic Acid

IV Zoledronic acid 5 mg

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Liana Tripto-Shkolnik, MD · Sheba Medical Center, Tel Hashomer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-11-15
Completion
2023-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597931 on ClinicalTrials.gov