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Romosozumab in Women With Chronic SCI

NCT04708886 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-24

Study results available
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Summary

This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.

Conditions

  • Osteoporosis
  • Bone Loss
  • Osteopenia, Osteoporosis
  • Spinal Cord Injuries
  • Chronic Spinal Paralysis

Interventions

DRUG

Romosozumab

Year 1 study drug

DRUG

Alendronate

Year 2 study drug

Sponsors & Collaborators

Principal Investigators

  • Thomas J Schnitzer, MD, PhD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-06-10
Completion
2024-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04708886 on ClinicalTrials.gov