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Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

NCT05101018 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-17

No results posted yet for this study

Summary

The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.

Conditions

Interventions

DRUG

Romosozumab

Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month

DRUG

Denosumab

Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months

Sponsors & Collaborators

  • Kessler Institute for Rehabilitation

    collaborator INDUSTRY

  • James J. Peters Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Steven C Kirshblum, M.D. · Kessler Institute for Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2026-06-01
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05101018 on ClinicalTrials.gov