MedTrace Logo

The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

NCT03029442 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-03-15

No results posted yet for this study

Summary

The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.

Conditions

  • Secondary Osteoporosis
  • Spinal Cord Injury

Interventions

DRUG

Denosumab (Prolia)

In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates. The dose of denosumab chosen for our protocol in patients after acute SCI will be the same dose that has been shown to be efficacious to treat postmenopausal osteoporosis (60 mg SQ q 6 months).

OTHER

Placebo (normal saline)

Identical Denosumab volume of normal saline

Sponsors & Collaborators

  • Kessler Institute for Rehabilitation

    collaborator INDUSTRY

  • James J. Peters Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • William A Bauman, M.D. · James J. Peters VA Medical Center

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2021-12-31
Completion
2022-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03029442 on ClinicalTrials.gov