The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    32
  • sponsor
    James J. Peters Veterans Affairs Medical Center
Updated on 27 February 2022
cancer
spinal cord
spinal cord disorder
spinal injury

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.

Description

The primary objective of this study is to test the efficacy of a potent anti-resorptive agent, denosumab [receptor activator of nuclear factor-B ligand (RANKL) antibody; Amgen Inc.] to preserve bone mass at the hip and knee and trabecular connectivity at the knee after subacute motor-incomplete SCI [American Spinal Injury Association (AIS) neurological classification scale C and D] at the James J. Peters VA Medical Center (JJPVAMC) and Kessler Institute for Rehabilitation (KIR). A randomized, double-blind, placebo-controlled, parallel group trial will be performed in thirty-two subjects with acute, motor-incomplete SCI (6 months) who have been admitted to JJPVAMC or the KIR. Denosumab (60 mg SC) will be administered at baseline, 6, and 12 months; the placebo group will receive normal saline subcutaneously. Denosumab will be administered as soon as possible, but up to 24 weeks, after SCI. The last dose of denosumab and placebo will be administered at 6 months, with the anticipated effect of the drug to persist and inhibit bone resorption at least until the 12 month time point.

Details
Condition Secondary Osteoporosis, Spinal Cord Injury
Treatment Placebo (Normal Saline), Denosumab (Prolia)
Clinical Study IdentifierNCT03029442
SponsorJames J. Peters Veterans Affairs Medical Center
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Motor incomplete SCI [American Spinal Injury Association Impairment Scale (AIS) grades C and D]
Duration of injury < 6-months; and
Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old

Exclusion Criteria

Extensive life-threatening injuries in addition to SCI
Acute fracture or extensive bone trauma
History of prior bone disease (Paget's hyperparathyroidism, osteoporosis, etc.)
Post-menopausal women
Men with known hypogonadism prior to SCI
Anabolic or Steroid hormonal therapy; within the past year and longer than six months
Hyperthyroidism
Cushing's disease or syndrome
Severe underlying chronic disease
History of chronic alcohol abuse
Diagnosis of Hypocalcemia
Pregnancy
Existing dental condition/dental infection
Diagnosis of heterotopic ossification at the hip and/or knee region and receiving a bisphosphonates [e.g. alendronate sodium (Fosamax) or etidronate disodium (Didronel)] that will no longer make participants eligible to receive the study medication/placebo but are still eligible to complete follow-up outcome measures as described in the work schedule
Current diagnosis of cancer or history of cancer; and
Any patient receiving moderate or high dose corticosteroids (>40 mg/d prednisone or an equivalent dose of other corticosteroid) for longer than one week, not including drug administered in an attempt to preserve neurological function at the time of acute SCI
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