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Your journey
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More info
You can access this
clinical trial
if you have
Secondary Osteoporosis or Spinal Cord Injury
and you are
between 18 and 65
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

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.

Provided treatments

  • Drug: Denosumab (Prolia)
  • Other: Placebo (normal saline)
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Locations near you

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Tris trial is registered with FDA with number: NCT03029442. The sponsor of the trial is James J. Peters Veterans Affairs Medical Center and it is looking for 32 volunteers for the current phase.
Official trial title:
The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury