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Denosumab for Spinal Cord Injury
Study Summary
This trial is testing whether Denosumab can help prevent bone loss in legs due to SCI. The study will last for 12 months, with 6 visits ranging from 1-4.5 hours. The trial is double-blinded, meaning participants will be randomly assigned to Denosumab or placebo injections, not knowing which they are receiving.
- Osteoporosis
- Spinal Cord Injury
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 3 trial • 90 Patients • NCT01377467Trial Design
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- You have a serious long-term health condition.Women who have already gone through menopause.You are taking a high amount of corticosteroids for more than a week.You have partial paralysis from a spinal cord injury.Women aged 18 to 50 years old.You have very serious injuries in addition to spinal cord injury that could be life-threatening.You have recently broken a bone or have had severe bone injury.You have had bone diseases like Paget's, hyperparathyroidism, or osteoporosis in the past.You have a history of drinking alcohol excessively for a long time.You have a dental problem or infection.Your injury happened less than 6 months ago.Men who are between 18 and 65 years old.Men with a known condition of low testosterone levels before spinal cord injury.You have been diagnosed with low levels of calcium in your blood.You have been diagnosed with abnormal bone growth in the hip or knee area and are taking certain medications for it.You currently have cancer or have had cancer in the past.You have taken anabolic or steroid hormonal therapy in the past year for more than six months.You have overactive thyroid.You have Cushing's disease or syndrome.
- Group 1: Placebo, AIS Grade D (ambulatory)
- Group 2: Denosumab, AIS Grade C (non-ambulatory)
- Group 3: Placebo, AIS Grade C (non-ambulatory)
- Group 4: Denosumab, AIS Grade D (ambulatory)
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Denosumab (Prolia) for medical use?
"Data from clinical trials marking this medication's approval place the safety of Denosumab (Prolia) at a 3 on our team's rating scale."
What are the eligibility criteria for participating in this experiment?
"This clinical trial requires 32 individuals suffering from SCI between 18 and 65 years old. Notably, participants must have an AIS of C or D, their injury should be less than 6 months old, males must be aged 18-65 while females need to be under 50 years old."
Are there any other research projects that have explored the effects of Denosumab (Prolia)?
"Denosumab (Prolia) was initially trialled in 2016 at Xavier Nogues. To date, the drug has been studied 115 times, with 47 active trials occurring primarily out of Bronx, New york."
How many participants are anticipated for this medical experiment?
"Affirmative. Information from clinicaltrials.gov specifies that this research endeavour is currently enrolling participants; it was posted on April 1st 2017, and has most recently been updated on March 6th 2019. A total of 32 patients need to be enrolled at 2 distinct medical centres."
Are there any vacancies available to participate in this clinical trial?
"Per the details found on clinicaltrials.gov, this research trial is open for enrollment and was initially launched on April 1st 2017 before being updated lastly on March 6th 2019."
Is the participant demographic of this trial limited to adults aged 25 and over?
"This trial is seeking participants aged 18-65. Those younger than the age of consent can look into the 157 trials catered to their demographic, while those over 65 are encouraged to review the 887 clinical studies available for them."
What therapeutic conditions is Denosumab (Prolia) employed in?
"The drug denosumab (Prolia) is frequently utilized to treat bone-related issues, as well as skeletally mature individuals and certain malignant neoplasms."
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