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Romosozumab for Osteoporosis in Women with Spinal Cord Injury
Study Summary
This trial will test whether a monthly injection of romosozumab can stop or reverse bone loss in women with chronic spinal cord injury and osteoporosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 245 Patients • NCT02186171Trial Design
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- Your vitamin D levels should be at least 20 ng/ml. If they are lower, you may need to take vitamin D and get retested before the study starts.I cannot walk or have severe difficulty walking.I had a spinal cord injury more than 6 months ago.I do not have diabetes or untreated thyroid conditions.I can sit upright and take pills for at least 30 minutes.I have a history of stroke or heart disease, but not high blood pressure.I have bone growth in my knee that affects CT scans.I can attend all required study visits.I am taking medication for seizures that may affect my bone health.I am currently taking glucocorticoid medication, not including inhalers.I have or am at risk for jawbone damage due to dental issues or procedures.I haven't used any bone-strengthening drugs in the last 5 years.I am female.I am allergic to romosozumab or alendronate.I have a neurological condition that affects my ability to walk or move my muscles.Your blood calcium levels are within the normal range according to local lab standards.My kidneys are not working well (low creatinine clearance).I have osteoporosis, confirmed by a DXA scan.I am at a higher risk of choking on food or liquids.I have Paget's disease of the bone.I have a condition that slows down my esophagus from emptying.I am 18 years old or older.I have had cancer spread to my bones.Your thyroid hormone levels are within the normal range according to local lab standards.I am using or willing to use birth control or practice abstinence during and up to 3 months after the study.I have a digestive condition that affects how my body absorbs nutrients.
- Group 1: Females with Chronic SCI
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is the recruitment period for this clinical experiment still ongoing?
"According to clinicaltrials.gov, this research trial is presently looking for volunteers with the first posting on March 1st 2021 and most recent update occurring April 1st 2022."
What risks might individuals incur when using Romosozumab?
"Our team at Power rated the safety of Romosozumab as a 2; while there is evidence to support its security, no data exists corroborating its efficacy."
What is the uppermost limit for patient participation in this trial?
"Affirmative. As evidenced by the clinicaltrials.gov website, this medical experiment is still in progress and seeking out volunteers; it was first made public on March 1st 2021, with its most recent edit taking place on April 1st 2022. The study requires 12 participants from a single site to participate."
Has Romosozumab been explored in previous clinical studies?
"As of today, there are 22 studies in action related to Romosozumab with 3 at the Phase 3 level. While a majority of these research initiatives take place within Douliu, Yunlin County, 73 distinct locations have scientific investigations underway involving this biologic therapy."
In what clinical scenarios is Romosozumab typically administered?
"Romosozumab is a viable therapeutic option for individuals with major health issues like osteogenesis imperfecta (oi), as well as postmenopause, paget’s disease and osteoporosis."
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