Your session is about to expire
← Back to Search
Monoclonal Antibodies
Romosozumab for Osteoporosis in Women with Spinal Cord Injury
Phase 2
Waitlist Available
Led By Thomas J Schnitzer, MD, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-ambulatory status (Walking Index for Spinal Cord Injury II score of 3 or less)
Able and willing to complete all the study visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 12 months
Awards & highlights
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.
Who is the study for?
This trial is for women over 18 with chronic spinal cord injury and osteoporosis, who've been non-ambulatory for at least 6 months. They must be in good health, have normal vitamin D and thyroid levels, not be pregnant or breastfeeding, able to take oral meds properly, and willing to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests romosozumab's effectiveness on bone loss in the first year through monthly injections followed by a second year taking alendronate tablets weekly. It aims to see how well these treatments improve bone density in women with SCI-related osteoporosis.See study design
What are the potential side effects?
Potential side effects include joint pain, headache, injection site reactions (like redness or swelling), possible increased risk of heart attack or stroke with romosozumab. Alendronate may cause digestive issues like heartburn or ulcers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot walk or have severe difficulty walking.
Select...
I can attend all required study visits.
Select...
I am female.
Select...
I have osteoporosis, confirmed by a DXA scan.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline - 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in knee integral vBMC
Secondary outcome measures
Change in hip BMD
Change in hip vBMC
Other outcome measures
Change in BMC and BMD at regions of interest around the knee
Change in serum bone markers
Side effects data
From 2016 Phase 3 trial • 245 Patients • NCT0218617121%
Nasopharyngitis
9%
Back pain
9%
Hypertension
6%
Arthralgia
6%
Constipation
6%
Headache
5%
Procedural pain
2%
Myalgia
2%
Muscle spasms
1%
Oropharyngeal cancer
1%
Urinary tract infection
1%
Subdural haematoma
1%
Laceration
1%
Rib fracture
1%
Anaemia postoperative
1%
Carotid artery stenosis
1%
Vascular encephalopathy
1%
Depressed mood
1%
Thoracic vertebral fracture
1%
Cerebral ischaemia
1%
Atrial flutter
1%
Death
1%
Device related infection
1%
Escherichia sepsis
1%
Coronary artery stenosis
1%
Cardio-respiratory arrest
1%
Carotid arteriosclerosis
1%
Cerebrovascular accident
1%
Angina unstable
1%
Implant site haematoma
1%
Non-cardiac chest pain
1%
Appendicitis perforated
1%
Cardiac failure
1%
Cholecystitis
1%
Appendicitis
1%
Pneumonia
1%
Haemorrhagic stroke
1%
Depression
1%
Benign prostatic hyperplasia
1%
Myocardial ischaemia
1%
Wolff-Parkinson-White syndrome
1%
Gastrooesophageal reflux disease
1%
Osteoarthritis
1%
Basal cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Romosozumab 210 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Females with Chronic SCIExperimental Treatment2 Interventions
12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alendronate
2012
Completed Phase 4
~6930
Romosozumab
2021
Completed Phase 4
~13910
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,592 Previous Clinical Trials
918,030 Total Patients Enrolled
AmgenIndustry Sponsor
1,380 Previous Clinical Trials
1,379,609 Total Patients Enrolled
Thomas J Schnitzer, MD, PhDPrincipal InvestigatorNorthwestern University
10 Previous Clinical Trials
498 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Females with Chronic SCI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger