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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)
SCI 6 or more months prior to enrollment
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 below
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I cannot walk or have severe difficulty walking.
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I had a spinal cord injury more than 6 months ago.
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I do not have diabetes or untreated thyroid conditions.
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I can sit upright and take pills for at least 30 minutes.
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I can attend all required study visits.
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I am female.
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I have osteoporosis, confirmed by a DXA scan.
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I am 18 years old or older.
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I am using or willing to use birth control or practice abstinence during and up to 3 months after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 12 months for reporting.

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 • NCT02186171
21%
Nasopharyngitis
9%
Hypertension
9%
Back pain
6%
Constipation
6%
Headache
6%
Arthralgia
5%
Procedural pain
2%
Muscle spasms
2%
Myalgia
1%
Cholecystitis
1%
Pneumonia
1%
Haemorrhagic stroke
1%
Depressed mood
1%
Depression
1%
Device related infection
1%
Benign prostatic hyperplasia
1%
Appendicitis
1%
Non-cardiac chest pain
1%
Cardio-respiratory arrest
1%
Coronary artery stenosis
1%
Appendicitis perforated
1%
Implant site haematoma
1%
Escherichia sepsis
1%
Thoracic vertebral fracture
1%
Carotid arteriosclerosis
1%
Cerebral ischaemia
1%
Cerebrovascular accident
1%
Vascular encephalopathy
1%
Oropharyngeal cancer
1%
Carotid artery stenosis
1%
Cardiac failure
1%
Angina unstable
1%
Atrial flutter
1%
Myocardial ischaemia
1%
Wolff-Parkinson-White syndrome
1%
Gastrooesophageal reflux disease
1%
Death
1%
Urinary tract infection
1%
Anaemia postoperative
1%
Laceration
1%
Rib fracture
1%
Subdural haematoma
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
1,576 Previous Clinical Trials
911,910 Total Patients Enrolled
6 Trials studying Osteoporosis
246 Patients Enrolled for Osteoporosis
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,059 Total Patients Enrolled
53 Trials studying Osteoporosis
550,561 Patients Enrolled for Osteoporosis
Thomas J Schnitzer, MD, PhDPrincipal InvestigatorNorthwestern University
10 Previous Clinical Trials
498 Total Patients Enrolled
4 Trials studying Osteoporosis
114 Patients Enrolled for Osteoporosis

Media Library

Romosozumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04708886 — Phase 2
Osteoporosis Research Study Groups: Females with Chronic SCI
Osteoporosis Clinical Trial 2023: Romosozumab Highlights & Side Effects. Trial Name: NCT04708886 — Phase 2
Romosozumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04708886 — Phase 2

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
~1 spots leftby Sep 2024