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Bisphosphonates

Romosozumab for Osteogenesis Imperfecta

Q: Are multiple medical facilities in the city conducting this research study?

Presently, this clinical research is operational in 23 diverse locations including Bratislava, Nashville, and Okayama-shi. Opting for the nearest site minimizes travel-related obligations upon enrollment.

Q: What is the current number of individuals being enrolled in this research project?

A total of 106 eligible individuals meeting the specified criteria are sought to enroll in this research. Potential participants can join from diverse locations such as Narodny ustav detskych chorob in Bratislava, <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a>, and Vanderbilt University Medical Center in Nashville, Okayama.

Q: Are individuals above the age of 70 being sought for enrollment in this study?

This research study is seeking to enroll individuals aged above 5 years old but below 17 years of age.

Q: Are new participants currently being sought for this medical study?

Indeed, the details available on clinicaltrials.gov show that this medical investigation is actively pursuing potential participants. Initially shared on April 22nd, 2024, and most recently revised on the same date, it aims to recruit a total of 106 patients spread across 23 different sites.

Q: Which individuals are eligible to participate in this clinical investigation?

This research study seeks to enroll 106 individuals aged between 5 and 17 years with <a href="https://www.withpower.com/clinical-trials/osteogenesis-imperfecta">osteogenesis imperfecta</a>. Eligible participants must have a lumbar spine Z-score of ≤-1.0, provide informed consent or assent according to local regulations, be ambulatory children or teenagers aged 5 to &#x3C;18 years (with or without assistance), belong to families with autosomal dominant inheritance if the condition is familial, clinically diagnosed as OI type I, III, or IV based on characteristic features and fracture history within the last two years meeting specific criteria.

Q: Has Romosozumab been granted official approval by the FDA?

Based on our assessment at Power, the safety rating for Romosozumab in this Phase 3 trial is a maximum score of 3. This indicates that there exists preliminary data suggesting effectiveness and robust evidence supporting its safety profile.

Phase 3

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets at least one of the following: 3 or more fractures within the previous 2 years, or 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or 2 or more prevalent vertebral fractures

Ambulatory male and female children and adolescents, age 5 to <18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12 to month 15

Awards & highlights

Study Summary

This trial aims to compare the effects of romosozumab and bisphosphonate treatment over 12 months on the number of fractures and changes in bone density at specific time points.

Who is the study for?

This trial is for children and adolescents aged 5 to less than 18 with Osteogenesis Imperfecta (OI), a condition that makes bones fragile. Participants must have had at least three fractures in the past two years or one nonvertebral fracture plus a vertebral fracture, or two vertebral fractures. They need a lumbar spine Z-score of ≤-1.0 and must be able to walk, with assistance if necessary.Check my eligibility

What is being tested?

The study compares Romosozumab with Bisphosphonates over 12 months to see which treatment better reduces the number of bone fractures in kids with OI. It also looks at changes in bone density after six months. The goal is to find out if Romosozumab can improve bone strength more effectively than current treatments.See study design

What are the potential side effects?

Possible side effects of Romosozumab may include joint pain, headache, injection site reactions like redness and swelling, and possibly an increased risk of heart problems. Bisphosphonates might cause stomach pain, nausea, jawbone problems, and rarely unusual thigh bone fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had 3 or more fractures in the last 2 years or at least 1 non-spine fracture and 1 spine fracture.

Select...

I am a child or teenager aged 5 to under 18 years old and can move around with or without help.

Select...

My family's condition is passed down directly from one parent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12 to month 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12 to month 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 to month 15 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 from Baseline to 6 Months in Lumbar Spine BMD Z-score

Number of Any Fractures

Number of Clinical Fractures

Secondary outcome measures

Change from Baseline in Child Health Questionnaire - Parent Version (CHQ-PF-50) Physical Summary Score

Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ-CV) Disability Score

Change from Baseline in the Wong-Baker Faces Pain Rating Scale

+21 more

Side effects data

From 2016 Phase 3 trial • 245 Patients • NCT02186171

21%

Nasopharyngitis

Back pain

Hypertension

Arthralgia

Constipation

Headache

Procedural pain

Myalgia

Muscle spasms

Oropharyngeal cancer

Urinary tract infection

Subdural haematoma

Laceration

Rib fracture

Anaemia postoperative

Carotid artery stenosis

Vascular encephalopathy

Depressed mood

Thoracic vertebral fracture

Cerebral ischaemia

Atrial flutter

Death

Device related infection

Escherichia sepsis

Coronary artery stenosis

Cardio-respiratory arrest

Carotid arteriosclerosis

Cerebrovascular accident

Angina unstable

Implant site haematoma

Non-cardiac chest pain

Appendicitis perforated

Cardiac failure

Cholecystitis

Appendicitis

Pneumonia

Haemorrhagic stroke

Depression

Benign prostatic hyperplasia

Myocardial ischaemia

Wolff-Parkinson-White syndrome

Gastrooesophageal reflux disease

Osteoarthritis

Basal cell carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Romosozumab 210 mg

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RomosozumabExperimental Treatment1 Intervention

Participants will receive romosozumab once a month (QM) for 12 months.

Group II: Standard of Care BisphosphonateActive Control1 Intervention

Participants will receive bisphosphonates per local standard of care treatment regimens, as determined by the investigator for 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romosozumab

2021

Completed Phase 4

~13910

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,380 Previous Clinical Trials

1,379,515 Total Patients Enrolled

3 Trials studying Osteogenesis Imperfecta

253 Patients Enrolled for Osteogenesis Imperfecta

MDStudy DirectorAmgen

925 Previous Clinical Trials

926,538 Total Patients Enrolled

3 Trials studying Osteogenesis Imperfecta

253 Patients Enrolled for Osteogenesis Imperfecta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are multiple medical facilities in the city conducting this research study?

"Presently, this clinical research is operational in 23 diverse locations including Bratislava, Nashville, and Okayama-shi. Opting for the nearest site minimizes travel-related obligations upon enrollment."

Answered by AI

What is the current number of individuals being enrolled in this research project?

"A total of 106 eligible individuals meeting the specified criteria are sought to enroll in this research. Potential participants can join from diverse locations such as Narodny ustav detskych chorob in Bratislava, Tennessee, and Vanderbilt University Medical Center in Nashville, Okayama."

Answered by AI

Are individuals above the age of 70 being sought for enrollment in this study?

"This research study is seeking to enroll individuals aged above 5 years old but below 17 years of age."

Answered by AI

Are new participants currently being sought for this medical study?

"Indeed, the details available on clinicaltrials.gov show that this medical investigation is actively pursuing potential participants. Initially shared on April 22nd, 2024, and most recently revised on the same date, it aims to recruit a total of 106 patients spread across 23 different sites."

Answered by AI

Which individuals are eligible to participate in this clinical investigation?

"This research study seeks to enroll 106 individuals aged between 5 and 17 years with osteogenesis imperfecta. Eligible participants must have a lumbar spine Z-score of ≤-1.0, provide informed consent or assent according to local regulations, be ambulatory children or teenagers aged 5 to <18 years (with or without assistance), belong to families with autosomal dominant inheritance if the condition is familial, clinically diagnosed as OI type I, III, or IV based on characteristic features and fracture history within the last two years meeting specific criteria."

Answered by AI

Has Romosozumab been granted official approval by the FDA?

"Based on our assessment at Power, the safety rating for Romosozumab in this Phase 3 trial is a maximum score of 3. This indicates that there exists preliminary data suggesting effectiveness and robust evidence supporting its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

2024. "Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972551.

All > Osteogenesis Imperfecta