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Monoclonal Antibodies

Romosozumab + Zoledronic Acid for Osteoporosis (RUBI Trial)

Phase 4
Recruiting
Led By Susan L Greenspan, MD
Research Sponsored by Susan L. Greenspan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elderly women 65 years and older who reside in an institution (nursing home or assisted living facility or senior care community)
Those with osteoporosis by axial bone density (spine, hip or forearm BMD T-score≤ -2.5 SD), a previous adult fragility fracture of the spine or hip, or meet treatment thresholds based on FRAX and the National Osteoporosis Foundation (NOF) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

RUBI Trial Summary

This trial will test if a yearly injection of romosozumab, followed by an infusion of zoledronic acid, can help treat and prevent bone loss in older women with osteoporosis who live in long-term care facilities.

Who is the study for?
This trial is for women aged 65 or older with osteoporosis, living in long-term care facilities. They must have a bone density score of -2.5 SD or lower, a history of fractures, or meet certain risk criteria. Excluded are non-walkers, those with recent severe heart issues, kidney problems preventing IV treatment, recent stroke or heart attack victims, current users of specific osteoporosis meds and very low vitamin D levels.Check my eligibility
What is being tested?
The study tests if romosozumab injections followed by zoledronic acid infusion can improve bone health in elderly women with osteoporosis at LTC facilities. It compares the effects to placebo treatments alongside standard calcium and vitamin D supplements.See study design
What are the potential side effects?
Romosozumab may cause muscle pain, joint pain, headache; serious side effects include possible increased risk of heart attack and stroke. Zoledronic acid might lead to flu-like symptoms, fever; rarely it can cause jawbone problems and unusual thigh bone fractures.

RUBI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 65 or older living in a care facility.
Select...
I have osteoporosis or had a major bone fracture.

RUBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Bone Mineral Density of the spine
Bone Mineral Density of the total hip

Side effects data

From 2016 Phase 3 trial • 245 Patients • NCT02186171
21%
Nasopharyngitis
9%
Back pain
9%
Hypertension
6%
Arthralgia
6%
Constipation
6%
Headache
5%
Procedural pain
2%
Muscle spasms
2%
Myalgia
1%
Cerebral ischaemia
1%
Thoracic vertebral fracture
1%
Urinary tract infection
1%
Subdural haematoma
1%
Laceration
1%
Rib fracture
1%
Anaemia postoperative
1%
Oropharyngeal cancer
1%
Carotid artery stenosis
1%
Vascular encephalopathy
1%
Depressed mood
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

RUBI Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Romosozumab, then Zoledronic AcidExperimental Treatment3 Interventions
Monthly dose: 210 mg Romosozumab subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit.
Group II: Placebo, then Zoledronic AcidPlacebo Group3 Interventions
Monthly dose: placebo saline subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romosozumab
FDA approved
Zoledronic acid
FDA approved
Calcium and Vitamin D
2018
Completed Phase 4
~490

Find a Location

Who is running the clinical trial?

Susan L. GreenspanLead Sponsor
5 Previous Clinical Trials
881 Total Patients Enrolled
5 Trials studying Osteoporosis
881 Patients Enrolled for Osteoporosis
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,397 Total Patients Enrolled
10 Trials studying Osteoporosis
2,029 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,863 Total Patients Enrolled
22 Trials studying Osteoporosis
12,068 Patients Enrolled for Osteoporosis

Media Library

Romosozumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05058976 — Phase 4
Osteoporosis Research Study Groups: Romosozumab, then Zoledronic Acid, Placebo, then Zoledronic Acid
Osteoporosis Clinical Trial 2023: Romosozumab Highlights & Side Effects. Trial Name: NCT05058976 — Phase 4
Romosozumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05058976 — Phase 4

Frequently Asked Questions

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

What potential health risks are associated with Romosozumab treatment?

"There is evidence for Romosozumab's safety, thus it has been given a score of 3. This treatment has already cleared Phase 4 trials and can be prescribed to patients in need."

Answered by AI

Have previous investigations into Romosozumab been conducted?

"Currently, there are 46 active studies concerning Romosozumab with 10 trials in the third phase. The primary site for these clinical tests is Douliu, Yunlin County; yet, this medication has been trialled across 751 different locations worldwide."

Answered by AI

How many patients have been enrolled in this clinical trial thus far?

"Affirmative, the information hosted on clinicaltrials.gov testifies that this experiment is recruiting participants at present. Initially posted on September 15th 2021, it has since been updated as recently as 7/9/2022 and requires 200 volunteers from 1 medical centre to participate."

Answered by AI

What conditions does Romosozumab typically ameliorate?

"Romosozumab is a therapeutic agent used to combat glucocorticoids. Furthermore, it has been demonstrated to be effective in the treatment of solid tumors, malignant neoplasms, and osteoporosis."

Answered by AI

Is this research endeavor presently welcoming participants?

"Affirmative. According to clinicaltrials.gov, this experiement is at present recruiting participants after being initially posted on September 15th 2021 and last edited on September 7th 2022. 200 individuals need to be enlisted from a single medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
UPMC Senior Communities
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Romosozumab Use to Build Skeletal Integrity
Susan L. Greenspan 2021. "Romosozumab Use to Build Skeletal Integrity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05058976.
All > Osteoporosis > Vitamin D
~113 spots leftby Sep 2027
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