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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

Must not have

Current or recent therapy with specific osteoporosis medications

Non-ambulatory residents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged 65 or older living in a care facility.

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I have osteoporosis or had a major bone fracture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking or have recently taken medication for osteoporosis.

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I am unable to walk on my own.

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I have had recent heart problems or chest pain.

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I have not had a heart attack or stroke in the last year.

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I cannot take certain bone-strengthening IV drugs due to poor kidney function.

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I am not expected to live or be discharged within the next 2 years due to my illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Hypertension

Back pain

Constipation

Arthralgia

Headache

Procedural pain

Muscle spasms

Myalgia

Depression

Appendicitis perforated

Pneumonia

Implant site haematoma

Thoracic vertebral fracture

Death

Cerebral ischaemia

Depressed mood

Atrial flutter

Appendicitis

Osteoarthritis

Vascular encephalopathy

Urinary tract infection

Carotid artery stenosis

Anaemia postoperative

Haemorrhagic stroke

Cholecystitis

Non-cardiac chest pain

Basal cell carcinoma

Benign prostatic hyperplasia

Angina unstable

Cardio-respiratory arrest

Coronary artery stenosis

Wolff-Parkinson-White syndrome

Cerebrovascular accident

Escherichia sepsis

Subdural haematoma

Oropharyngeal cancer

Device related infection

Myocardial ischaemia

Gastrooesophageal reflux disease

Carotid arteriosclerosis

Cardiac failure

Laceration

Rib fracture

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Romosozumab 210 mg

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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