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Monoclonal Antibodies

Osteoporosis Medications for Muscle Health in Osteoporosis (MITO Trial)

Phase 4

Waitlist Available

Led By Nami Safai Haeri, MD

Research Sponsored by Nami Safai Haeri

Eligibility Criteria Checklist

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

Must have

A previous adult fragility fracture of the spine or hip or

Would be treated based on FRAX National Osteoporosis Foundation treatment thresholds of a 10-year risk of ≥ 20% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline vs month 12

Awards & highlights

MITO Trial Summary

This trial will investigate the relationship between bone and muscle health in older adults with osteoporosis, and the effects of osteoporosis treatment on muscle health.

Who is the study for?

This trial is for adults aged 65 or older with osteoporosis, diagnosed either by a previous spine or hip fracture, or low bone density scores. It's open to those who need treatment based on their risk of fractures. Men and people with severe kidney issues, contraindications for the drugs being tested, recent bisphosphonate use, planned tooth extractions, or severe liver disease cannot participate.Check my eligibility

What is being tested?

The study tests how osteoporosis medications affect muscle health in older adults. Participants will receive either Denosumab or Zoledronic Acid versus placebos to see if these treatments have an impact on muscle strength and function as well as bone health.See study design

What are the potential side effects?

Denosumab and Zoledronic Acid can cause side effects like infection risks due to lowered immunity, potential jawbone problems (osteonecrosis), discomfort at the injection site for Denosumab, flu-like symptoms after taking Zoledronic Acid infusion.

MITO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had a fracture in my spine or hip from a minor injury as an adult.

Select...

I am at high risk for major bone fractures according to FRAX scores.

Select...

I am 65 or older and meet the criteria for treating osteoporosis.

MITO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline vs month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline vs month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage change from baseline in appendicular lean mass (ALM/body mass index)

Percentage change from baseline in bone mineral density (BMD) (g/cm²)

Percentage change from baseline in gait speed (m/s)

+5 more

MITO Trial Design

2Treatment groups

Active Control

Group I: Zoledronic AcidActive Control2 Interventions

Group II: DenosumabActive Control2 Interventions

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,005,044 Total Patients Enrolled

22 Trials studying Osteoporosis

12,248 Patients Enrolled for Osteoporosis

Nami Safai HaeriLead Sponsor

The Claude D. Pepper Older Americans Independence CentersOTHER

9 Previous Clinical Trials

278 Total Patients Enrolled

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05666310 — Phase 4

Osteoporosis Research Study Groups: Zoledronic Acid, Denosumab

Osteoporosis Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT05666310 — Phase 4

Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05666310 — Phase 4

Frequently Asked Questions

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

Has the FDA authorized Zoledronic Acid for consumer use?

"With this being a Phase 4 trial, the safety of Zoledronic Acid has been deemed satisfactory with an assigned score of 3."

Answered by AI

Are there any opportunities for participants to join this clinical trial as of now?

"According to the information on clinicaltrials.gov, this experiment is no longer recruiting patients as it was last updated in December of 2022. Nevertheless, there are currently 242 other trials that continue to actively seek participants."

Answered by AI