Osteoporosis Medications for Muscle Health in Osteoporosis
(MITO Trial)

Recruiting in Palo Alto (17 mi)

Overseen byNami Safai Haeri, MD

Age: 65+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Nami Safai Haeri

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is studying how medications for weak bones might also help improve muscle health in older adults with both weak bones and muscles. Researchers believe these medications could benefit muscle strength and function by affecting the way bones and muscles work together.

Eligibility Criteria

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.

Inclusion Criteria

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

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

Your bone density in your spine, hip, or forearm is very low, indicating osteoporosis.

+1 more

Exclusion Criteria

I cannot take bisphosphonates or denosumab due to health reasons.

I have been taking oral bisphosphonates for 1 year or intravenous bisphosphonates for 2 years.

I am scheduled for a tooth extraction to prevent jaw bone damage.

+3 more

Participant Groups

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.

2Treatment groups

Active Control

Group I: Zoledronic AcidActive Control2 Interventions

Group II: DenosumabActive Control2 Interventions

Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Prolia for:

Osteoporosis in postmenopausal women
Bone loss associated with hormone ablation therapy for prostate cancer
Bone loss associated with hormone ablation therapy for breast cancer

🇺🇸 Approved in United States as Prolia for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

🇨🇦 Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture

🇯🇵 Approved in Japan as Prolia for: