What side effects are associated with this type of intervention?

Common treatments for osteoporosis, such as bisphosphonates (e.g., alendronate, zoledronic acid), denosumab, and anabolic agents (e.g., teriparatide), have several known side effects. Bisphosphonates can cause gastrointestinal issues, osteonecrosis of the jaw, and atypical femoral fractures. Denosumab may lead to rebound vertebral fractures upon discontinuation and has been associated with infections and dermatologic reactions. Anabolic agents like teriparatide can cause hypercalcemia and have a potential risk of osteosarcoma, as observed in animal studies. Patients should discuss these risks with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of osteoporosis, focusing on increasing bone mineral density (BMD) and reducing fracture risk. Bisphosphonates such as alendronate and zoledronic acid are commonly used due to their efficacy and long-term safety data. Denosumab, a monoclonal antibody, is another option, particularly for patients intolerant to bisphosphonates. Teriparatide, an anabolic agent, is reserved for severe cases. Romosozumab, a newer agent, has shown promise in increasing BMD and reducing vertebral fractures. These treatments are essential for managing osteoporosis and preventing fractures.

What other types of research exist?

Promising novel alternatives to traditional osteoporosis medications include romosozumab and the combination of exercise interventions. Romosozumab has shown significant improvements in bone mineral density and reduction in fracture risk. Additionally, structured resistance-based exercise programs have demonstrated benefits in muscle strength, lean mass, and overall fitness, which can complement osteoporosis treatment by improving both bone and muscle health.

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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.

Must not have

Who have a contraindication for bisphosphonates or denosumab or

Subjects with severe liver disease or

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline vs month 12

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

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

Select...

I cannot take bisphosphonates or denosumab due to health reasons.

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I do not have severe liver disease.

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I am a man.

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My kidney function, measured by creatinine clearance, is below 35 ml/min.

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

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

Primary study objectives

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

Awards & Highlights

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

Active Control

Group I: Zoledronic AcidActive Control2 Interventions

Group II: DenosumabActive Control2 Interventions

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoporosis include bisphosphonates, denosumab, and anabolic agents like teriparatide and romosozumab. Bisphosphonates, such as alendronate and zoledronic acid, work by inhibiting osteoclast-mediated bone resorption, thereby increasing bone mineral density (BMD). Denosumab is a monoclonal antibody that inhibits RANKL, a protein essential for the formation and function of osteoclasts, leading to reduced bone resorption and increased BMD. Anabolic agents like teriparatide and romosozumab stimulate bone formation; teriparatide is a parathyroid hormone analog that activates osteoblasts, while romosozumab inhibits sclerostin, a protein that negatively regulates bone formation. These mechanisms are crucial for osteoporosis patients as they help to strengthen bones, reduce fracture risk, and improve overall bone health.

Preventing muscle wasting by osteoporosis drug alendronate in vitro and in myopathy models via sirtuin-3 down-regulation.Additive effects of nutritional supplementation, together with bisphosphonates, on bone mineral density after hip fracture: a 12-month randomized controlled study.