Muscle Impact of Treating Osteoporosis (MITO)

Nami Safai Haeri

Status and phase: Active, not recruiting; Phase 4

Conditions: Osteoporosis; Sarcopenia

Treatments: Drug: Denosumab; Other: Zoledronic Acid Placebo; Other: Denosumab Placebo; Drug: Zoledronic Acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05666310

STUDY22080139

P30AG024827 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity). There is strong evidence of overlap between the pathophysiology of osteoporosis and sarcopenia (muscle-bone crosstalk). This research plan will further explore the relationship between bone and muscle, and provide new information about effect of osteoporosis medications on muscle health in older adults who are under treatment for osteoporosis.

Enrollment: 20 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Ambulatory adults age ≥65 years including those using assistive devices to maximize generalizability, if they have criteria for treating osteoporosis including:

1. Osteoporosis by axial bone density (spine, hip or forearm BMD T-score ≤-2.5 SD) or
2. A previous adult fragility fracture of the spine or hip or
3. 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.

Exclusion criteria

1. Patients with a calculated creatinine clearance < 35 ml/min or
2. Who have a contraindication for bisphosphonates or denosumab or
3. Those who are scheduled for a tooth extraction to avoid jaw osteonecrosis or
4. Subjects with severe liver disease or
5. Those who have been on oral bisphosphonates for the past 1 year and intravenous bisphosphonates for the past 2 years prior to the study or
6. Men

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Zoledronic Acid

Active Comparator group

Treatment:

Other: Denosumab Placebo

Drug: Zoledronic Acid

Denosumab

Active Comparator group

Treatment:

Other: Zoledronic Acid Placebo

Drug: Denosumab