Back to resultsMuscle Impact of Treating Osteoporosis (MITO)
Primary Purpose
Sarcopenia, Osteoporosis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Denosumab
Zoledronic Acid
Denosumab Placebo
Zoledronic Acid Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria: Ambulatory adults age ≥65 years including those using assistive devices to maximize generalizability, if they have criteria for treating osteoporosis including: Osteoporosis by axial bone density (spine, hip or forearm BMD T-score ≤-2.5 SD) or 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. Exclusion Criteria: Patients with a calculated creatinine clearance < 35 ml/min or Who have a contraindication for bisphosphonates or denosumab or Those who are scheduled for a tooth extraction to avoid jaw osteonecrosis or Subjects with severe liver disease or 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 Men
Sites / Locations
- University of PittsburghRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Zoledronic Acid
Denosumab
Arm Description
Outcomes
Primary Outcome Measures
Percentage change from baseline in muscle mass (kg) measured by D3-Creatine
D3-Creatine dilution method is a novel method to measure muscle mass
Percentage change from baseline in appendicular lean mass (ALM/body mass index)
Appendicular lean mass is measured by whole body DXA scan and is an index of skeletal muscle mass
Percentage change from baseline in trabecular bone score (TBS)
TBS is measure of bone microarchitecture and is measured by a DXA system. A value of ≥ 1.35 indicates a normal architecture while TBS ≤ 1.20 indicates degraded microarchitecture
Percentage change from baseline in bone mineral density (BMD) (g/cm²)
BMD is measured by a DXA scan system and a higher BMD is correlated with lower fracture risk
Percentage change from baseline in grip strength (kgf)
Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer
Percentage change from baseline in gait speed (m/s)
Gait speed is a measure of muscle function and will be measured by standard 4 meter gait speed test
Percentage change from baseline in rectus femoris muscle thickness (cm)
This variable will be measured by ultrasound
Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²)
This variable will be measured by ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT05666310
First Posted
December 15, 2022
Last Updated
October 21, 2023
Sponsor
Nami Safai Haeri
Collaborators
The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05666310
Brief Title
Muscle Impact of Treating Osteoporosis
Acronym
MITO
Official Title
The Impact of Osteoporosis Medications on Muscle Health in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nami Safai Haeri
Collaborators
The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zoledronic Acid
Arm Type
Active Comparator
Arm Title
Denosumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Denosumab
Intervention Description
Half of study participants will randomly receive denosumab 60 mg subcutaneous injection at month 0 and 6 with zoledronic acid placebo at month 0.
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Intervention Description
Half of study participants will randomly receive zoledronic acid 5 mg intravenous infusion at month 0 with denosumab placebo at month 0 and 6. All forty participants will receive zoledronic acid 5 mg intravenous infusion at month 12.
Intervention Type
Other
Intervention Name(s)
Denosumab Placebo
Intervention Description
Half of study participants who will randomly receive zoledronic acid 5 mg intravenous infusion at month 0 will also receive denosumab placebo at month 0 and 6.
Intervention Type
Other
Intervention Name(s)
Zoledronic Acid Placebo
Intervention Description
Half of study participants who will randomly receive denosumab 60 mg subcutaneous injection at month 0 and 6 will also receive zoledronic acid placebo.
Primary Outcome Measure Information:
Title
Percentage change from baseline in muscle mass (kg) measured by D3-Creatine
Description
D3-Creatine dilution method is a novel method to measure muscle mass
Time Frame
Baseline vs Month 12
Title
Percentage change from baseline in appendicular lean mass (ALM/body mass index)
Description
Appendicular lean mass is measured by whole body DXA scan and is an index of skeletal muscle mass
Time Frame
Baseline vs Month 12
Title
Percentage change from baseline in trabecular bone score (TBS)
Description
TBS is measure of bone microarchitecture and is measured by a DXA system. A value of ≥ 1.35 indicates a normal architecture while TBS ≤ 1.20 indicates degraded microarchitecture
Time Frame
Baseline vs Month 12
Title
Percentage change from baseline in bone mineral density (BMD) (g/cm²)
Description
BMD is measured by a DXA scan system and a higher BMD is correlated with lower fracture risk
Time Frame
Baseline vs Month 12
Title
Percentage change from baseline in grip strength (kgf)
Description
Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer
Time Frame
Baseline vs Month 12
Title
Percentage change from baseline in gait speed (m/s)
Description
Gait speed is a measure of muscle function and will be measured by standard 4 meter gait speed test
Time Frame
Baseline vs Month 12
Title
Percentage change from baseline in rectus femoris muscle thickness (cm)
Description
This variable will be measured by ultrasound
Time Frame
Baseline vs Month 12
Title
Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²)
Description
This variable will be measured by ultrasound
Time Frame
Baseline vs Month 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ambulatory adults age ≥65 years including those using assistive devices to maximize generalizability, if they have criteria for treating osteoporosis including:
Osteoporosis by axial bone density (spine, hip or forearm BMD T-score ≤-2.5 SD) or
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.
Exclusion Criteria:
Patients with a calculated creatinine clearance < 35 ml/min or
Who have a contraindication for bisphosphonates or denosumab or
Those who are scheduled for a tooth extraction to avoid jaw osteonecrosis or
Subjects with severe liver disease or
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
Men
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nami Safai Haeri, MD
Phone
412-864-1145
Email
nas287@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Greenspan, MD
Phone
412-864-1145
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nami Safai Haeri, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nami Safai Haeri, MD
Email
nas287@pitt.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Muscle Impact of Treating Osteoporosis
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