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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG024827 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Claude D. Pepper Older Americans Independence Centers | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic Acid | Active Comparator |
| |
| Denosumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Half of study participants will randomly receive denosumab 60 mg subcutaneous injection at month 0 and 6 with zoledronic acid placebo at month 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in muscle mass (kg) measured by D3-Creatine | D3-Creatine dilution method is a novel method to measure muscle mass | Baseline vs Month 12 |
| 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 | Baseline vs Month 12 |
| 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 | Baseline vs Month 12 |
| 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 | Baseline vs Month 12 |
| Percentage change from baseline in grip strength (kgf) | Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer | Baseline vs Month 12 |
| 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 | Baseline vs Month 12 |
| Percentage change from baseline in rectus femoris muscle thickness (cm) |
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Inclusion Criteria:
Ambulatory adults age ≥65 years including those using assistive devices to maximize generalizability, if they have criteria for treating osteoporosis including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nami Safai Haeri, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2023 | Feb 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Zoledronic Acid | Drug | 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. |
|
| Denosumab Placebo | Other | 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. |
|
| Zoledronic Acid Placebo | Other | Half of study participants who will randomly receive denosumab 60 mg subcutaneous injection at month 0 and 6 will also receive zoledronic acid placebo. |
|
This variable will be measured by ultrasound
| Baseline vs Month 12 |
| Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²) | This variable will be measured by ultrasound | Baseline vs Month 12 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |