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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK032333 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of the study is to determine the effect of forearm exercise on forearm bone density in post-menopausal women with or without primary hyperparathyroidism.
The investigators hypothesize that forearm exercise will increase forearm bone density in patients with primary hyperparathyroidism more so than in patients without primary hyperparathyroidism.
Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone (PTH) and high blood calcium, is one of the most common endocrine disorders.
PHPT is seen most often in post-menopausal women. Kidney stones and bone deformities were prominent manifestations of the disease in the past, however, PHPT is now primarily asymptomatic due to incidental detection of high blood calcium levels.
Many patients with PHPT, however, have low bone mineral density (BMD) when bone mass is measured by dual energy x-ray absorptiometry (DXA), primarily at the forearm.
There is no effective medical therapy which increases bone density at the forearm in patients with PHPT. PTH both builds and breaks down bone, and the pathways by which PTH mediates these actions are beginning to be identified. Prior research suggests that mechanical loading shifts PTH towards building bone. Arm exercise is an attractive option for the treatment of low forearm BMD in patients with PHPT since it is often the site most affected by excess PTH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHPT/ Walking + Forearm exercise | Experimental | Ten participants with PHPT will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking. |
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| PHPT/ Walking alone | Placebo Comparator | Ten participants with PHPT will be randomized to the intervention of 52 weeks of the walking program alone. Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks. |
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| Osteopenia/ Walking + Forearm exercise | Active Comparator | Ten healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking. |
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| Osteopenia/ Walking alone | Placebo Comparator | Ten healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the walking program alone. Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forearm exercise program | Other | Participants assigned to forearm exercise will receive training in forearm strengthening exercises from a doctoral occupational therapy student. Participants will be taught 8 exercises and are performed at home. The exercise program is designed to take about 30 minutes per session. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with improved bone mass and bone quality at the 1/3 radius | The primary outcome is proportion of subjects with improved bone mass and bone quality at the 1/3 radius over one year. | 1 year |
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Inclusion Criteria:
Inclusion criteria for primary hyperparathyroidism group:
Inclusion criteria for the osteopenic control:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Bilezikian, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this study, "The Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism" | View source |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D001851 | Bone Diseases, Metabolic |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D016138 | Walking |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Walking program | Other | Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks. The walking program for all participants constitutes the control/placebo comparator. |
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| D009140 |
| Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010024 | Osteoporosis |
| D015444 | Exercise |
| D009043 | Motor Activity |