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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AR085647-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The goal of this clinical trial is to learn if veverimer will reduce urinary net acid excretion leading to reduced bone resorption in healthy adults with osteopenia. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veverimer 9 g/day | Experimental |
| |
| Veverimer 9 g/every other day | Experimental |
| |
| Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| veverimer daily | Drug | 8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hr urinary net acid excretion | measured at screening, week 2, week 8 and week 8 +1day |
| Measure | Description | Time Frame |
|---|---|---|
| Serum bicarbonate level | measured at screening, week 0, week 1, week 2, week 4, week 8 | |
| Serum potassium level | measured at screening, week 0, week 1, week 2, week 4, week 8 | |
| Measure | Description | Time Frame |
|---|---|---|
| Sit-to-stand time | Sit-to-stand time with higher times indicating lower strength and function | measured at week 0 and week 8 |
| Gait speed | 6-meter walking speed with higher time indicating lower function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise Danico, MS | Contact | 617-636-3232 | elise.danico@tuftsmedicine.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19727904 | Background | Dawson-Hughes B, Castaneda-Sceppa C, Harris SS, Palermo NJ, Cloutier G, Ceglia L, Dallal GE. Impact of supplementation with bicarbonate on lower-extremity muscle performance in older men and women. Osteoporos Int. 2010 Jul;21(7):1171-9. doi: 10.1007/s00198-009-1049-0. Epub 2009 Sep 1. | |
| 16449339 | Background | Bauer DC, Garnero P, Bilezikian JP, Greenspan SL, Ensrud KE, Rosen CJ, Palermo L, Black DM. Short-term changes in bone turnover markers and bone mineral density response to parathyroid hormone in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2006 Apr;91(4):1370-5. doi: 10.1210/jc.2005-1712. Epub 2006 Jan 31. |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| veverimer every other day | Drug | 8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day |
|
| Placebo | Other | 8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day |
|
| Serum C-telopeptide level |
| measured at week 0, week 2, week 8 |
| Serum procollagen type 1 N-propeptide level | measured at week 0 and week 8 |
| measured at week 0 and week 8 |
| Time-up-and-go time | time-up-and-go with 3 meter walk with higher time indicating lower function | measured at week 0 and week 8 |
| 24-hr urinary pH | measured at screening, week 2, week 8, and week 8 +1day |
| 24-hr urinary creatinine | measured at screening, week 2, week 8, and week 8 +1day |
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