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| Name | Class |
|---|---|
| Columbia University | OTHER |
| MaineHealth | OTHER |
| University of California, San Francisco | OTHER |
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Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atenolol | Experimental | Study subjects will take Atenolol 50 mg daily over 2 years |
|
| Placebo | Placebo Comparator | Study subjects will take a placebo daily over 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atenolol 50 MG | Drug | 50 mg Atenolol daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome: Percent change in total hip bone mineral density (BMD) | Percent change in total hip bone mineral density (BMD) by DXA | Baseline, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcomes: Percent changes in lumbar spine and femur neck BMD | Percent changes in lumbar spine and femur neck BMD | Baseline, 24 months |
| Additional secondary outcomes | Percent changes in radius and ultra-distal radius BMD using DXA and in bone turnover markers (CTx, PINP). |
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Inclusion Criteria:
Exclusion Criteria:
Clinical diagnosis of diabetes mellitus requiring insulin
Clinically significant abnormality in any of the additional screening laboratory studies
A1c- ≥8
Calcium - > upper limit lab value per site
AST- 2x upper normal limit
FSH- < 16IU/L
eGFR- < 45 mL/min/1.73m2 based on creatinine
CBC- Per PI interpretation of each patient
Presence of (documented clinical diagnosis of any of the following):
Undergoing treatment with any medications that affect bone turnover, including the following:
Any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable)
Bilateral hip replacements or metal in both hips
Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure vitamin D sufficiency
Resting systolic blood pressure < 115 mm Hg, heart rate < 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff)
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| Name | Affiliation | Role |
|---|---|---|
| Sundeep Khosla, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MaineHealth | Scarborough | Maine | 04074 | United States | ||
| Mayo Clinic |
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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 | Nov 17, 2023 | Aug 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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Atenolol vs. Placebo
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| Placebo | Drug | one placebo daily |
|
| Baseline, intermediate timepoints, 24 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |