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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Seoul National University Bundang Hospital | OTHER |
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The purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.
There are two major considerations in the use of bisphosphonates in diabetic patients.
The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-diabetes | Active Comparator | postmenopausal women with normal glucose tolerance |
|
| diabetes | Experimental | postmenopausal women with type 2 diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate Oral Tablet | Drug | 150 mg of ibandronate + 24,000 IU of cholecalciferol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density | . Percentage change in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck, presented as least square mean and 95% confidence interval. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bone turnover markers | Percentage change in bone turnover markers [Serum C-telopeptide (CTx) and procollagen type 1 N-terminal propeptide (P1NP) levels were measured by immunoassay methods using Elecsys kits - 07296355001V4 and 07296509001V4 (Roche Diagnostic Corp., Basel, Switzerland) ] presented as adjusted mean and 95% confidence interval using the generalized estimating equations for repeated measures analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki-Hyun Baek, M.D., Ph.D. | Yeouido St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeouido St.Mary's Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35410197 | Derived | Kim J, Kim KM, Lim S, Kang MI, Baek KH, Min YK. Efficacy of bisphosphonate therapy on postmenopausal osteoporotic women with and without diabetes: a prospective trial. BMC Endocr Disord. 2022 Apr 11;22(1):99. doi: 10.1186/s12902-022-01010-w. |
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The data that support the findings of this study are available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| D002119 | Calcium Carbonate |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| 6 month and 12 month |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D017610 |
| Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |