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In the randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of monthly oral minodronate were examined and compared to that of weekly oral alendronate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alendronate Sodium Tablets and Minodronate Tablets -matching placebo | Active Comparator | subjects received 70 mg alendronate sodium tablet weekly and a minodronate tablet matching placebo monthly for 48 weeks. |
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| Minodronate Tablets and Alendronate Sodium Tablets-matching placebo | Experimental | subjects received 50mg minodronate tablets monthly and an alendronate sodium tablets -matching placebo weekly for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo | Drug | all subjects will receive Calcium Carbonate and Vitamin D3 Tablets as basic medication. |
| Measure | Description | Time Frame |
|---|---|---|
| The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 48 weeks after administration and before administration .the group of minodronate were examined and compared to that of alendronate. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 24 weeks after administration and before administration . | 24weeks | |
| The change rate of bone turnover markers from baseline to 12、24、48 weeks, including serum type I collagen amino terminal peptide(P1NP) and serum C-terminal telopeptide of type 1 collagen (S-CTX ). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang jian xiang | Contact | 0539-8330397 | jianxiangzhang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong New Time Pharmaceutical Co., LTD | Shandong | China |
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| 12、24、48 weeks, |
| the change rates of bone density at the femoral neck and the whole hip from baseline to the end of 24 and 48 weeks. | 24、48 weeks |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C087958 | YM 529 |
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