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| ID | Type | Description | Link |
|---|---|---|---|
| HMR4003K/2001 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 5 mg risedronate, once daily for 6 months |
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| 2 | Experimental | 100 mg risedronate, once a month for 6 months |
|
| 3 | Experimental | 150 mg risedronate, once a month for 6 months |
|
| 4 | Experimental | 200 mg risedronate, once a month for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risedronate | Drug | tablet, 5 mg risedronate daily for 6 months |
| |
| risedronate |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:
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| Name | Affiliation | Role |
|---|---|---|
| John Beary, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Daytona Beach | Florida | United States | |||
| Research Site |
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| Drug |
tablet, 100 mg risedronate monthly for 6 months |
|
| risedronate | Drug | tablet, 150 mg risedronate monthly for 6 months |
|
| experimental | Drug | tablet, 200 mg risedronate monthly for 6 months |
|
| Gainesville |
| Florida |
| United States |
| Research Site | Shawnee Mission | Kansas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Hamilton | Ontario | Canada |
| Research Facility | Montreal | Quebec | Canada |
| Research Facility | Sainte-Foy | Quebec | Canada |
| Research Facility | Zagreb | Croatia |
| Research Facility | Amsterdam | Netherlands |
| Research Facility | Leiden | Netherlands |
| Research Facility | Bialystok | Poland |
| Research Site | Lublin | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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