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| ID | Type | Description | Link |
|---|---|---|---|
| HMR4003B/3001 |
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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women
To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption
To confirm general safety of 5 mg daily risedronate as compared to placebo
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risedronate (HMR4003) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA) | ||
| Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24 | ||
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Inclusion Criteria:
Ambulatory, healthy postmenopausal women with
With at least one risk factor for osteoporosis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Välimäki Matti, MD | Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Helsinki | Finland | ||||
| Sanofi-Aventis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18035193 | Result | Valimaki MJ, Farrerons-Minguella J, Halse J, Kroger H, Maroni M, Mulder H, Munoz-Torres M, Saaf M, Snorre Ofjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49. doi: 10.1016/j.clinthera.2007.09.017. |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Percent changes in bone turnover markers after 12 and 24 months of treatment |
| Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment |
| Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events |
| Gouda |
| Netherlands |
| Sanofi-Aventis | Oslo | Norway |
| Sanofi-Aventis | Madrid | Spain |
| Sanofi-Aventis | Stockholm | Sweden |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |