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| ID | Type | Description | Link |
|---|---|---|---|
| HMR4003M/3001 |
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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.
To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.
To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate (HMR4003) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in lumbar spine bone mineral density (BMD) at | ||
| Month 12 measured by dual-energy X-ray absorptiometry (DXA). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers. | ||
| Safety: AEs, clinical laboratory values, bone biopsies. |
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Inclusion Criteria:
Subjects meeting all of the following criteria were considered for enrollment into the study :
·Ambulatory, healthy postmenopausal women with :
Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)).
Exclusion Criteria:
Subjects with any of the following criteria were not considered for enrollment into the study :
·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis |
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| Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants. |
| Physical examination before treatment and after 12 and 24 months of treatment. |
| San Isidro |
| Argentina |
| Sanofi-Aventis | Macquarie Park | Australia |
| Sanofi-Aventis | Laval | Canada |
| Sanofi-Aventis | Prague | Czechia |
| Sanofi-Aventis | Paris | France |
| Sanofi-Aventis | Beirut | Lebanon |
| Sanofi-Aventis | Warsaw | Poland |
| Sanofi-Aventis | Midrand | South Africa |
| Sanofi-Aventis | Istanbul | Turkey (Türkiye) |
| Sanofi-Aventis | Guildford Surrey | United Kingdom |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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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