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RISEDRONATE · 9 trials · 9 indications
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 5 mg/day risedronate |
| 2 | PLACEBO_COMPARATOR | - |
| Risedronate | EXPERIMENTAL | 35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years |
| 3 | EXPERIMENTAL | One risedronate 35 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. |
| 4 | EXPERIMENTAL | One risedronate 35 mg IR tablet taken following an overnight fast, 30 minutes before ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. |
| Name | Type | Description |
|---|---|---|
| risedronate | DRUG | 5 mg tablet of risedronate once a day for 2 years |
| risedronate placebo | DRUG | placebo for risedronate tablets (once a week dose) |
| Risedronate (HMR4003) | DRUG | - |
| Placebo tablet | DRUG | one placebo once a week for two years followed by one 35 mg risedronate once a week for two years |
| alendronate | DRUG | 0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks |
Inclusion Criteria: * have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study) Exclusion Criteria: * Can not use any bone modifying substances except risedronate
RISEDRONATE is used for postmenopausal osteoporosis, including osteoporosis in postmenopausal women, and osteopenia. It is a small molecule being developed by Sanofi for these bone-related conditions in postmenopausal women.
RISEDRONATE is a bisphosphonate that works by inhibiting bone resorption. It does not target a specific molecular receptor but acts on bone tissue to reduce the activity of osteoclasts, the cells that break down bone.
RISEDRONATE is being developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug for postmenopausal osteoporosis and related bone density conditions.
RISEDRONATE has completed Phase 3 clinical trials for postmenopausal osteoporosis. It is an investigational drug that has been studied in multiple completed trials, including a large Phase 3 study with over 1,200 participants.
RISEDRONATE has been studied in several completed trials. NCT00358176 was a Phase 3 trial of risedronate 75mg dosed on two consecutive days monthly in postmenopausal women with osteoporosis. NCT00577421 assessed bone mineral density and bone turnover with 5mg daily risedronate in postmenopausal women.
RISEDRONATE is the active ingredient in medications that may be known by brand names such as Actonel. It is a bisphosphonate used to treat and prevent osteoporosis in postmenopausal women.