CLINICAL TRIALS PROFILE FOR ACTONEL
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505(b)(2) Clinical Trials for ACTONEL
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT00632216 ↗ | A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis | Completed | Sanofi | Phase 4 | 2004-05-01 | The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for ACTONEL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00051636 ↗ | Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period | Completed | Novartis Pharmaceuticals | Phase 3 | 2001-01-01 | The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment. |
| NCT00054418 ↗ | Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer | Completed | National Cancer Institute (NCI) | Phase 3 | 2003-03-01 | RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer. |
| NCT00054418 ↗ | Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer | Completed | Alliance for Clinical Trials in Oncology | Phase 3 | 2003-03-01 | RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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