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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR RISEDRONATE SODIUM


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505(b)(2) Clinical Trials for Risedronate Sodium

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 >Phase >Start Date >Summary

All Clinical Trials for Risedronate Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00043069 ↗ Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 2002-11-01 RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate 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 estrogen and/or risedronate in preventing osteoporosis. PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.
NCT00043069 ↗ Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer Completed Alliance for Clinical Trials in Oncology Phase 3 2002-11-01 RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate 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 estrogen and/or risedronate in preventing osteoporosis. PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Risedronate Sodium

Condition Name

Condition Name for Risedronate Sodium
Intervention Trials
Osteoporosis 6
Osteoporosis, Postmenopausal 4
Breast Cancer 4
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Condition MeSH

Condition MeSH for Risedronate Sodium
Intervention Trials
Osteoporosis 11
Osteoporosis, Postmenopausal 4
Breast Neoplasms 4
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Clinical Trial Locations for Risedronate Sodium

Trials by Country

Trials by Country for Risedronate Sodium
Location Trials
United States 49
Canada 10
Japan 4
United Kingdom 3
France 2
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Trials by US State

Trials by US State for Risedronate Sodium
Location Trials
Pennsylvania 3
Florida 3
North Carolina 3
Minnesota 2
Texas 2
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Clinical Trial Progress for Risedronate Sodium

Clinical Trial Phase

Clinical Trial Phase for Risedronate Sodium
Clinical Trial Phase Trials
Phase 4 6
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Risedronate Sodium
Clinical Trial Phase Trials
Completed 15
Withdrawn 1
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Clinical Trial Sponsors for Risedronate Sodium

Sponsor Name

Sponsor Name for Risedronate Sodium
Sponsor Trials
Sanofi 5
Procter and Gamble 4
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for Risedronate Sodium
Sponsor Trials
Industry 14
Other 8
NIH 3
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