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Last Updated: January 28, 2020

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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
NCT00082277 Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer Completed AstraZeneca Phase 4 2004-04-01 The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
NCT00447915 Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis Completed Chugai Pharmaceutical Phase 3 2007-03-01 To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.
NCT00452439 A Study of Actonel for the Prevention of Bone Loss Completed Procter and Gamble Phase 3 2004-02-01 The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.
NCT00452439 A Study of Actonel for the Prevention of Bone Loss Completed M.D. Anderson Cancer Center Phase 3 2004-02-01 The goal of this clinical research study is to learn if Actonel (risedronate) can help to prevent the development of osteoporosis (brittle and weak bones) caused by the steroid medication used to treat leukemia. The safety of this treatment in patients with ALL or LL will also be studied.
NCT00453492 Risedronate Sodium in Post Menopausal Osteoporosis Completed Procter and Gamble Phase 4 2004-01-01 The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women. The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)].
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Risedronate Sodium

Condition Name

Condition Name for Risedronate Sodium
Intervention Trials
Osteoporosis, Postmenopausal 2
Osteoporosis 2
Colles' Fracture 1
Breast Cancer 1
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Condition MeSH

Condition MeSH for Risedronate Sodium
Intervention Trials
Osteoporosis 5
Osteoporosis, Postmenopausal 2
Fractures, Bone 2
Precursor Cell Lymphoblastic Leukemia-Lymphoma 1
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Clinical Trial Locations for Risedronate Sodium

Trials by Country

Trials by Country for Risedronate Sodium
Location Trials
United States 9
Japan 4
United Kingdom 2
Greece 1
Spain 1
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Trials by US State

Trials by US State for Risedronate Sodium
Location Trials
Texas 2
Pennsylvania 1
Ohio 1
North Carolina 1
New York 1
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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 4
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Risedronate Sodium
Clinical Trial Phase Trials
Completed 7
Active, not recruiting 2
Recruiting 1
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Clinical Trial Sponsors for Risedronate Sodium

Sponsor Name

Sponsor Name for Risedronate Sodium
Sponsor Trials
Takeda 3
Sanofi 3
Procter and Gamble 3
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Sponsor Type

Sponsor Type for Risedronate Sodium
Sponsor Trials
Industry 11
Other 2
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