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Last Updated: September 26, 2021

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CLINICAL TRIALS PROFILE FOR ACTONEL

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505(b)(2) Clinical Trials for Actonel

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 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.
NCT00062595 ↗ Vitamin K and Bone Turnover in Postmenopausal Women Completed Eisai Co., Ltd. Phase 3 2000-09-01 This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.
NCT00062595 ↗ Vitamin K and Bone Turnover in Postmenopausal Women Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 2000-09-01 This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Actonel

Condition Name

Condition Name for Actonel
Intervention Trials
Osteoporosis 12
Osteoporosis, Postmenopausal 5
Breast Cancer 3
Bone Loss 3
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Condition MeSH

Condition MeSH for Actonel
Intervention Trials
Osteoporosis 18
Osteoporosis, Postmenopausal 6
Breast Neoplasms 3
Bone Diseases, Metabolic 3
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Clinical Trial Locations for Actonel

Trials by Country

Trials by Country for Actonel
Location Trials
United States 70
Canada 13
Australia 5
United Kingdom 4
Spain 4
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Trials by US State

Trials by US State for Actonel
Location Trials
North Carolina 4
Florida 4
Pennsylvania 4
Ohio 4
Massachusetts 4
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Clinical Trial Progress for Actonel

Clinical Trial Phase

Clinical Trial Phase for Actonel
Clinical Trial Phase Trials
Phase 4 15
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Actonel
Clinical Trial Phase Trials
Completed 24
Recruiting 4
Unknown status 2
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Clinical Trial Sponsors for Actonel

Sponsor Name

Sponsor Name for Actonel
Sponsor Trials
Sanofi 10
Procter and Gamble 9
Alliance for Better Bone Health 2
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Sponsor Type

Sponsor Type for Actonel
Sponsor Trials
Other 28
Industry 26
NIH 4
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