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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR AREDIA

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Clinical Trials for Aredia

Trial ID Title Status Sponsor Phase Summary
NCT00062595 Vitamin K and Bone Turnover in Postmenopausal Women Completed Eisai Co., Ltd. Phase 3 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 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.
NCT00311571 Toulouse Male Long Term Bed Rest 2001-2002 Completed European Space Agency Phase 1 Microgravity during space flight induces physiological changes that affect astronauts’ health and performance. Space flight simulations such as prolonged bed rest can mimic some of these changes and provide study conditions that are more accessible than during space flight. The European Space Agency, ESA together with the French national space agency, CNES and the Japanese national space agency, NASDA are performing extensive studies using long duration bed rest. Previous studies including several long and short term bed rest campaigns have yielded significant medical data on the physiological changes induced by space flight. These data can be used to study the effect of countermeasures, methods helping to prevent these physiological changes. The long duration bed rest, lasting 3 months undertakes a variety of investigations involving 28 subjects. This study focuses on countermeasures, studying the effect of a bone tissue stabilisation medication and resistive exercises to determine their suitability for use during long duration stays on ISS. The physiological changes recorded during space flight and bed rest mimic those observed in some diseases and in the aging process. Significant clinical applications are expected as a direct result of this experiment and future equivalent studies.
NCT00311571 Toulouse Male Long Term Bed Rest 2001-2002 Completed National Space Development Agency, Japan Phase 1 Microgravity during space flight induces physiological changes that affect astronauts’ health and performance. Space flight simulations such as prolonged bed rest can mimic some of these changes and provide study conditions that are more accessible than during space flight. The European Space Agency, ESA together with the French national space agency, CNES and the Japanese national space agency, NASDA are performing extensive studies using long duration bed rest. Previous studies including several long and short term bed rest campaigns have yielded significant medical data on the physiological changes induced by space flight. These data can be used to study the effect of countermeasures, methods helping to prevent these physiological changes. The long duration bed rest, lasting 3 months undertakes a variety of investigations involving 28 subjects. This study focuses on countermeasures, studying the effect of a bone tissue stabilisation medication and resistive exercises to determine their suitability for use during long duration stays on ISS. The physiological changes recorded during space flight and bed rest mimic those observed in some diseases and in the aging process. Significant clinical applications are expected as a direct result of this experiment and future equivalent studies.
NCT00311571 Toulouse Male Long Term Bed Rest 2001-2002 Completed Centre National d'Etudes Spatiales Phase 1 Microgravity during space flight induces physiological changes that affect astronauts’ health and performance. Space flight simulations such as prolonged bed rest can mimic some of these changes and provide study conditions that are more accessible than during space flight. The European Space Agency, ESA together with the French national space agency, CNES and the Japanese national space agency, NASDA are performing extensive studies using long duration bed rest. Previous studies including several long and short term bed rest campaigns have yielded significant medical data on the physiological changes induced by space flight. These data can be used to study the effect of countermeasures, methods helping to prevent these physiological changes. The long duration bed rest, lasting 3 months undertakes a variety of investigations involving 28 subjects. This study focuses on countermeasures, studying the effect of a bone tissue stabilisation medication and resistive exercises to determine their suitability for use during long duration stays on ISS. The physiological changes recorded during space flight and bed rest mimic those observed in some diseases and in the aging process. Significant clinical applications are expected as a direct result of this experiment and future equivalent studies.
NCT00482378 Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain Active, not recruiting National Cancer Institute (NCI) Phase 1/Phase 2 RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma. PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain.
NCT00482378 Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain Active, not recruiting Mayo Clinic Phase 1/Phase 2 RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma. PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aredia

Condition Name

Condition Name for Aredia
Intervention Trials
Osteoporosis 3
Breast Cancer 3
Osteopenia 2
Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest 1
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Condition MeSH

Condition MeSH for Aredia
Intervention Trials
Bone Diseases, Metabolic 3
Osteoporosis 3
Breast Neoplasms 2
Bone Diseases 2
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Clinical Trial Locations for Aredia

Trials by Country

Trials by Country for Aredia
Location Trials
United States 7
Canada 1
Spain 1
France 1
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Trials by US State

Trials by US State for Aredia
Location Trials
Minnesota 2
Washington 1
Texas 1
Pennsylvania 1
New Mexico 1
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Clinical Trial Progress for Aredia

Clinical Trial Phase

Clinical Trial Phase for Aredia
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Aredia
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Aredia

Sponsor Name

Sponsor Name for Aredia
Sponsor Trials
Novartis 2
Mayo Clinic 1
AstraZeneca 1
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Sponsor Type

Sponsor Type for Aredia
Sponsor Trials
Other 11
Industry 6
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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UBS
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