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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR FORTEO

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Clinical Trials for Forteo

Trial ID Title Status Sponsor Phase Summary
NCT00005006 Parathyroid Hormone (PTH) With Alendronate for Osteoporosis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00005006 Parathyroid Hormone (PTH) With Alendronate for Osteoporosis Completed Helen Hayes Hospital Phase 2 This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00051558 Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis Completed Eli Lilly and Company Phase 3 Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
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.
NCT00131469 Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta Completed Eli Lilly and Company Phase 4 The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI).
NCT00131469 Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta Completed National Center for Research Resources (NCRR) Phase 4 The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Forteo

Condition Name

Condition Name for Forteo
Intervention Trials
Osteoporosis 38
Postmenopausal Osteoporosis 5
Bone Loss 4
Spinal Cord Injury 3
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Condition MeSH

Condition MeSH for Forteo
Intervention Trials
Osteoporosis 50
Osteoporosis, Postmenopausal 10
Fractures, Bone 9
Hip Fractures 4
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Clinical Trial Locations for Forteo

Trials by Country

Trials by Country for Forteo
Location Trials
United States 176
Canada 25
Argentina 9
Spain 9
Australia 8
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Trials by US State

Trials by US State for Forteo
Location Trials
New York 12
Colorado 10
California 10
Nebraska 9
Georgia 8
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Clinical Trial Progress for Forteo

Clinical Trial Phase

Clinical Trial Phase for Forteo
Clinical Trial Phase Trials
Phase 4 21
Phase 3 15
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Forteo
Clinical Trial Phase Trials
Completed 42
Active, not recruiting 8
Terminated 4
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Clinical Trial Sponsors for Forteo

Sponsor Name

Sponsor Name for Forteo
Sponsor Trials
Eli Lilly and Company 33
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 4
Novartis Pharmaceuticals 2
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Sponsor Type

Sponsor Type for Forteo
Sponsor Trials
Industry 49
Other 47
NIH 8
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