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Generated: March 18, 2019

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CLINICAL TRIALS PROFILE FOR FOSAMAX

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Clinical Trials for Fosamax

Trial ID Title Status Sponsor Phase Summary
NCT00000400 Alendronate and/or Parathyroid Hormone for Osteoporosis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
NCT00000400 Alendronate and/or Parathyroid Hormone for Osteoporosis Completed Massachusetts General Hospital Phase 2 This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
NCT00000412 Osteoporosis Prevention After Heart Transplant Completed Merck Sharp & Dohme Corp. Phase 3 During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 Osteoporosis Prevention After Heart Transplant Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 3 During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 Osteoporosis Prevention After Heart Transplant Completed Columbia University Phase 3 During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00001720 Treatment of Childhood Osteoporosis With Alendronate (Fosamax) Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 Bones grow and stay strong through a continuous process of formation (building) and resorption (break down). When more bone is formed than resorbed, the density (level of calcium) in bone increases and the bones become stronger. However, if more bone is resorbed than formed the density of bone decreases and the bones become weak. This condition is called osteoporosis. Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer from pain, inability to stay active, and increased amounts of broken bones, including fractures of the spine. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition (peak bone mass) during the first 20-30 years of life may be at an increased risk for osteoporosis as adults. Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has been used to treat post-menopausal osteoporosis, male osteoporosis and adults with osteoporosis due to long-term steroid therapy. The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis.
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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fosamax

Condition Name

Condition Name for Fosamax
Intervention Trials
Osteoporosis 29
Healthy 4
Osteoporosis, Postmenopausal 2
Osteopenia 2
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Condition MeSH

Condition MeSH for Fosamax
Intervention Trials
Osteoporosis 35
Osteoporosis, Postmenopausal 6
Bone Diseases, Metabolic 5
Bone Diseases 2
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Clinical Trial Locations for Fosamax

Trials by Country

Trials by Country for Fosamax
Location Trials
United States 24
Canada 4
China 2
Hong Kong 2
Spain 1
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Trials by US State

Trials by US State for Fosamax
Location Trials
New York 5
South Carolina 3
Massachusetts 3
North Dakota 2
California 2
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Clinical Trial Progress for Fosamax

Clinical Trial Phase

Clinical Trial Phase for Fosamax
Clinical Trial Phase Trials
Phase 4 15
Phase 3 10
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Fosamax
Clinical Trial Phase Trials
Completed 32
Unknown status 7
Recruiting 4
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Clinical Trial Sponsors for Fosamax

Sponsor Name

Sponsor Name for Fosamax
Sponsor Trials
Merck Sharp & Dohme Corp. 12
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 4
Columbia University 3
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Sponsor Type

Sponsor Type for Fosamax
Sponsor Trials
Other 56
Industry 24
NIH 10
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