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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR ROCALTROL

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Clinical Trials for Rocaltrol

Trial ID Title Status Sponsor Phase Summary
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.
NCT00427037 Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects Completed Atlanta VA Medical Center N/A This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of the subjects will be randomized to vitamin D3 and the other half will receive a placebo. Subjects will be referred from the nutrition or renal clinic at Emory. CKD stage 3 and 4 patients will be eligible for participation if they have been determined to have vitamin D deficiency and are not on treatment with vitamin D or vitamin D analogues. Subjects will sign an informed consent form after reviewing the protocol in detail with the principal investigator. A questionnaire would collect information about dietary vitamin D intake, sunlight exposure, and any symptoms of vitamin D deficiency. The subject will have baseline levels of serum vitamin D (25-hydroxyvitamin D), parathyroid hormone (PTH), serum calcium and phosphate, creatinine and other markers of bone turnover. The questionnaires and the blood draws would be repeated on the 6th and 12th week of the study. Subjects will be given 12 pills of each containing either 50,000 IU vitamin D or placebo and asked to take one pill a week. They would be scheduled to return to the clinic after 6 weeks and blood measurements would be repeated. Subjects will be asked to revisit for their final visit at the 12th week when they would have their last blood draw and assessment.
NCT00560300 Regulation of Bone Formation in Renal Osteodystrophy Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Rocaltrol

Condition Name

Condition Name for Rocaltrol
Intervention Trials
Vitamin D Deficiency 2
Chronic Kidney Disease 2
Secondary Hyperparathyroidism 2
Facial Angiofibroma 1
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Condition MeSH

Condition MeSH for Rocaltrol
Intervention Trials
Hyperparathyroidism 4
Renal Insufficiency, Chronic 4
Kidney Diseases 4
Hyperparathyroidism, Secondary 3
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Clinical Trial Locations for Rocaltrol

Trials by Country

Trials by Country for Rocaltrol
Location Trials
United States 7
China 2
Switzerland 1
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Trials by US State

Trials by US State for Rocaltrol
Location Trials
New York 2
Minnesota 1
Alabama 1
California 1
Missouri 1
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Clinical Trial Progress for Rocaltrol

Clinical Trial Phase

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

Clinical Trial Status for Rocaltrol
Clinical Trial Phase Trials
Completed 10
Enrolling by invitation 1
Not yet recruiting 1
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Clinical Trial Sponsors for Rocaltrol

Sponsor Name

Sponsor Name for Rocaltrol
Sponsor Trials
Columbia University 2
University Hospital, Geneva 1
Roxane Laboratories 1
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Sponsor Type

Sponsor Type for Rocaltrol
Sponsor Trials
Other 11
Industry 4
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Julphar
Cerilliant
Moodys
Colorcon
Teva
AstraZeneca
Cantor Fitzgerald
Queensland Health

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