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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR CALCITRIOL

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505(b)(2) Clinical Trials for Calcitriol

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 NCT00055263 A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies Completed Novacea Phase 1 2002-03-01 The purposes of this study are to: - Test the safety of DN-101 in patients with advanced malignancies - Understand how fast the body absorbs, processes, and eliminates DN-101 - Determine the highest dose of DN-101 that is well tolerated by cancer patients - Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Calcitriol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000412 Osteoporosis Prevention After Heart Transplant Completed Merck Sharp & Dohme Corp. Phase 3 1997-09-01 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 1997-09-01 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 1997-09-01 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.
NCT00001304 Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1991-10-01 This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.
NCT00001416 Bone Response to Enzyme Replacement in Gaucher's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 1993-12-01 The purpose of this study is to examine how the skeleton responds to repeated doses of enzyme replacement therapy in patients with type I Gaucher's disease who have had their spleens removed. Gaucher disease is a lysosomal storage disease resulting from glycocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in adults but occurs most severely in infants, in whom cerebroside also accumulates in neurons. Patients with Gaucher's disease experience enlargement of the liver and spleen and bone destruction. The condition is passed from generation to generation through autosomal recessive inheritance. Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease does not affect nerve cells. The symptoms of type I can appear at any age. In this study patients will be divided into three groups. Each group will receive different doses of enzyme replacement (Ceredase). In addition, two of the three groups will also receive doses of a form of vitamin D (calcitriol). Researchers believe the groups receiving vitamin D will have an improved response as compared to those patients only receiving enzyme replacement. Patients in each group who respond to enzyme replacement with increases in bone density will be compared to the other treatment groups.
NCT00004340 Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 1995-06-01 OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy. II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.
NCT00004340 Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis Completed University of California, Los Angeles Phase 2 1995-06-01 OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy. II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Calcitriol

Condition Name

Condition Name for Calcitriol
Intervention Trials
Prostate Cancer 10
Vitamin D Deficiency 8
Secondary Hyperparathyroidism 8
Chronic Kidney Disease 7
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Condition MeSH

Condition MeSH for Calcitriol
Intervention Trials
Kidney Diseases 26
Renal Insufficiency, Chronic 18
Prostatic Neoplasms 15
Hyperparathyroidism 14
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Clinical Trial Locations for Calcitriol

Trials by Country

Trials by Country for Calcitriol
Location Trials
United States 236
Canada 24
Italy 7
Malaysia 7
China 6
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Trials by US State

Trials by US State for Calcitriol
Location Trials
New York 31
California 16
Texas 14
Oregon 10
Pennsylvania 10
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Clinical Trial Progress for Calcitriol

Clinical Trial Phase

Clinical Trial Phase for Calcitriol
Clinical Trial Phase Trials
Phase 4 35
Phase 3 15
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Calcitriol
Clinical Trial Phase Trials
Completed 77
Unknown status 17
Terminated 15
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Clinical Trial Sponsors for Calcitriol

Sponsor Name

Sponsor Name for Calcitriol
Sponsor Trials
National Cancer Institute (NCI) 12
Roswell Park Cancer Institute 8
Novacea 8
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Sponsor Type

Sponsor Type for Calcitriol
Sponsor Trials
Other 134
Industry 46
NIH 30
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