CLINICAL TRIALS PROFILE FOR ROCALTROL

All Clinical Trials for ROCALTROL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	Roswell Park Cancer Institute	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00427037 ↗	Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects	Completed	Atlanta VA Medical Center	N/A	2005-12-01	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	2000-11-01	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
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.

Clinical Trial Conditions for ROCALTROL

Condition Name

Condition Name for ROCALTROL
Intervention	Trials
Vitamin D Deficiency	4
Chronic Kidney Disease	4
Secondary Hyperparathyroidism	3
Hypocalcemia	2

Condition MeSH

Condition MeSH for ROCALTROL
Intervention	Trials
Kidney Diseases	8
Renal Insufficiency, Chronic	7
Hyperparathyroidism	5
Hyperparathyroidism, Secondary	4

Clinical Trial Locations for ROCALTROL

Trials by Country

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Trials by Country for ROCALTROL
Location	Trials
United States	34
China	5
Brazil	1
Netherlands	1
Chile	1

Trials by US State

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Trials by US State for ROCALTROL
Location	Trials
New York	5
Minnesota	2
Alabama	2
Virginia	2
California	2

Clinical Trial Progress for ROCALTROL

Clinical Trial Phase

Clinical Trial Phase for ROCALTROL
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	3
Phase 2	4

Clinical Trial Status

Clinical Trial Status for ROCALTROL
Clinical Trial Phase	Trials
Completed	16
Terminated	4
Not yet recruiting	2

Clinical Trial Sponsors for ROCALTROL

Sponsor Name

Sponsor Name for ROCALTROL
Sponsor	Trials
Columbia University	2
National Cancer Institute (NCI)	2
Roswell Park Cancer Institute	2

Sponsor Type

Sponsor Type for ROCALTROL
Sponsor	Trials
Other	36
Industry	6
NIH	4

Rocaltrol (Calcitriol): Clinical Trials, Market Analysis, and Projections

Introduction to Rocaltrol (Calcitriol)

Rocaltrol, known generically as calcitriol, is the hormonally active metabolite of vitamin D. It plays a crucial role in regulating calcium and phosphate levels in the body, making it a vital treatment for various medical conditions, including osteoporosis, chronic kidney disease (CKD), and certain types of cancer.

Clinical Trials and Antineoplastic Activity

Current Trials and Studies

Calcitriol is currently under investigation in several clinical trials for its potential in treating various types of cancer. A notable study involves the combination of high-dose calcitriol with docetaxel, which has shown encouraging results in patients with androgen-independent prostate cancer. This regimen is now being studied in a placebo-controlled randomized trial and in phase II studies for other tumor types[1].

Antineoplastic Mechanisms

The antineoplastic activity of calcitriol has been demonstrated in preclinical models of several cancers, including carcinoma of the bladder, breast, colon, endometrium, kidney, lung, pancreas, prostate, sarcomas, neuroblastoma, glioma, melanoma, and squamous cell carcinoma. Calcitriol's mechanisms of action include inhibition of proliferation, cell cycle arrest, induction of apoptosis, and reduction of invasiveness and angiogenesis[1][4].

Market Analysis

Global Market Size and Growth

The global calcitriol market was valued at approximately USD 441.62 million in 2023 and is projected to grow to around USD 608.42 million by 2032, with a compound annual growth rate (CAGR) of 3.3% during the forecast period (2024-2032)[2].

Another report estimates the market size to be around USD 442.53 million in 2023, projected to grow to USD 679.49 million by 2032, with a CAGR of 4.88%[5].

Market Drivers

The growth of the calcitriol market is driven by several factors:

• Increasing Prevalence of Chronic Diseases: The rising incidence of osteoporosis and chronic kidney disease, particularly among the elderly population, is a significant driver[2][3][5].
• Growing Awareness and Personalized Therapies: Increasing awareness about vitamin D deficiency and the potential for personalized vitamin D therapies using calcitriol are enhancing market potential[2][3].
• Advancements in Drug Delivery: Novel drug delivery systems, such as sustained-release formulations and high-concentration injections, are improving patient compliance and bioavailability[3].

Market Segments

• Product Types: The market is segmented into oral solutions and injections, with the injectable segment anticipated to hold the largest market share due to ease of administration and better bioavailability[3].
• Distribution Channels: Hospital pharmacies dominate the distribution channel segment due to the availability of a wide range of calcitriol products and the presence of trained healthcare professionals[2][3].
• Geographical Regions: North America is the largest market shareholder, driven by an aging population and advanced healthcare infrastructure. The Asia-Pacific region is also a pivotal market, driven by increasing awareness and healthcare expenditure[2][3].

Market Projections

Regional Growth

• North America: Expected to expand substantially due to the high prevalence of CKD and osteoporosis, well-established healthcare infrastructure, and significant investment in R&D[2][3].
• Asia-Pacific: Rapidly developing, driven by rising incomes and an increasing upper class prioritizing health in countries like China and India[2].

Emerging Trends

• Personalized Medicine: There is a growing focus on personalized dosing and tailored therapies to optimize treatment outcomes[3].
• Technological Advancements: Integration of artificial intelligence in drug development and novel vitamin D analogs are expected to expand the market[3].

Challenges and Restraints

• Regulatory Requirements: Stringent regulatory guidelines impact product development and approval timelines, requiring rigorous quality control measures[2][3].
• Limited Reimbursement: Limited reimbursement and insurance coverage can hinder market growth[3].

Key Takeaways

• Clinical Trials: Calcitriol is being studied for its antineoplastic activity in various cancers, with promising results in combination therapies.
• Market Growth: The global calcitriol market is expected to grow significantly, driven by the increasing prevalence of chronic diseases and advancements in drug delivery.
• Regional Dominance: North America and the Asia-Pacific region are key markets, with North America leading due to its advanced healthcare infrastructure.
• Emerging Trends: Personalized medicine and technological advancements are expected to drive future market growth.

FAQs

What is the primary use of calcitriol in clinical settings?

Calcitriol is primarily used to regulate calcium and phosphate levels, particularly in patients with osteoporosis and chronic kidney disease.

What are the potential antineoplastic applications of calcitriol?

Calcitriol has shown antineoplastic activity in preclinical models of various cancers, including prostate, breast, colon, and others, through mechanisms such as inhibition of proliferation and induction of apoptosis.

Which region is expected to dominate the calcitriol market?

North America is expected to dominate the calcitriol market due to its high prevalence of CKD and osteoporosis, along with its well-established healthcare infrastructure.

What are the key drivers of the calcitriol market growth?

The key drivers include the increasing prevalence of chronic diseases, growing awareness of vitamin D deficiency, and advancements in drug delivery systems.

What are the challenges facing the calcitriol market?

Challenges include stringent regulatory requirements, limited reimbursement and insurance coverage, and potential side effects and drug interactions.

Sources

1. AACR Journals: "Calcitriol in cancer treatment: From the lab to the clinic"[1]
2. Straits Research: "Global Calcitriol Market Size to Grow at a CAGR of 3.3% by 2032"[2]
3. Data Insights Market: "Calcitriol Drug Charting Growth Trajectories: Analysis and Forecasts"[3]
4. Aetna: "Calcitriol, Etelcalcetide, and Paricalcitol Injections"[4]
5. Zion Market Research: "Calcitriol Market Size, Share, Growth and Forecast 2024 - 2032"[5]