CLINICAL TRIALS PROFILE FOR ROCALTROL

All Clinical Trials for Rocaltrol

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.
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.
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.

Clinical Trial Conditions for Rocaltrol

Condition Name

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

Condition MeSH

Condition MeSH for Rocaltrol
Intervention	Trials
Kidney Diseases	8
Renal Insufficiency, Chronic	7
Hyperparathyroidism	5
Vitamin D Deficiency	4

Clinical Trial Locations for Rocaltrol

Trials by Country

Trials by Country for Rocaltrol
Location	Trials
United States	34
China	5
Denmark	1
Italy	1
Spain	1

Trials by US State

Trials by US State for Rocaltrol
Location	Trials
New York	5
Missouri	2
Utah	2
Minnesota	2
Alabama	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
Active, not 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

Clinical Trials Update, Market Analysis, and Projection for Rocaltrol (Calcitriol)

Last updated: October 30, 2025

Introduction

Rocaltrol, the brand name for calcitriol, is a synthetic form of active vitamin D3. Primarily used for managing secondary hyperparathyroidism in chronic kidney disease (CKD) and aiding calcium regulation in osteoporosis, Rocaltrol’s pharmacological profile positions it at the intersection of nephrology, endocrinology, and metabolic bone disease treatment. This comprehensive analysis explores recent clinical trials, evaluates its current market landscape, and projects future industry trajectories.

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Clinical Trials Landscape for Rocaltrol

Recent Clinical Trials and Findings

Recent clinical investigations focus on expanding Rocaltrol’s therapeutic scope and optimizing its safety profile:

• CKD-Related Hyperparathyroidism: Numerous Phase II and III trials have corroborated calcitriol’s efficacy in lowering parathyroid hormone (PTH) levels among CKD patients. A notable study published in Nephrology Dialysis Transplantation (2022) confirmed that personalized dosing strategies reduce PTH without precipitating hypercalcemia[^1].

• Osteoporosis and Mineral Metabolism: Trials exploring calcitriol’s role in postmenopausal osteoporosis demonstrate improved bone mineral density (BMD) and reduced fracture risk when combined with other agents like bisphosphonates. A 2021 randomized control trial suggested that calcitriol enhances calcium absorption, supporting bone health[^2].

• COVID-19 and Immune Response: Emerging interest surrounds calcitriol's immunomodulatory effects. A 2022 observational trial indicated potential benefits in reducing severity of COVID-19 in vitamin D-deficient populations, though definitive claims await larger, randomized studies[^3].

• Novel Delivery Systems: Trials are also evaluating innovative formulations, including slow-release and nanoformulations, aiming to improve gel-based bioavailability and reduce dosing frequency, thus enhancing patient compliance.

Regulatory and Ongoing Trials

While Rocaltrol itself has a well-established regulatory status, trials evaluating biosimilars and generics continue to refine its market position. The FDA and EMA support ongoing studies to assess long-term safety, especially in pediatric and geriatric populations, ensuring broader safety profiles.

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Market Analysis

Current Market Dynamics

The global vitamin D analog market, estimated at USD 400 million in 2022, includes key competitors like paricalcitol and doxercalciferol. Rocaltrol commands a significant portion due to its early market entry, established clinical efficacy, and approved indications.

• Geographical Insights: North America remains the dominant region, accounting for approximately 45% of sales, propelled by high CKD prevalence and advanced healthcare infrastructure[^4]. Europe follows, with increasing adoption driven by aging populations and osteoporosis management needs. In Asia-Pacific, rapid demographic shifts toward older populations bolster demand, despite regional pricing pressures.

• Market Drivers: The rise in CKD prevalence—projected to affect 10% of the global population—fuels demand for calcitriol-based therapies. Moreover, expanding use in osteoporosis, especially among postmenopausal women, sustains growth. Complementing this, increased awareness of vitamin D’s broader health benefits and expanding clinical evidence bolster market expansion.

• Pricing and Reimbursement Factors: Rocaltrol benefits from established reimbursement pathways in major markets but faces pricing pressures due to the emergence of generics. Patent expiry, notably in 2017 in the US and Europe, led to a market shift favoring lower-cost alternatives.

Market Challenges

• Safety Concerns: Hypercalcemia and hyperphosphatemia risks necessitate careful dosage and monitoring, which can limit widespread use in certain populations.
• Competition from Biosimilars and Alternatives: Newer vitamin D analogs with improved safety profiles and targeted delivery systems threaten Rocaltrol’s market share.
• Regulatory Hurdles: Stricter safety and efficacy standards may impede rapid approvals of novel formulations.

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Future Market Projection

Growth Forecasts

Analysts project a compounded annual growth rate (CAGR) of approximately 4-5% for the Rocaltrol market through 2030, driven by:

• Growing CKD and Osteoporosis Patient Base: Estimated to ascend by 7% annually, particularly in aging societies.
• Innovation in Formulations: Slow-release and targeted delivery systems are expected to reduce side effects, expand usage, and improve compliance.
• Emerging Applications: Investigational uses, especially in immune modulation and infectious diseases, may broaden Rocaltrol’s therapeutic portfolio.

Strategic Opportunities

• Personalized Medicine: Tailoring dosages based on genetic and metabolic profiles could optimize outcomes.
• Combination Therapies: Co-administration with other osteoporosis or CKD medications can enhance efficacy and reduce adverse events.
• Market Expansion: Focused efforts in underserved regions, including Latin America and Africa, could compensate for stagnation in mature markets.

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Conclusion

Rocaltrol remains an integral agent within vitamin D analog therapies, supported by decades of clinical experience. Ongoing research aims to refine its safety, expand indications, and leverage innovative delivery methods. Market growth is sustained by the rising prevalence of CKD and osteoporosis; however, competition and safety concerns necessitate continuous innovation and strategic positioning.

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Key Takeaways

• Recent clinical trials reaffirm Rocaltrol’s efficacy in managing secondary hyperparathyroidism and osteoporosis, with ongoing investigations into broader applications.
• The global Rocaltrol market, valued at around USD 400 million in 2022, is expected to grow at a CAGR of 4-5% through 2030, driven by demographic shifts and increasing chronic disease prevalence.
• Patent expirations have led to increased generic competition, emphasizing the importance of innovative formulations and personalized treatment approaches.
• Safety remains a critical factor; future developments aim to mitigate hypercalcemia risks and improve patient adherence.
• Expanding into emerging markets offers significant growth potential, especially with tailored healthcare strategies and regulatory adaptations.

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FAQs

1. What are the primary medical indications for Rocaltrol?
Rocaltrol is mainly prescribed for secondary hyperparathyroidism in chronic kidney disease and calcium regulation in osteoporosis.

2. How does Rocaltrol compare to other vitamin D analogs?
While offering proven efficacy, Rocaltrol may have a higher risk of hypercalcemia compared to newer analogs like paricalcitol, prompting clinicians to weigh benefits against safety profiles.

3. Are there ongoing efforts to develop new formulations of Rocaltrol?
Yes, research into slow-release and nanoformulations aims to enhance bioavailability and minimize adverse effects.

4. What is the outlook for Rocaltrol in emerging markets?
Growing prevalence of CKD and osteoporosis, coupled with expanding healthcare infrastructure, suggests a promising growth trajectory in regions like Asia-Pacific, Latin America, and Africa.

5. What are key safety considerations when prescribing Rocaltrol?
Monitoring calcium and phosphate levels is essential to prevent hypercalcemia and related complications, especially in patients with compromised renal function.

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References

[^1]: Nephrology Dialysis Transplantation, 2022. "Personalized Dosing Strategies for Calcitriol in CKD Patients."
[^2]: Journal of Bone and Mineral Research, 2021. "Combination Therapy with Calcitriol in Postmenopausal Osteoporosis."
[^3]: International Journal of Infectious Diseases, 2022. "Immunomodulatory Effects of Calcitriol in COVID-19 Patients."
[^4]: MarketsandMarkets, 2022. "Vitamin D Analog Market Forecast."