ROCALTROL SUMMARY
ROCALTROL®
brand of(calcitriol)
CAPSULES and ORAL SOLUTION
Rx Only
Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Rocaltrol is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/mL of calcitriol.
Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of >/= 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.
Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.
Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
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NEWS HIGHLIGHTS
Published Studies Related to Rocaltrol (Calcitriol)
Intravenous calcitriol versus paricalcitol in haemodialysis patients with severe secondary hyperparathyroidism. [2009.08]
AIM: Secondary hyperparathyroidism (SHPT) is common among haemodialysis patients. Intensive treatment with calcitriol is often complicated by hypercalcaemia, hyperphosphataemia and elevated calcium phosphorus (Ca X PO(4)) product. Paricalcitol is a vitamin D analogue developed to overcome some of the limitations of calcitriol therapy. The study objectives were to compare the response of intact parathyroid hormone (iPTH) and the incidence of hypercalcaemia, hyperphosphataemia and elevated Ca X PO(4) product in patients with severe SHPT treated with either i.v. calcitriol or i.v. paricalcitol... CONCLUSION: Intravenous paricalcitol may be superior to i.v. calcitriol for the treatment of severe SHPT in our chronic haemodialysis population. A larger randomized controlled trial is indicated to confirm these initial findings.
Comparison of oral falecalcitriol and intravenous calcitriol in hemodialysis patients with secondary hyperparathyroidism: a randomized, crossover trial. [2009.06]
BACKGROUND: Falecalcitriol is a novel vitamin D analog, which has a greater potential to suppress parathyroid hormone (PTH) and a longer half-life. There are few studies to compare clinical effects of oral falecalcitriol treatment with those of intravenous calcitriol treatment... CONCLUSION: The present study showed that oral falecalcitriol treatment is effective for PTH suppression, and Ca and P metabolism in hemodialysis patients with moderate to severe SHPT, as well as intravenous calcitriol administration.
Comparison of intermittent intravenous and oral calcitriol in the treatment of secondary hyperparathyroidism in chronic hemodialysis patients: a meta-analysis of randomized controlled trials. [2009.03]
BACKGROUND: Controversy exists regarding the optimal route and mode of calcitriol administration in the treatment of secondary hyperparathyroidism (SHPT). The aim of this study is to compare the efficacy and adverse reaction of calcitriol in the same mode (intermittent) but different route (intravenous versus oral) in the treatment of SHPT... CONCLUSIONS: Our analysis indicated that there were no significant differences between intermittent intravenous and oral calcitriol in the treatment of SHPT, both in their efficacy and adverse reaction. Since the present studies had several limitations in methodological design and sample size, largescale and long-term comparisons of intermittent intravenous and oral treatment need to be done in a randomized, double-blind, placebo-controlled design to accurately evaluate their relative efficacy and safety.
The efficacy and safety of calcitriol and/or Caltrate D in elderly Chinese women with low bone mass. [2009.03]
AIM: To observe the efficacy and safety of Rocaltrol (calcitriol) and/or Caltrate D (calicum carbonate plus vitamin D) in elderly Chinese women with osteopenia or osteoporosis... CONCLUSION: Treatment with Rocaltrol plus Caltrate D or Caltrate D for 12 months in elderly Chinese postmenopausal women effectively increased BMD at the lumbar spine. Rocaltrol plus Caltrate D was more effective at the lumbar spine than Caltrate D alone.
Calcium balance during calcitriol and paricalcitol administration in healthy humans. [2008.03]
OBJECTIVE: Secondary hyperparathyroidism in hemodialysis patients requires optimal correction of vitamin D deficiency with active vitamin D and analogues. It has been postulated that new vitamin D analogues, i.e. paricalcitol, efficiently suppress parathyroid hormone serum levels (PTH), but do not increase intestinal calcium absorption as much as calcitriol. The effects of calcitriol and paricalcitol on calcium balance can best be characterized under standardized conditions in healthy individuals with normal renal function, because the urinary calcium excretion at steady state corresponds to the net calcium absorption in the gut... CONCLUSION: Using a dosing ratio of 1:3 for calcitriol:paricalcitol, i.e. the same conversion factor used previously in studies on hemodialysis patients, only calcitriol was able to reduce iPTH levels in healthy individuals. Low-dose calcitriol reduced iPTH levels without raising calcium absorption and without including any hypercalcemia.
Clinical Trials Related to Rocaltrol (Calcitriol)
Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004 [Active, not recruiting]
Study of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome (MDS) [Active, not recruiting]
The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in
patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.
Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer [Completed]
This Phase 1/2 clinical trial is a multi-center, open-label study with three main objectives.
The first (Phase 1A) is to determine the maximum-tolerated dose of DN-101 when administered
in combination with Taxotere (docetaxel) every three weeks (closed). The second is to
determine the maximum-tolerated dose of DN-101 when administered weekly in combination with
Taxotere(docetaxel)devery three weeks (open). The third is to evaluate the safety and
objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at
three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous
docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose
level each 21 days until disease progression or unacceptable toxicity.
A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies [Completed]
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
Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid Tumors [Completed]
RATIONALE: Calcitriol may cause solid tumor cells to look more like normal cells, and to grow
and spread more slowly. Ketoconazole and dexamethasone may help calcitriol work better by
making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole
and dexamethasone may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when
given together with ketoconazole and dexamethasone in treating patients with metastatic or
unresectable solid tumors.
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