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Rocaltrol (Calcitriol) - Summary

 

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ROCALTROL SUMMARY

ROCALTROL®
brand of
calcitriol
CAPSULES and ORAL SOLUTION

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.

ROCALTROL NEWS HIGHLIGHTS

Published Studies Related to Rocaltrol (Calcitriol)

Calcium balance during calcitriol and paricalcitol administration in healthy humans. [2008.03]

Intermittent chemotherapy in patients with metastatic androgen-independent prostate cancer: results from ASCENT, a double-blinded, randomized comparison of high-dose calcitriol plus docetaxel with placebo plus docetaxel. [2008.01.15]

Oral calcitriol versus oral alfacalcidol for the treatment of secondary hyperparathyroidism in patients receiving hemodialysis: a randomized, crossover trial. [2008.01]

Comparison of cutaneous tolerance and efficacy of calcitriol 3 mug g(-1) ointment and tacrolimus 0.3 mg g(-1) ointment in chronic plaque psoriasis involving facial or genitofemoral areas: a double-blind, randomized controlled trial. [2007.11]

Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: a report from the ASCENT Investigators. [2007.02.20]

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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]

Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer [Completed]

A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies [Completed]

Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid Tumors [Completed]

more>>

Page last updated: 2008-06-22

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