Clodromax

Many countries, since 1988, have been using Clodronate to help stop cancer from spreading to the bone which is usually associated with breast, prostate, colon and lung cancer.

It is also used on patients with multiple myeloma to prevent fractures and diminish the pain and lowers the calcium level.

The results of this treatment may avoid radiotherapy.

Since the beginning of the 1980's the use of bisphosphonates in treating tumor-induced hypercalcemia has had major relevance in the medical society. There are many articles available now with proven testing that biphosphonates used at the right dosage can prevent hypercalcemia, which is due to cancer in bone, which may manifest itself in the form of pathologic fractures and bone destruction. It will also help the severe pain due to the metastasis caused by the spreading of the cancer to the bone.

Osteolysis of malignant disease (metastasis) arises from increased bone resumption, usually associated with the increased osteoclast activity and deficient osteoblast response (the rebuilder of the bone), that results in a progressive loss of bone. As the problem progresses, the bones change the structure and become fragile and weak and may break easily.

Clodromax clodronate disodium is a bone resumption inhibitor that is available in:

Ampoules
Capsules
Intravenous
Oral administration

Each ampoule contains 20ml of sterile solution with 100mg per ml. of clodronate disodium. The pH of the solution of clodronate disodium is approximately 6.3. Clodromax is a member of the group of chemical compounds known as bisphosphonates. Clodronate disodium is designated chemically as "disodium dihydrogen" (1-hydroxyethytidene) bisphosphonate.

Clinical Pharmacolog

Because of decreased release of phosphate from bone and increased renal excretion as parathyroid hormone levels which are usually suppressed in hypercalcemia associated with malignancy action of Clodromax is inhibition of bone resumption, although the mechanism of antiresorptive action is not completely understood.

Several factors contribute to this action. Clodromax absorbs calcium phosphate (hydroxyapatite) crystal in bone, in vitro studies also suggest that inhibition of osterclast activity contribute to the inhibition of bone resumption in animal studies as doses recommended for the treatment of hypercalcemia.

Clodromax inhibits bone resumption apparently without inhibiting bone formation and mineralization of relevance to the treatment of hypercalcemia. Serum phosphate levels have been noted to decrease after administrating Clodromax. They return to normal within 7-10 days.

Indications and Usag

Clodromax must be used in conjunction with adequate hydration, which is indicated for treatment of moderate or severe hypercalcemia that is associated with malignancy with or without bone metastasis.

Patients who have epidermis tumors respond to this treatment, but vigorous saline hydration is an integral part of hypercalcemia therapy and must be initiated promptly to restore urine output to about 2 liters daily throughout the treatment. Overhydration, especially in those patients who have cardiac failure, must be avoided.

Contraindication

Clodromax is contraindicated in patients with clinically significant hypersensitivity to other bisphosphonates

Dosage:

The recommended dose of Clodromax is 7 mg/Kg for every 3-day period.

The dose should be diluted in 100ml of sterile solution which contains 0.45% or 0.9% of sodium chloride USP.

Side Effects:

High temperature

Redness

Swelling

Pain in the area of the application (infusion method).

Occasionally tiredness

Nausea

Epigastric pain

Lack of appetite

Alterations in taste occur relatively often, but will eventually disappear.

The oral form may, although very rare, cause a reaction in those patients who have active gastro-duodenal ulcers.

Reference Publications Available:
Double blind, placebo controlled, dose-response trial of oral Clodronate in patients with bone metastasis. Noelle Or'Rourke, Eugene McCloskey, Journal of Clinical Oncology, Vol 13, No. 4 (April 1995, pp 929-934)

Reduction in calcium excretion in women with breast cancer and bone metastasis using oral Clodronate (bisphosphonate pamidronate) D.J. Dodwell, A. Howell, Br. J Cancer 1990, Jan.: 61(1): 123-5.

Clodronate and Osteoporosis. Kanis J.A., McCloskey EV Maturitas 1996, 23 (suppl): 581-6

Pharmacology and use in the treatment of tumor-induced hypercalcemia and metastasic bone disease. Fleish H. Drugs 1991; 42:919-44

Natural history of skeletal disease in multiple myelomatosis and treatment with Clodronate. McCloskey EV, O'Rouke N.bone Miner 1992: 17 (suppl): S27

Palliation of painful bone metastasis from prostate cancer using sodium etidronate result in randomized, prospective double blind placebo controlled study. Smith, J.A.. J.Urol 1989, 141: 85-7.

Clodromax

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