CLODY ® - Clodronic acid

CLODY ® is a drug based on clodronic acid sodium salt.

THERAPEUTIC GROUP: Drugs affecting bone metabolism - Bisphosphonates

Indications CLODY ® - Clodronic acid

CLODY ® in addition to being used effectively for the treatment of osteolytic lesions secondary to menopause and neoplastic pathologies, is also indicated for the treatment of bone pain.

Mechanism of action CLODY ® - Clodronic acid

Like the other bisphosphonates, clodronic acid is also capable of exercising its osteoprotective activity by modulating bone turnover.
Taken by injection parenterally, usually intramuscularly or intravenously, this active ingredient is able to concentrate mainly in the bone sites subjected to resorption, selectively inhibiting the osteo-absorbent activity of the osteoclasts, while safeguarding the neosynthesizing activity of the osteoblasts.
The aforementioned regulatory activity results in an increase in bone mineral density, useful in the prevention of pathological fractures from bone metastases or postmenopausal osteoporosis, and in a reduction in blood calcium concentrations, important in the course of neoplastic hypercalcemia and primary hyperparathyroidism.
The contextual presence in CLODY ® of a local anesthetic such as lidocaine, allows to reduce the pain symptoms associated with this pathology and the administration of the drug.

Studies carried out and clinical efficacy

1. THE CLINICAL "UTILITY" OF BIPHOSPHONATES

Drug Des Devel Ther. 2011; 5: 445-54. Epub 2011 Oct 19.

Clinical utility of clodronate in the prevention and management of osteoporosis in patients intolerant of oral bisphosphonates.

Muratore M, Quarta E, Grimaldi A, Calcagnile F, Quarta L.

Study that demonstrates how clodronate is better tolerated than other bisphosphonates, thus representing a valid therapeutic alternative to the use of oral bisphosphonates in hypersensitive patients.

2. CLODRONIC ACID: NEW THERAPEUTIC PERSPECTIVES

Mod Rheumatol. 2011 Aug 19.

Clodronate and hydroxychloroquine in erosive osteoarthritis: a 24-month open randomized pilot study.

Saviola G, Abdi-Ali L, Campostrini L, Sacco S, Baiardi P, Manfredi M, Mannoni A, Benucci M.

New therapeutic perspective for clodronic acid which has proved effective in the treatment of erosive arthrosis and also useful in the alleviation of painful symptoms.

3. NEW THERAPEUTIC SCHEMES FOR CHLODRONATE

Adv Ther. 2010 May; 27: 314-20. Epub 2010 Jun 3.

"Twice-a-month" clodronate 200 mg IM: a new dosing regimen and improved therapy adherence in the treatment of postmenopausal osteoporosis.

Bricklayer M, Quarta L, Calcagnile F, Quarta E.

The use of clodronic acid with different therapeutic schemes could be useful and effective in the treatment of bone diseases such as postmenopausal osteoporosis.

Method of use and dosage

CLODY ®
Solution for injection for intramuscular use of 33 mg of lidocaine hydrochloride and 100 mg of disodium clodronate
Solution for injection for intravenous use of 300 mg of disodium clodronate:
the treatment of tumor osteolysis should be supervised by a specialist physician and preferably carried out in a hospital setting.
Dosage should be defined by the physician based on the clinical characteristics of the patient.
Remember that the lidocaine formulation is indicated for intramuscular use only.

CLODY ® warnings - Clodronic acid

The high specialty of treatment with clodronic acid would require the intervention and supervision of medical specialists both in the dosage definition phase and throughout the therapeutic process.
Before and during the administration of this drug it would be advisable to check the correct liver and kidney function, and the blood content of calcium, magnesium and phosphate, providing for the immediate correction of the values ​​or the suspension of therapy in case of significant alterations.
Contextual supplementation with Vitamin D and Calcium in patients undergoing treatment with clodronic acid and not suffering from hypercalcemia, could be useful to safeguard the blood concentrations of this element and avoid the onset of pathological conditions such as tetany or paraesthesia.
The increased risk of osteonecrosis of the jaw in patients receiving CLODY ® should be seriously considered before any dental treatment.
The contextual presence of Lidocaine would make the intravenous administration of this drug particularly dangerous.

PREGNANCY AND BREASTFEEDING

The ability of clodronic acid to overcome the placental barrier and the mammary filter, thus concentrating in the plasma of the fetus and infant, extends the contraindications to the use of CLODY ® also to the period of pregnancy and breastfeeding.

Interactions

There are currently no known active ingredients capable of varying the pharmacokinetic and pharmacological properties of clodronic acid.
However, the possible drug interactions expected for lidocaine, and in particular those with digitalis and cimetidine, remain to be considered.

Contraindications CLODY ® - Clodronic acid

CLODY ® is contraindicated in case of renal insufficiency and hypersensitivity to the active substance or to one of its excipients.

Undesirable Effects - Side Effects

The use of clodronic acid could lead to the appearance of the same side effects described for bisphosphonate therapy.
Nausea, diarrhea and hypersensitivity skin reactions are the main adverse reactions associated with the administration of CLODY ®.
However, pain and irritation at the site of intramuscular injection could also be observed, considering also that the presence of lidocaine exposes the patient to further adverse reactions.

Note

CLODY ® can only be sold under strict medical prescription

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