CLODY ® - Clodronic acid

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

THERAPEUTIC GROUP: Drugs affecting bone metabolism - Bisphosphonates

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications CLODY ® - Clodronic acid

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

Mechanism of action CLODY ® - Clodronic acid

Like other bisphosphonates, clodronic acid is also able to exercise its osteoprotective activity by modulating bone turnover.

Taken parenterally injective, usually intramuscular or intravenous, this active principle is able to concentrate mainly in the bone sites subjected to resorption, selectively inhibiting the osteoriasorbent activity of the osteoclasts, safeguarding instead the neosynthetic effect 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 post-menopausal osteoporosis, and in a reduction in blood calcium concentrations, important in the course of neoplastic hypercalcemia and primary hyperparathyroidism.

The simultaneous presence in CLODY ® of a local anesthetic such as lidocaine, allows reducing the pain symptoms associated with this pathology and the administration of the drug.

Studies carried out and clinical efficacy

1. THE CLINICAL USE OF BIPHOSPHONATES

Study demonstrating that 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

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

3. NEW THERAPEUTIC SCHEMES FOR THE CLODRONATE

The use of clodronic acid with different therapeutic patterns 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 clodronate disodium

Solution for injection for intravenous use of 300 mg clodronate disodium:

the treatment of tumor osteolysis should be supervised by a specialist doctor and preferably performed in a hospital setting.

The dosage should be defined by the physician based on the clinical characteristics of the patient.

Remember that the formulation with lidocaine is indicated exclusively for intramuscular use.

Warnings CLODY ® - Clodronic acid

The high specialty of treatment with clodronic acid would require the intervention and supervision of medical specialists both in the definition phase of the dosage and throughout the therapeutic process.

Before and during the administration of this drug it would be appropriate to verify 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 the therapy in case of significant alterations.

Contextual supplementation with Vitamin D and Calcium in patients undergoing treatment with clodronic acid and not affected by hypercalcemia, could be useful to safeguard the blood concentrations of this element and avoid the onset of pathological conditions such as tetany or paresthesia.

The increased risk of osteonecrosis of the jaw in patients on CLODY ® therapy should be seriously considered before any dental treatment.

The simultaneous 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 breast filter, thus concentrating in the plasma of the fetus and the suckling child, extends the contraindications to the use of CLODY ® even during pregnancy and lactation.

Interactions

At the moment active ingredients capable of varying the pharmacokinetic and pharmacological properties of clodronic acid are not known.

However, the possible drug interactions envisaged 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 CLODY ® administration .

However, pain and irritation could also be observed during intramuscular injection, also considering that the presence of lidocaine exposes the patient to further adverse reactions.