FOSAMAX ® - Alendronic Acid

FOSAMAX ® is a drug based on alendronic acid sodium salt

THERAPEUTIC GROUP: Drugs affecting bone metabolism - Bisphosphonates

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

Indications FOSAMAX ® - Alendronic Acid

FOSAMAX ® is successfully used in the treatment of postmenopausal osteoporosis, male osteoporosis associated with an increased risk of fractures and osteoporosis following prolonged treatment with glucocorticoids.

Mechanism of action FOSAMAX ® - Alendronic acid

FOSAMAX ® is a drug based on alendronic acid, bisphosphonate which, taken orally, is absorbed in very small quantities in the intestine and distributed mainly at the bone level.

In fact, by binding to the hydroxyapatite crystals, mainly in the sites of active bone resorption, it reduces the mobilization processes and the relative rate of replacement.

More precisely, the biological activity, still under study, seems to be carried out through the ability to bind osteoclasts, cells of the bone responsible for the deposition of matrix, and inhibit their activity through two different mechanisms responsible for inhibiting protein synthesis and energy flow.

Despite the various studies present in the literature, the action of alendronic acid is still under study, given the different potentially therapeutic roles of this active ingredient.

The proportion of the non-active drug is mostly eliminated through the urine.

Studies carried out and clinical efficacy

1. ALENDRONATO AND BONE FEMORAL FRACTURES

Latest study that demonstrates the ineffectiveness of alendronate, even when given long-term, in preventing spontaneous bone fractures of the femur.

2. ALENDRONIC ACID BY TRANSDERMIC WAY

Different research groups are working to verify the possibility of identifying alternative routes of administration to the oral one for alendronic acid. The transdermal pathway at the moment seems to provide interesting results.

3. BIPOSPHONATES AND OSTEONECROSSES OF THE MANDIBLE

Study that summarizes the role of bisphosphonates in osteonecrosis of the jaw. The increasing number of cases described since 2002 has posed a serious question regarding the dental precautions to be followed in elderly patients receiving bisphosphonate therapy, in order to reduce the incidence of this bone disease.

Method of use and dosage

FOSAMAX ®

Tablets of 10 - 70 mg of alendronic acid:

Osteoporosis treatment generally involves the intake of 10 mg daily or 70 mg once a week with a glass of water.

The intake must necessarily be carried out on an empty stomach and at least 30 minutes before taking any food or drink, given the ability of these substances to significantly reduce the bioavailability of the drug.

Furthermore, in order to avoid the appearance of possible local phlogistic reactions, the patient should take the tablet standing, after getting out of bed, avoiding lying down for 30 minutes and crushing or chewing the tablet.

A correct therapeutic approach should also include supplementation with calcium and vitamin D, in the event that the contribution of these elements is insufficient.

It should be remembered that the treatment must be supervised by a competent doctor who could also opt for a variation of the dosages.

Warnings FOSAMAX ® - Alendronic Acid

Before administering FOSAMAX ® the doctor should subject the patient to a careful medical examination useful to ascertain the absence of disorders of the upper gastrointestinal tract, previous histories of ulcers and intestinal bleeding, abdominal surgery and kidney disease.

The possible administration of alendronate in the aforementioned patients could cause a serious aggravation of the clinical picture, so it is essential for the doctor to carefully evaluate the risk / benefit ratio and subject the patient to periodic checks.

It should also be remembered that in the literature, chronic intake of bisphosphonates seems partly responsible for an increased risk of onset of osteonecrosis of the jaw.

Treatment with FOSAMAX ® should be preceded by the control of serum calcium levels in order to stabilize the blood concentration of this mineral before starting therapy.

It is shown that the use of alendronic acid is not able to prevent femoral fractures, therefore patients suffering from osteoporosis, although under FOSAMAX ® therapy, should undergo periodic checks on bone mineral density.

The doctor must also accurately inform the patient about the correct way of taking the tablet, in order to avoid even serious side effects on the digestive tract.

FOSAMAX ® contains lactose, therefore its use is not indicated in patients with lactase enzyme deficiency, galactose intolerance or glucose-galactose malabsorption syndrome.

PREGNANCY AND BREASTFEEDING

The absence of studies concerning the safety of alendronate when used in pregnancy extends the contraindications to the use of FOSAMAX ® even during pregnancy and the subsequent period of breastfeeding.

Interactions

The characteristic pharmacokinetic properties of this active ingredient impose the need to avoid the simultaneous intake of any food, drink and drug in order to avoid a significant reduction in the bioavailability of alendronic acid.

The use of antacids could reduce the absorption of the drug, just as the habitual use of non-steroidal anti-inflammatory drugs could aggravate the state of health of the gastric mucosa.

Contraindications FOSAMAX ® - Alendronic Acid

FOSAMAX ® is contraindicated in patients suffering from esophageal diseases or related diseases that can reduce the time of emptying, in patients who have difficulty maintaining their upright posture or erect bust, in case of hypocalcemia and hypersensitivity to the active ingredient or to one of the its excipients.

Undesirable effects - Side effects

The particular biological activity of alendronic acid subjects patients receiving FOSAMAX ® to an increased incidence of side effects such as: headache, cramping abdominal pain, constipation, diarrhea, esophageal ulcer, dysphagia, back sternal pain, hypersensitivity skin reactions, skeletal muscle pains.

More rarely photosensitivity reactions, lower limb edema and peptic ulcers have been observed.