Alendronate chemical structure
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Fosamax

Alendronate (Fosamax®, Merck) is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U, under the name Fosavance). more...

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Pharmakokinetics

The systemic bioavailability after oral dosing is only 0.6 % as well in women and in men (fasting state). Intake together with meals and certain drinks (coffee, orange juice) further reduces the bioavailability. Soft tissues and bones are fastly reached by about 50%. After resorption in the bone alendronate has an estimated terminal halflife of 10 years; the remainder is excreted unchanged by the kidneys.

Pharmacology

Alendronate blocks osteoblast-mediated bone-resorption. It is chemically related to etidronate and the N-containing bisphosphonates such as pamidronate, which with it shares the same mode of action. Its inhibition of bone-resorption is dose-dependent and 100 to 1,000 times stronger than the equimolar effect of etidronate. Theoretically, alendronate may also inhibit bone-mineralization but this effect is 6,000 times weaker than the inhibition of bone-resorption. Under therapy normal bone tissue develops and alendronate is deposited in the bone-matrix in pharmacologically inactive form. For optimal action enough calcium and vitamin D are needed in the body. Hypocalcemia should therefore be corrected before starting therapy.

Uses

  • Prophylaxis and treatment of female osteoporosis
  • Treatment of male osteoporosis
  • Prevention and treatment of corticosteroid-associated osteoporosis together with supplements of calcium and vitamin D
  • Paget's disease

Contraindications and precautions

  • Acute inflammations of the gastrointestinal tract (esophagitis, gastritis, ulcerations)
  • Clinically manifest osteomalacia
  • Certain malformations and malfunctions of the esophagus (strictures, achalasia)
  • Unability to stand, walk, or sit for 30 minutes after oral administration
  • Renal impairment with a creatinine clearance below 30ml/min
  • Hypersensitivity to alendronate or another ingredient
  • Hypocalcemia
  • Pregnancy and breastfeeding
  • Patients below 18 yrs. of age, because no clinical data exists

Side-effects

  • GI tract: most prominent are harmless side effects such as mild nausea, dyspepsia, abdominal cramps, flatulence, diarrhea, or obstipation. A severe side effect is an ulceration of the esophagus caused by alendronate, which may require hospitalization and intensive treatment. Gastric and duodenal ulceration.
  • General: infrequent cases of skin rash, rarely manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis, eye problems (uveitis, scleritis) and generalized muscle, joint, and bone pain (rarely severe) have been seen. In laboratory tests decreased calcium and phosphate values may be obtained but reflect action of the drug and are harmless.
  • Osteonecrosis of the jaw, a recognised but rare side-effect of bisphosphonates

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NSAIDS and Fosamax are a bad brew - gastric ulcer risk - Brief Article
From Running & FitNews, 2/1/02

Here's another lesson for full disclosure--always tell your health care professional everything you take, whether over-the-counter, food supplement, or prescription. There are many drug interactions that can cause adverse health consequences. Sometimes one medication, supplement, or even a food like grapefruit, can increase or decrease the effectiveness of another drug's intended use (See Running & FitNews, April 1999 and March 2000). In this case, either NSAIDs or Fosamax (a drug for osteoporosis) taken alone can cause gastric ulcers, but both drugs together pack a synergistic punch. Taking the two drugs at the same time produce more than triple the risk for stomach ulcers of either drug alone.

In a study from Baylor College of Medicine, 26 healthy volunteers were randomly assigned to take Fosamax, naproxen, or both drugs together for 10 days, and then were evaluated by endoscopy for evidence of gastric ulcers. Gastric ulcers occurred in eight percent of those taking Fosamax, in 12% of those taking only naproxen, but in 38% of those taking both drugs.

Over 10 million Americans have osteoporosis and another 18 million are at risk due to low bone density Although running is protective to some extent against osteoporosis, overtraining can have the opposite effect when it is part of the Female Athlete Triad in which low estrogen levels can decrease bone density in premenopausal women. To be safe, always be sure to discuss all medications and your lifestyle with your doctor or pharmacist.

(Archives of Internal Medicine, 2000. Vol. 160, No. 5, pp. 705-708; NIH Consensus Statement 111, Osteoporosis, Prevention, Diagnosis and Therapy)

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COPYRIGHT 2003 Gale Group

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