Osteoporosis

Two recent reports have linked the osteoporosis drug alendronate (Fosamax) with rare but serious side effects. In a letter to the New England Journal of Medicine published Jan. 1, a Food and Drug Administration official reported that since Fosamax was first marketed in 1995, 23 cases of esophageal cancer in patients taking the drug -- including eight deaths -- have been reported to the agency. And a USC study published in the January issue of the Journal of the American Dental Assn.

The family of bone-strengthening drugs called bisphosphonates -- best known by the brand names Fosamax, Actonel and Boniva -- pose a small risk of causing esophageal cancer, a Food and Drug Administration official reported Thursday in a letter to the New England Journal of Medicine. Diane K. Wysowski of the drug risk assessment division said the FDA has received 23 reports of the cancer developing in patients taking Fosamax, manufactured by Merck & Co. Eight of the patients died.

Amgen Inc. said it has filed for U.S. approval of denosumab for the treatment of osteoporosis in post-menopausal women and for bone loss in breast and prostate cancer patients undergoing hormone reduction therapy.

Just A few years back, it was heresy to suggest that, when it comes to protecting bones, early treatment may not be the answer. Part of the rite of passage through menopause a decade ago became bone-density screening. Around age 50, many women would position their skeletons under the X-ray eye of new machines that could calibrate the alarming rate at which their bones were being eaten away.

Drugs to treat osteoporosis are not without possible side effects, most notably a widely publicized condition in which jawbone tissue dies. Pun absolutely intended, Dr. Thomas B. Dodson explains, " 'Bisphosphonate-related osteonecrosis of the jaw' is a mouthful." His expertise is another mouthful -- oral and maxillofacial surgery at Massachusetts General Hospital. He's an expert on . . . let's just call it BRONJ. The problem has been linked to drugs called bisphosphonates, ranked 10th in U.S.

Biotechnology company Amgen Inc. released widely anticipated data Tuesday showing its osteoporosis drug candidate denosumab dramatically cut the risk of spinal and hip fractures in postmenopausal women, compared with a placebo. Several analysts said the data supported denosumab's position as a likely market blockbuster with annual sales of more than $1 billion, something Amgen sorely needs to offset declining sales of anemia drug Aranesp, which has been plagued with safety issues.

Amgen Inc. said its experimental osteoporosis drug denosumab reduced fractures in women with the bone-thinning disease in a study. The trial of 7,800 women with osteoporosis found that denosumab strengthened bones and reduced spinal and hip fractures, the Thousand Oaks-based company said.

Amgen Inc. said its experimental drug for osteoporosis boosted bone density among postmenopausal women in a clinical trial. The treatment, denosumab, was more effective than a placebo at increasing bone density in a study of 332 women, the Thousand Oaks-based company said.

At least three generic versions of the popular osteoporosis treatment Fosamax are headed for pharmacy shelves with the expiration of the drug's main patent Wednesday, bringing patients hefty savings. Two of the biggest makers of generic drugs, Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals Inc., said Wednesday they would immediately begin selling generic Fosamax, which is made by Merck & Co.