FDA approves Boniva a monthly osteoporosis medication

Boniva will be the first monthly osteoporosis medication to help women battle the bone-weakening disease and it has been approved by the Food and Drug Administration, said Dr. Ronald Emkey of Radiant Research in Reading, Pa., which conducted trials of the drug.

Current medications are taken weekly.

Boniva, approved late Thursday, is being jointly promoted by the drug companies, GlaxoSmithKline and Roche.

The companies estimate that 44 million Americans over age 50 suffer from osteoporosis

Known as ibandronate sodium, the 150 milligram tablets are intended for both treatment and prevention of postmenopausal osteoporosis. The drug is expected to go on sale, by prescription, in April.

The companies said they were setting up a patient support program to help patients remember to take the drug every month and to stay on the medication.

In trials over three years the drug reduced the number of new vertebral fractures in women with osteoporosis and increased bone density in women who had not developed the disease. The most common side effects reported were abdominal pain, high blood pressure, upset stomach, joint pain, nausea and diarrhea.
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Boniva, known as Bonviva in Europe, is part of a popular class of drugs known as bisphosphonates that aim to treat post-menopausal women with osteoporosis.

Osteoporosis is most common in older women when levels of the female hormone estrogen drop. It occurs in about one in three elderly women and one in 12 older men.

Osteoporosis is a disease in which bones become fragile and more likely to break. If not prevented or if left untreated, osteoporosis can progress painlessly until a bone breaks. These broken bones, also known as fractures, occur typically in the hip, spine, and wrist.

Any bone can be affected, but of special concern are fractures of the hip and spine. A hip fracture almost always requires hospitalization and major surgery. It can impair a person’s ability to walk unassisted and may cause prolonged or permanent disability or even death. Spinal or vertebral fractures also have serious consequences, including loss of height, severe back pain, and deformity.

A daily version of the pill was first approved by the FDA in 2003, but the companies never launched the product as they explored a more convenient dosing for the medicine to treat brittle bones.