FDA OKs First IV Osteoporosis Drug
Intravenous Boniva Is Now an Alternative to Pill Form
Jan. 13, 2006 -- The FDA has approved the first intravenous drug to treat osteoporosis in postmenopausal women.
The drug is a new form of Boniva, an osteoporosis medicine that is already approved in pill form. Boniva pills are available to take on a daily schedule or monthly.
Intravenous Boniva is an alternative for women who have trouble swallowing pills or sitting upright for 30-60 minutes after taking the pills, a requirement for patients taking osteoporosis drugs like Boniva. Sitting upright helps prevent damage to the esophagus.
Intravenous Boniva is given directly through a vein every three months and must be given by a doctor or other health care provider. The procedure takes about 15-30 seconds, states a news release from Roche and GlaxoSmithKline, drug companies that co-promote Boniva.
Women taking Boniva must also take supplemental calcium and vitamin D to help their bones. Boniva is not recommended for women with severe kidney problems.
The FDA approved intravenous Boniva based on a study of more than 1,300 postmenopausal women with osteoporosis, according to Roche and GlaxoSmithKline. The drug companies' news release describes the study.
Participants were all postmenopausal women. They either got intravenous Boniva or took a Boniva pill once daily.
Bone density improved in both groups. The bigger gains occurred in the intravenous group.
Overall safety and tolerability were similar for both forms of Boniva. The most common adverse events were joint pain, back pain, flu, abdominal pain, and inflammation of the nose and throat.
Fixing Weakened Bones
In osteoporosis, the bones are weaker and less dense than normal, making fractures more likely.
Osteoporosis becomes more common with age. It's mostly seen in women older than 50, petite women, women with a family history of osteoporosis, smokers, and white or Asian women. However, men can also develop osteoporosis.
Boniva belongs to a family of drugs called biphosphonates, which also include Actonel and Fosamax. Biphosphonates have been shown to slow bone loss, increase bone density, and reduce the risk of bone fractures, including in the spine.
There are other types of osteoporosis drugs. Fortical and Miacalcin are made from a hormone called calcitonin and delivered by nasal spray. Forteo is a man-made hormone treatment given by injection under the skin. Evista is an estrogen-like drug. Postmenopausal hormone replacement therapy has also been used to treat osteoporosis.