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
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
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
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
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.
Diet and exercise are also important. Getting enough vitamins and minerals
-- including calcium and vitamin D -- are essential for bone health.
Weight-bearing exercise -- such as lifting weights, walking, running, or
dancing -- also builds bone strength.
Though osteoporosis is usually seen in older adults, bones take a lifetime
of care. Making bones as strong as possible when you're young gives you more
protection against osteoporosis later in life.