In the August edition of the journal Menopause, a research paper was published that noted that a three-year study confirmed the effectiveness and safety of DUAVEE (bazedoxifene) for the treatment of osteoporosis in postmenopausal women. The seven-year study was comprised of 7,492 women who were randomly assigned to receive DUAVEE 40 mg, DUAVEE 20 mg or a placebo. The investigators found that, compared to the placebo, the 20 MG dose of DUAVEE reduced the risk of fracture by 42% and the 20 mg dose reduced the fracture risk by 37% in generally healthy postmenopausal women with osteoporosis.
At seven years, the cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4%) and bazedoxifene 20 mg (7.6%) groups than in the placebo group (9.9%); the relative risk reductions were 36.5% and 30.4%, respectively. DUAVEE had no effect on the overall incidence of nonvertebral fractures (bazedoxifene. Seven-year decreases in total hip bone mineral density were significantly smaller in the DUAVEEE groups than in the placebo group, In addition, DUAVEE was found to have a favorable safety/tolerability profile over the seven year period. Similar adverse events, serious adverse events, and study discontinuations were similar in the two DUAVEE GROUPS and the placebo group.
The authors concluded that the effectiveness and safety of bazedoxifene was sustained during the seven year study of women with osteoporosis.
Osteoporosis affects more than 10 million Americans over the age of 50, with women four times more likely to develop osteoporosis than men. Another 34 million Americans over the age of 50 have low bone mass (osteopenia) and therefore have an increased risk for osteoporosis. Estrogen deficiency is one of the main causes of bone loss in women during and after menopause. Women may lose up to 20% of their bone mass in the five to seven years following menopause.
Although the exact medical cause for osteoporosis is unknown, a number of factors contribute to osteoporosis, including the following:
- Aging: bones become less dense and weaker with age.
- Race: Caucasian and Asian women are most at risk, although all races may develop the disease.
- Body weight: obesity is associated with a higher bone mass; therefore, individualse who weigh less and have less muscle are more at risk for developing osteoporosis.
- Lifestyle factors; the following lifestyle factors may increase a person’s risk of osteoporosis:
- Physical inactivity
- Excessive alcohol use
- Dietary calcium and vitamin D deficiency
- Certain medications
- Family history of bone disease
In 2006, the North American Menopause Society (NAMS) reviewed and updated its guidelines on the diagnosis, prevention, and treatment of postmenopausal osteoporosis. Among its updated recommendations, NAMS suggests that women’s lifestyle practices should be reviewed regularly by their doctors, and that practices that help to reduce the risk for osteoporosis should be encouraged. Also, NAMS recommends that a woman’s risk for falls should be evaluated at least once a year after menopause has occurred. An additional recommendation is that a woman’s height and weight should be measured annually, and she should be assessed for kyphoses–development of a rounded humped spines–and back pain.