Conbriza - bazedoxifene

What is Conbriza?

Conbriza is a medicine that contains the active substance bazedoxifene. The medicine is available as white, capsule-shaped tablets (20 mg).

What is Conbriza used for?

Conbriza is used for the treatment of osteoporosis (a disease that makes bones fragile) in post-menopausal women. It is indicated for women at risk of bone fractures. Conbriza has been shown to significantly reduce vertebral (spine) fractures, but not femoral (hip) fractures. The medicine can only be obtained with a prescription .

How is Conbriza used?

The recommended dose of Conbriza is one tablet once a day. The tablet can be taken at any time of the day, with or without food. Patients should also take calcium and vitamin D supplements if dietary intake is inadequate. Conbriza should be used with caution in women with severe kidney problems. The use of Conbriza in women with liver problems is not recommended.

How does Conbriza work?

Osteoporosis occurs when new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to breakage (fractures). Osteoporosis is more common in postmenopausal women when levels of the female estrogen hormone decrease: estrogen slows bone degradation and makes it less prone to fracture.

The active substance in Conbriza, bazedoxifene, is a selective estrogen receptor modulator (SERM). Bazedoxifene acts as an "agonist" of the estrogen receptor (ie a substance that stimulates the estrogen receptor) in some tissues of the body. Bazedoxifene has the same effect as estrogen on bones.

What studies have been carried out on Conbriza?

The effects of Conbriza were first tested in experimental models before being studied in humans.

Conbriza was compared with raloxifene (another medicine used to treat osteoporosis) and with a placebo (a dummy treatment) in a main study involving 7 500 women in

post-menopause affected by osteoporosis. All the women involved in the study also received calcium and vitamin D supplements. The main measure of effectiveness was the number of new vertebral fractures over three years.

Conbriza was also compared with raloxifene and a placebo in another main study involving 1, 583 postmenopausal women considered to be at risk for osteoporosis. The women were treated for two years and received calcium supplements. The main measure of effectiveness was the alteration of bone density (measurement of bone strength) in the spine following a two-year treatment.

What benefit has Conbriza shown during the studies?

In the first study, Conbriza was more effective than placebo in reducing the number of new vertebral fractures. After three years, 2% of patients treated with Conbriza (35 out of 1 724) reported new fractures compared to 4% of those treated with placebo (59 out of 1 741). A more significant difference was found in the subgroup of women at increased risk of fractures before the study. Conbriza was not effective in reducing the number of non-vertebral fractures. In the other study, Conbriza was more effective than placebo at maintaining bone density in the spine. After two years, average bone density remained almost unchanged in women taking Conbriza, but in women treated with a placebo it was reduced by more than 1%. In both main studies the effects of Conbriza were similar to those of raloxifene.

What is the risk associated with Conbriza?

The most common side effects seen with Conbriza (seen in more than 1 patient in 10)

they are hot flashes and muscle spasms. For the full list of all side effects reported with Conbriza, see the Package Leaflet. Conbriza should not be used in people who may be hypersensitive (allergic) to bazedoxifene or any other substance in the medicine. It must not be used in women who have had problems with venous thromboembolism, such as deep vein thrombosis (DVT), pulmonary embolism (blood clot in the lungs) and retinal venous thrombosis (blood clot in the back of the eye). It must not be used in women with unexplained uterine bleeding.

Conbriza can only be used in post-menopausal women, so it should not be used in women who are still able to get pregnant.

Why has Conbriza been approved?

The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Conbriza outweigh its risks in the treatment of osteoporosis in post-menopausal women with an increased risk of fractures. The Committee recommended that Conbriza be given marketing authorization.