CONBRIZA 20 mg film-coated tablets

ATC Code
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Pfizer Ltd.

Substance Narcotic Psychotropic
Bazedoxifene No No
Pharmacological group Other sex hormones and modulators of the genital system


All to know


Pfizer Ltd.

What is it?

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

What is it used for?

Conbriza is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. It is used in women who are at risk of fracture (broken bones). Conbriza has been shown to significantly reduce fractures in the spine but not in the hip.

The medicine can only be obtained with a prescription.


How is it used?

The recommended dose of Conbriza is one tablet once a day. It can be taken at any time of day, with or without food. Patients should also receive calcium and vitamin D supplements if they do not get enough from their diet.

Conbriza should be used with caution in women with severe kidney problems. It is not recommended for use in women with liver problems.

How does it work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break (fracture). Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.

The active substance in Conbriza, bazedoxifene, is a selective oestrogen receptor modulator (SERM). Bazedoxifene acts as an ?agonist? of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body. Bazedoxifene has the same effect as oestrogen in the bone.

How has it been studied?

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

Conbriza has been compared with raloxifene (another medicine used to treat osteoporosis) and placebo (a dummy treatment) in one main study involving about 7,500 women with osteoporosis who had been through the menopause. All of the women in the study were also given calcium and vitamin D supplements. The main measure of effectiveness was the number of new spine fractures over three years.

Conbriza was also compared with raloxifene and placebo in another main study involving 1,583 postmenopausal women who were considered to be at risk of osteoporosis. The women were treated for two years and received calcium supplements. The main measure of effectiveness was the change in bone density (a measure of how strong the bones are) in the spine after two years of treatment.

What benefits has it shown during the studies?

In the first study, Conbriza was more effective than placebo at reducing the number of new spine fractures. After three years, 2% of the patients receiving Conbriza (35 out of 1,724) had new fractures compared with 4% of those receiving placebo (59 out of 1,741). The difference was more relevant in the sub-group of women at higher risk of fractures before the study. Conbriza was not shown to be effective at reducing the number of fractures outside the spine.

In the other study, Conbriza was also more effective than placebo at maintaining the bone density of the spine. After two years, the average bone density remained almost unchanged in women who received Conbriza, but in women who received placebo it was reduced by over 1%.

In both main studies the effects of Conbriza were similar to the effects of raloxifene.

What is the risk associated?

The most common side effects with Conbriza (seen in more than 1 patient in 10) are hot flushes 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 of the other ingredients. It must not be used in women who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye). It must not be used in women with unexplained bleeding from the womb. Conbriza is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Conbriza?s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. The Committee recommended that Conbriza be given marketing authorisation.

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