Osseor

strontium ranelate

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Osseor?

Osseor is a medicine that contains the active substance strontium ranelate. It is available as 2-g sachets containing granules that are made up into an oral suspension.

What is Osseor used for?

Osseor is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause, to reduce the risk of broken bones in the spine and the hip.

The medicine can only be obtained with a prescription.

How is Osseor used?

Osseor is taken as one sachet once a day. The contents of the sachet are mixed into a glass of water to form a suspension and drunk just after being prepared. Osseor should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime. Osseor is intended for long-term use. Patients should receive calcium or vitamin D supplements if they are not getting enough from their diet.

How does Osseor 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. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.

The active substance in Osseor, strontium ranelate, acts on the bone structure. Once in the gut, strontium ranelate releases strontium, which is absorbed into the bone. Exactly how strontium works in osteoporosis is not fully understood, but it is known to stimulate bone formation and reduce bone breakdown.

How has Osseor been studied?

Osseor has been studied in almost 7,000 elderly women in two large studies. Nearly a quarter of the patients were over 80 years of age. The first study included 1,649 women with osteoporosis who had already had a broken bone in the spine and the second included over 5,000 women whose osteoporosis was affecting the hip region in the thighbone. In both studies, Osseor was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Osseor. In the first study, this was based on the number of patients who, over three years, developed a new break in the spine, and in the second study, it was based on the number of patients who had a new break due to osteoporosis at any site other than the spine.

What benefit has Osseor shown during the studies?

In the first study, Osseor reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Osseor developed a new break in the spine, compared with 33% of the 723 who took placebo.

Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Osseor in preventing bone breaks. However, when looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of breaks in the hip with Osseor.

When looking at results of the two studies taken together, fewer women in the Osseor group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Osseor compared with 389 out of 3,256 for placebo). This showed that the risk of broken bones is reduced.

What is the risk associated with Osseor?

The most common side effects with Osseor (seen in between 1 and 10 patients in 100) are headache, disturbances in consciousness (fainting), memory loss, nausea (feeling sick), diarrhoea, loose stools, dermatitis (inflammation of the skin), eczema (flaky skin rash), venous thromboembolism (blood clots in the veins) and increased blood creatinine kinase levels (an enzyme found in muscle). For the full list of all side effects reported with Osseor, see the Package Leaflet.

Osseor should not be used in people who may be hypersensitive (allergic) to strontium ranelate or any of the other ingredients.

Why has Osseor been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Osseor’s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral and hip fractures. The Committee recommended that Osseor be given marketing authorisation.

Other information about Osseor

The European Commission granted a marketing authorisation valid throughout the European Union for Osseor to Les Laboratories Servier on 21 September 2004. The marketing authorisation was renewed on 21 September 2009.

This EPAR was last updated on 10/10/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

18/08/2011  Osseor -EMEA/H/C/000561 -II/0028

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents