Major bone trial to test high dose corticosteroid steroid tablets

Nov 8 2004

Researchers in Aberdeen are about to launch a major multi-centre clinical trial to test whether a new drug could prevent bone thinning in adults taking moderate to high dose corticosteroid "steroid" tablets, such as prednisolone.

Corticosteroids are widely used to treat a number of medical disorders. At any one time around 1% of adults in the UK will be taking them orally for a range of conditions which include rheumatoid arthritis, asthma, inflammatory bowel disease and a number of skin diseases. That figure rises to 2.5% in people aged between 70 and 79.

However, it is estimated that around 350,000 people in Britain are at risk of fractures as evidence suggests that use of prolonged moderate to high doses of corticosteroid tablets could lead to the patient developing corticosteroid induced osteoporosis or thinning of the bones.

Use of prednisolone tablets in a daily dosage of 7.5mg or more are associated with an increase in fracture risk at the hip and spine because the drugs are linked with loss of bone mineral density. Daily doses of 5mg per day are also associated with the risk of vertebral or spine fractures.

Researchers at the University of Aberdeen are about to head up the UK part of a large international trial to establish whether the co-prescription of an additional medication - from a class of drugs known as bisphosphonates - prevents bone loss in people taking high dose steroid tablets.

All men and women who are on steroids in a dose of at least 7.5mg of prednisolone per day will be offered an active bisphosphonate either by injection or in tablet form to help to prevent the development of osteoporosis.

Professor David Reid, Professor of Rheumatology, and also leader of the clinical research side of the University’s internationally recognised Bone Research Group, said: This is a really exciting trial as, if successful, it will increase the available options for the prevention of the adverse effects of corticosteroids on the skeleton.

“Steroids are very valuable for improving the quality of life of so many of our patients but the prevention of the adverse effects on the bone still needs some improvement. Part of our research group under the guidance of Professor Mike Rogers is already at the international forefront of knowing how bisphosphonates work and this clinical trial will help us to continue this very intriguing work.”

As well as Aberdeen, trial involves three other centres in the UK as well as 70 other centres in North and South America, Asia, Oceania and Europe.

Patients who are either taking - or about to start - high dose steroid tablets are being asked whether they would like to take part in the randomised study which will begin shortly and last one year.