World’s largest-ever bone biopsy study

Monday, 28 March 2011:The results of the world’s largest-ever bone biopsy study in postmenopausal women were presented on 24 March at the European Congress on Osteoporosis and Osteoarthritis (ECCEO) in Valencia, Spain.

The global study, which compared the efficacy of the osteoporosis treatment strontium ranelate with the commonly prescribed bisphosphonate, alendronate, found that strontium ranelate has significantly greater bone-forming activity than alendronate.  In fact, strontium ranelate was found to be 17 times more effective than the standard osteoporosis treatment.

The study sets a new standard in assessing the effects of different osteoporosis treatments on bone.

The results of this study are of global significance given that the disease is a major international public health problem and some osteoporosis treatments have recently come under scrutiny. “Two hundred million women worldwide are affected by the condition and 40% of females over the age of 50 will suffer at least one fracture as a result,” Dr Jean-Yves Reginster, Chairperson of the European Osteoporosis Foundation, told a press conference at ECCEO. “Also, contrary to popular impression, osteoporosis is not exclusively a female disease. As life expectancies continue to increase, male osteoporosis is becoming a growing problem.”

Several different techniques are used to assess bone structure and health, but bone biopsy is the gold standard for examining the effectiveness of osteoporosis treatments on bone.

Bone biopsies involve taking a cylindrical sample of bone from the upper part of the pelvis and are safe and well tolerated procedures.

In this international, double-blind, randomised study, 268 women aged 50 and above with diagnosed osteoporosis underwent bone biopsies prior to treatment with either strontium ranelate or alendronate, and again after 12 months. Strontium ranelate had a significantly greater effect on improving bone density compared to alendronate. The effect on bone formation was further amplified after 12 months of treatment.

“The results of the study show that strontium ranelate has a higher bone-forming activity compared to alendronate,” says study investigator Professor Roland Chapurlat from the Hôpital Edouard Herriot, Service de Rhumatologie et Pathologie Osseuse, Lyon, France.

“In a dose of 2mg/day, strontium ranelate reduced fracture at all skeletal sites, perhaps most dramatically at the hip,” adds Reginster. “It is the first treatment that has been shown to reduce hip fracture at five years – and by an impressive 43%.”

Anti-fracture efficacy sustained over 10 years

Strontium ranelate has also recently been shown to have sustained anti-fracture efficacy over 10 years, making it a first-choice treatment for postmenopausal osteoporotic women.

“The question of whether we treat beyond five years is important, as it is vital to ensure continued treatment benefit,” observes Reginster. “Strontium ranelate does not lose its efficacy and continues to reduce fracture risk, making it safe and effective for up to 10 years.”

Dr Stanley Lipschitz, a Johannesburg-based physician in private practice who specialises in geriatric medicine, says: “Essentially, these new findings confirm the results of the previous positive comparative study which showed that strontium ranelate and bisphosphonates work in completely different ways.

“Strontium ranelate actually stimulates the formation of bone, which the bisphosphonates do not. Being able to improve both the quality and the quantity of bone is a very attractive option.”

Lipschitz says he is also encouraged by safety data that is suggested from the results of this trial. “Given recent safety concerns around the long-term use of bisphosphonates, it is reassuring to know that because of its entirely different mode of action, these concerns are not applicable to strontium ranelate, which does not suppress bone remodelling (rejuvenation).”

In a separate trial currently underway, strontium ranelate was yielding positive results on the treatment of osteoarthritis.

EUROPEAN CONGRESS ON OSTEOPOROSIS AND OSTEOARTHRITIS

(23-26 March, Spain, Valencia)