New class drug significantly reduces spine fracture risk in postmenopausal women with osteoporosis

June 15, 2017

The results of a study presented today at the Annual European Congress of Rheumatology (EULAR) 2017 show that in postmenopausal women with osteoporosis, 12 months of treatment with romosozumab is associated with large, rapid reductions in their risk of a vertebral fracture compared to placebo.

In those women receiving romosozumab, all clinical vertebral occurred in the first two months of treatment; overall, the risk of a vertebral fracture was more than five times greater in the group of women given placebo.

"These results support this new class of drug as a highly effective treatment for postmenopausal women who have osteoporosis with established (BMD) deficit who are at increased risk of fracture," said Professor Piet Geusens, lead author from Maastricht University, The Netherlands. "The rapid and large reduction in clinical vertebral fracture risk is an important and highly relevant clinical outcome," he added.

Romosozumab is a monoclonal antibody that binds and inhibits sclerostin (a glycoprotein produced by bone cells). This action has the dual effect of increasing bone formation and decreasing bone resorption, resulting in significant increases in BMD. Previous studies have shown that romosozumab, administered subcutaneously at monthly intervals over a period of 12 months, resulted in gains in both the trabecular and cortical compartments of the spine and hip regions.

The Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) is an international, randomised, double-blind, placebo-controlled, parallel-group trial. FRAME enrolled 7,180 postmenopausal women, 55-85 years old, with evidence of osteoporosis confirmed by abnormally low density scores in their spine, hip, and femoral neck, but no severe vertebral fracture. Patients received monthly romosozumab (n=3,589) or placebo (n=3,591) for 12 months.

Initial results from FRAME had shown romosozumab was associated with a lower risk of new vertebral fractures than placebo at 12 months. The effect of romosozumab on the risk of vertebral fracture was rapid, with only 2 additional vertebral fractures (of a total of 16 such fractures in the romosozumab group) occurring in the second 6 months of therapy.

These new data from FRAME focussed on the incidence of clinical vertebral fracture in those women in the study who developed back pain consistent with this diagnosis. Monthly study visits in FRAME enabled timely X-ray confirmation of any suspected clinical vertebral fracture.

Of those 119 women reporting back pain over 12 months, 20 were diagnosed with a new or worsening vertebral fracture. In the romosozumab group, there were 3 clinical vertebral fractures (<0.1% of patients and all in the first 2 months) identified compared to 17 (0.5%) with placebo. Clinical vertebral fracture risk was 83% lower in the romosozumab group vs. placebo at 12 months. In women with clinical vertebral fracture vs. no clinical , measurements of BMD showed more severe osteoporosis; however, other baseline characteristics were comparable among all women who reported back pain in both treatment groups.

Postmenopausal osteoporosis is considered a serious public health concern due to its high prevalence worldwide. Approximately 30% of all have osteoporosis in Europe and the US; at least 40% of these women will go on to sustain one or more fragility fractures in their lifetime.

The most common fractures associated with postmenopausal osteoporosis occur at the hip, spine and wrist. Of particular concern are vertebral (spinal) and hip fractures. Vertebral fractures can result in intense back pain and deformity.

Explore further: Romosozumab significantly increases bone mineral density and bone content compared with teriparatide

Related Stories

Romosozumab significantly increases bone mineral density and bone content compared with teriparatide

June 11, 2014
A new study presented today at the European League Against Rheumatism Annual Congress (EULAR 2014) shows that in postmenopausal women with low bone mass, romosozumab significantly increased bone mineral density and bone content ...

Abaloparatide may help prevent fractures in postmenopausal women with osteoporosis

April 3, 2016
The investigational drug abaloparatide-SC (subcutaneous) may help increase bone mineral density in postmenopausal women and reduce their risk of fracture, new industry-sponsored research suggests. The results of the subgroup ...

Investigational osteoporosis drug, abaloparatide, lowers fracture risk

March 6, 2015
Abaloparatide-SC, an injectable drug being studied for the treatment of postmenopausal osteoporosis, reduces the rate of new spinal fractures by a statistically significant 86 percent and as well as statistically significant ...

Romosozumab increases bone mineral density post-menopause

January 6, 2014
(HealthDay)—Romosozumab seems safe and effective for increasing bone mineral density in postmenopausal women with low bone mineral density, according to a study published online Jan. 1 in the New England Journal of Medicine.

Injected drug reduces risk of fracture among women with osteoporosis

August 16, 2016
Among postmenopausal women with osteoporosis at risk of fracture, daily injection of the drug abaloparatide for 18 months significantly reduced the risk of new vertebral and nonvertebral fractures compared with placebo, according ...

Osteoporosis screening and treatment fall short for women with hip fractures

February 23, 2017
It's important to identify and treat osteoporosis following hip fracture, but a large study found low rates of assessment and treatment in postmenopausal women who had suffered a hip fracture.

Recommended for you

Exploring how herpes simplex virus changes when passed between family members

October 22, 2017
A new study explores how herpes simplex virus might change when passed from one individual to another, information that may prove useful in future development of therapeutics and vaccines. This rare glimpse into a transmission ...

Pneumonia vaccine under development provides 'most comprehensive coverage' to date, alleviates antimicrobial concerns

October 20, 2017
In 2004, pneumonia killed more than 2 million children worldwide, according to the World Health Organization. By 2015, the number was less than 1 million.

Newly discovered viral marker could help predict flu severity in infected patients

October 20, 2017
Flu viruses contain defective genetic material that may activate the immune system in infected patients, and new research published in PLOS Pathogens suggests that lower levels of these molecules could increase flu severity.

H7N9 influenza is both lethal and transmissible in animal model for flu

October 19, 2017
In 2013, an influenza virus that had never before been detected began circulating among poultry in China. It caused several waves of human infection and in late 2016, the number of people to become sick from the H7N9 virus ...

Flu simulations suggest pandemics more likely in spring, early summer

October 19, 2017
New statistical simulations suggest that Northern Hemisphere flu pandemics are most likely to emerge in late spring or early summer at the tail end of the normal flu season, according to a new study published in PLOS Computational ...

New insights into herpes virus could inform vaccine development

October 18, 2017
A team of scientists has discovered new insights into the mechanisms of Epstein-Barr virus (EBV) infection, as well as two antibodies that block the virus' entry into cells. The findings, published in Proceedings of the National ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.