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Subcutaneous administration of romosozumab over a period of 12
months significantly reduced clinical vertebral fracture risk in postmenopausal
women with osteoporosis.
Postmenopausal osteoporosis is one of the common, widespread diseases throughout the world. In entire Europe and the US, about 30% postmenopausal females known to suffer from osteoporosis and 40% of these females are at the risk of getting one or more fractures in their lifespan. The fractures of the wrist, hip or spine and become the reason for intense pain & deformity are common ones.
One of the study (FRAME) published in the Annual European Congress of
Rheumatology (EULAR) 2017 press conference revealed that postmenopausal women
with the osteoporosis, got more relieved from the problem of vertebral
fractures than placebo when treated with romosozumab for 12 months. This great
reduction in risk of vertebral fracture is a significant clinical outcome.
Romosozumab is an
anti-sclerostin monoclonal antibody which reflects a binary effect among
patients. This drug helps to enhance bone formation and reduce resorption of
bones. These whole actions result to boost patients BMD up to a significant
level. Some previous studies also reported subcutaneous administration of
romosozumab process known to show improvements in cortical and trabecular
regions of the hip and spine.
The FRAME (Fracture Study in Postmenopausal Women with Osteoporosis) was an international, double-blind, randomised, placebo-controlled, parallel-group trial which involved about 7,180 female participants. The age of the participants was between 55 to 58 years old. These all women were with low bone density scores of femoral neck, spine and hip. However, no serious vertebral fracture was noticed among these women. These participants were categorized into two groups. About 3,589 women received romosozumab treatment and remaining 3,591 received placebo for 12 months.
The initial results at 12 months shown that romosozumab treatment lowered the
risk of new vertebral fractures than placebo. Further, second 6 months of the
therapy, the outcomes of this treatment were fast and with only 2 added
vertebral fractures. These new data were concentrated on those women's clinical
vertebral fractures who suffered from back pain with this diagnosis. The
scientists ensured patients monthly visit as this enabled timely X-ray
confirmation of any suspected clinical vertebral fracture.
The further results showed
that 119 women over 12 months known to suffer from back pain and diagnosed with
a new vertebral fracture. Only 3 clinical vertebral fractures were seen among
romosozumab group which is very lesser than placebo (17 fractures). Also, the
risk of fractures in romosozumab group after 12month treatment reduced up to
83% than placebo. Moreover, the BMD assessment showed more severe osteoporosis
in females with clinical vertebral fracture than no clinical vertebral
fracture. Although, all other baseline aspects were comparable among both group
women who suffered from back pain. This overall evaluation showed romosozumab
is significantly effective in postmenopausal osteoporosis management.
European League Against Rheumatism
New class drug significantly reduces spine fracture risk in postmenopausal women with osteoporosis
Professor Piet Geusens
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