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This real practice
prospective study suggests the use of Denosumab for the osteoporotic
postmenopausal women with vertebral fractures, as they suffer from disturbed
health-related quality of life.
In recent research undertaken by the University of Campania "Luigi Vanvitelli", post-menopausal females with vertebral fractures showed significant improved HRQoL and decreased back pain-related disability with denosumab administration.
Denosumab is a type of monoclonal antibody that disrupts the osteoclast-mediated bone resorption by neutralising the receptor activator of nuclear factor kappa-Β ligand (RANKL). However, it is yet not defined whether Denosumab can overcome osteoporosis-associated disability and enhance health-related quality-of-life (HRQoL) among individuals with fragility fractures. This work evaluated the Denosumab efficacy among post-menopausal women with vertebral fractures.
A total of 140 post-menopausal osteoporosis women with age of 50 or over with at least one vertebral fracture were enrolled. Patients were administered with 60 mg Denosumab for every six months subcutaneously, and 800 IU/day Cholecalciferol and 500–1000 mg/day Calcium Carbonate for twelve months. Back pain associated disability evaluated using the Spine Pain Index (SPI) was considered as the primary endpoint. EuroQol-5D (EuroQol-Visual Analog Scale (EQ-VAS) and EuroQol-5D-3L index) and SF-12 (PCS (Physical Health Composite Score), MCS (Mental Health Composite Score)) were considered as the secondary endpoints. Both primary and secondary parameters were measured at baseline (T0), following six months (T1), and 12 months (T2) of treatment. The femoral neck (FN) BMD, Trabecular Bone Score (TBS), and lumbar spine (LS) were also assessed during T0 and T2.
A statistical
difference was seen in SF-12 PCS, EQ-5D-3L index, EQ-VAS, SPI, and SF-12 MCS
scores after the one year. FN BMD and LS BMD also showed significant
improvement. No adverse events like atypical femur fractures, new vertebral
fractures, or osteonecrosis of the jaw were seen. All these findings exhibited
the considerable impact of Denosumab among post-menopausal women with vertebral
fractures.
Current Medical Research and Opinion
Effectiveness of Denosumab on back pain-related disability and quality of life in patients with vertebral fragility fractures.
Antimo Moretti et al.
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