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Committee for Medicinal Products for
Human Use (CHMP) favors the use of Abaloparatide in reducing the risk of fractures in
postmenopausal women at increased risk of fracture by FRAX probability.
Eighteen months of Abaloparatide notably decrease the risk for vertebral, nonvertebral, major osteoporotic, and clinical fractures, in postmenopausal women mentioned in a study issued in 'Archives of Osteoporosis'.
Abaloparatide is a novel anabolic agent used for the treatment of postmenopausal osteoporosis. The ACTIVE Study demonstrated the efficacy of abaloparatide in reducing the risk of vertebral and non-vertebral fractures as compared to placebo. The present post hoc analysis was carried out to determine the efficacy of abaloparatide in women at an increased fracture risk, based on the risk thresholds issued by Committee for Medicinal Products for Human Use (CHMP) for inclusion in clinical trials.
This post hoc analysis included women with a baseline 10-year risk of major osteoporotic fracture ≥ 10% or hip fracture ≥ 5% who were assessed using the FRAX tool (including femoral neck bone mineral density). The proportion of women with one or more events of new morphometric vertebral fractures was also evaluated. The event rates for major osteoporotic, clinical, non-vertebral and vertebral fractures was estimated using Kaplan-Meier analysis.
Abaloparatide significantly reduced
incident vertebral fractures than placebo (relative risk reduction = 91%; 0.5%
versus 5.6%) after 18 months of treatment. There were fewer major osteoporotic,
nonvertebral and clinical fractures concerned with the abaloparatide treatment
as compared to placebo (1.3% versus 6.0%, 2.7% versus 5.8%; and 3.5% versus
8.2%). Abaloparatide depicted significantly greater effect on major
osteoporotic fractures (78% reduction) than with teriparatide (23% reduction).
Archieves of Osteoporosis
Effect of abaloparatide on vertebral, nonvertebral, major osteoporotic, and clinical fractures in a subset of postmenopausal women at increased risk of fracture by FRAX probability
McCloskey EV et al.
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