Abaloparatid (1) – Eladynos®

• Clinical trials
  • The study compared the efficacy and safety of abaloparatide with those of teriparatide and placebo over a period of 18 months.
  • Whilst the abaloparatide and placebo arms were blinded, teriparatide was administered to study participants in an open-label manner.

Postmenopausal women with osteoporosis and an increased risk of fracture

• For postmenopausal women with osteoporosis and an increased risk of fracture, the additional benefit of abaloparatide over the appropriate comparator therapy is not proven.
• The ACTIVE study cannot be used to establish the additional benefit of abaloparatide, as the comparison of abaloparatide with teriparatide alone does not correspond to the currently defined appropriate comparator therapy.
• For the implementation of patient-specific treatment in a direct comparative trial, it is expected that trial doctors will have a choice of several active ingredients (INNs) specified in the appropriate comparator therapy, in order to enable a patient-specific treatment decision to be made, taking into account fracture risk and prior treatment.
• There is insufficient information to determine whether, taking into account fracture risk and prior treatment, therapy with teriparatide represents the most appropriate individualised treatment for all female patients in the ACTIVE trial.
• morbidity
  • Patient-relevant endpoints were recorded in the categories of morbidity (e.g. occurrence of new vertebral fractures) and side effects.
• Overall assessment
  • For postmenopausal women with osteoporosis and an increased risk of fracture, there are therefore no suitable data available to assess the additional benefit of abaloparatide compared with the appropriate comparator therapy.
  • An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.