ACTIVExtend: 24 months of alendronate after 18 months of abaloparatide or placebo for postmenopausal osteoporosis
Journal of Clinical Endocrinology & Metabolism Aug 12, 2018
Bone HG, et al. - This study determined the impacts of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO) in women with postmenopausal osteoporosis. Researchers reported that 18 months of ABL followed by 24 months of ALN decreased the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and increased bone mineral density (BMD). For postmenopausal women at risk for osteoporosis-related fractures, ABL followed sequentially by ALN seems to be an effective option.
Methods
- In the present study, women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN.
- After that, researchers assessed the incidence of vertebral and nonvertebral fractures and changes in BMD during the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only.
Results
- For this investigation, 558 women from ACTIVE’s ABL group and 581 from its PBO group (92% of ABL and PBO completers) were recruited.
- It was noted that during the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture compared to 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P < 0.001).
- They found that Kaplan–Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN compared to PBO/ALN (all P < 0.05).
- Data reported that gains in BMD achieved during ACTIVE were further increased during ACTIVExtend.
- Similar adverse events were noted between groups.
- A supplemental analysis for regulatory authorities detected no hip fractures in the ABL/ALN group compared to five in the PBO/ALN group.
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