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Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.

Saag KG, Petersen J, Brandi ML, et al. The New England journal of medicine 2017 · PMID 28892457 · doi:10.1056/nejmoa1708322

Question

In postmenopausal women at very high fracture risk, is 12 months of romosozumab followed by alendronate better than alendronate alone?

Design

International multicentre double-blind active-controlled RCT.

Patients

Postmenopausal women with osteoporosis and a prior fragility fracture (very high fracture risk).

Intervention

Romosozumab monthly for 12 months, then alendronate

Comparison

Alendronate throughout

Primary outcome

New vertebral fracture at 24 months and clinical fracture at primary analysis

Key result

Romosozumab-then-alendronate significantly reduced new vertebral, clinical and hip fractures compared with alendronate alone.

Limitations

An imbalance in serious cardiovascular events (myocardial infarction and stroke) was seen in the first year in the romosozumab arm.

Impact on practice

Supports anabolic-first treatment in very high-risk patients; NICE TA791 recommends romosozumab for severe osteoporosis after a fragility fracture, but it is contraindicated with prior MI or stroke.