denosumab (Prolia)

Advice

Following a full submission:

denosumab 60mg solution for injection in a pre-filled syringe (Prolia) is accepted for restricted use in NHSScotland. Indication under review: treatment of osteoporosis in postmenopausal women at increased risk of fractures.  Denosumab significantly reduces the risk of vertebral, non vertebral and hip fractures.

SMC restriction: use only in patients with a bone mineral density (BMD) T-score < -2.5 and ≥ -4.0 for whom oral bisphosphonates are unsuitable due to contraindication, intolerance or inability to comply with the special administration instructions.

Treatment with denosumab for three years significantly reduced the incidence of new vertebral, non-vertebral and hip fractures compared with placebo in postmenopausal women at increased risk of fractures.