3 Months of Romosozumab in Postmenopausal Osteoporosis Save

A report in The Lancet Diabetes & Endocrinology suggested that 3 months of romosozumab (ROMO) followed by denosumab is as effective at increasing hip bone mineral density (BMD) as the standard 12-month course. 

 

ROMO, a sclerostin inhibitor, was FDA approved in 2019 for the treatment of osteoporosis in postmenopausal women at high risk for fracture.  The duration of RMZ use is limited to 12 monthly doses, or a total of 1 year, after which anti-resorptive agent to prevent rebound loss of bone density.  This 12 month limit, noted in the product label, is because of a decline in anabolic benefits after 12 mos and concern over potential cardiovascular risk. 

This 12-month, prospective, open-label, randomised, controlled, non-inferiority trial of 50 postmenopausal (mean age 69 yrs) women (at high risk of fracture), treated women with either 3 months of ROMO (210 mg by subcutaneous injection, monthly) followed by 9 months of denosumab (60 mg by subcutaneous injection, every 6 months) or ROMO given monthly for 12 months. The primary endpoint was the percentage change in total hip BMD. The non-inferiority threshold was set at 2%. 

 

At 12 months both groups were equally effective with a mean 12-month change in total hip BMD of 5.7% vs 6%, in the 3 month ROMO vs 12 Mos. ROMO groups respectively. Hence, the abbreviated ROMO course met the prespecified non-inferiority threshold. 

Adverse events were equal between groups.

 

As ROMO has a 12 mos. use limit and is more costly, thie abbreviated course of ROMO followed by denosumab has advantages in cost, flexibility, possibly safety and offers the possibility of future 3 month courses after the first year.