Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to
investigate the effect of romosozumab on BMD in women with anorexia nervosa. The
investigators will also investigate the safety of romosozumab in women with anorexia nervosa.
The investigators hypothesize that 12 months of romosozumab administration will result in an
increase in bone mineral density, increase in markers of bone formation and decrease in
markers of bone resorption, and improvement in bone microarchitecture in osteopenic women
with anorexia nervosa compared with placebo.
The extension study will offer subjects 12-month administration of open-label alendronate (an
oral bisphosphonate) 70 mg once weekly after the initial 12 month administration of
romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed
by 12 months of open-label alendronate will result in a greater increase in BMD compared to
12 months of placebo followed by 12 months of open-label alendronate. Within the group of
women who receive sequential therapy with 12 months of romosozumab followed by 12 months of
alendronate, the investigators hypothesize that BMD will be maintained between 12 and 24
months while on alendronate.