Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
Status:
Completed
Trial end date:
2021-07-22
Target enrollment:
Participant gender:
Summary
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to
investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators
hypothesize that 12 months of denosumab administration will result in an increase in bone
mineral density, decrease in markers of bone resorption and improvement in bone
microarchitecture in osteopenic women with anorexia nervosa compared with placebo.
An optional extension study will offer subjects 12-month administration of open-label
alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab
or placebo. We hypothesize that 12 months of denosumab 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 denosumab followed by 12 months of alendronate, we
hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.