Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa
Status:
Terminated
Trial end date:
2019-01-03
Target enrollment:
Participant gender:
Summary
The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal
factors that regulate the activity of bone cells. This alteration of bone remodeling is
characterized by increased bone resorption and decreased bone formation, leading to a marked
reduction of bone mineral density, osteoporosis and an increased risk of fracture.
To date, there is a paucity of studies and no consensus on the management of bone loss in
patients with AN. The few previous studies were performed with small samples and using short
follow-up periods.
Denosumab is a fully human monoclonal antibody that binds with high specificity to human
RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore
decreasing bone resorption that was found increased in patients AN.
Denosumab may transiently protect bone whilst psychonutritional management will induce a
weight restoration
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Montpellier
Collaborators:
Nantes University Hospital University Hospital, Lille University Hospital, Paris University Hospital, Rouen