drugset / Trial / NCT02567279

Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa

NCT02567279

RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2016-06-01
Primary completion
2019-01-03
Completion
2019-01-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Denosumab Monoclonal antibody 60 mg Subcutaneous

Indications