NCT02567279

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Detailed description

The project propose to assess, with a double-blind multicentric randomized clinical trial, the effects of Denosumab on bone mineral density (BMD) change at lumbar spine over 12 months among patients suffering from an acute anorexia nervosa (AN). 84 patients suffering from a current anorexia nervosa with an evidence of low BMD determined by a Z-score value \< -2 DS at least one site (lumbar spine or total proximal femur) will be recruit . Eligible patients will be randomized into two groups: denosumab versus placebo. Each patient will attend a total of 8 scheduled visits, which will be completed over a period of 24 months +/- 15days from screening visit to end of study (inclusion, 10 days, and 3, 6, 12, 15, 18, \& 24 months).

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DRUG	Denosumab subcutaneous injections	Subcutaneous injection of Denosumab 60 mg, one injection at baseline and another injection at 6 months
DRUG	Placebo subcutaneous injections	Subcutaneous injection of Placebo, one injection at baseline and another injection at 6 months

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-01-03
• Completion: 2019-01-03
• First posted: 2015-10-02
• Last updated: 2019-01-07

Locations

1 site across 1 country: France