Anorexia Nervosa Clinical Trial
Official title:
Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa
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
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).
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