Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa
- Conditions
- Anorexia Nervosa
- Interventions
- Drug: Placebo subcutaneous injections
- Registration Number
- NCT02567279
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Denosumab subcutaneous injections Denosumab subcutaneous injections The treated group (n = 42) will receive Denosumab (60 mg, two subcutaneous injections at M0 and M6) associated with a daily treatment of vitamin D (800 IU) + calcium (1000 mg). Placebo subcutaneous injections Placebo subcutaneous injections The control group (n = 42) will received a placebo injection (two subcutaneous injections at M0 and M6) with daily treatment of vitamin D (800 IU) +calcium (1000 mg).
- Primary Outcome Measures
Name Time Method Value of bone mineral density in lumbar spine (g/cm2) 12 months Comparison of bone mineral density changes in the lumbar spine at M12 between groups with Denosumab and placebo after two injections either of Denosumab or placebo. Bone mineral density is objectified by the Z-score obtained by bone mineral density.
- Secondary Outcome Measures
Name Time Method values of bone mineral density at 24 months 24 months Comparison of the levels of bone mineral density at 24 months
values of bone remodeling markers at 24 months 24 months Comparison of the values of bone remodeling markers at 24 months
links between ESR1 genotype and bone minéral density at Baseline and response to Denosunab 12 months Assess the links between ESR1 genotype and BMD at baseline and response to Denosunab (variation of BMD between baseline and 12 months).
value of bone mineral density in the whole body, the total proximal femur and the radius (g/cm2) 12 months Comparison of bone mineral density changes in the whole body, the total proximal femur and the radius between groups at M12 after two injections of Denosumab.
Trial Locations
- Locations (1)
CHU Montpellier
🇫🇷Montpellier, France