Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Value of bone mineral density in lumbar spine (g/cm2)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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).
Intervention: Denosumab subcutaneous injections (Drug)
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).
Intervention: Placebo subcutaneous injections (Drug)
Outcomes
Primary Outcomes
Value of bone mineral density in lumbar spine (g/cm2)
Time Frame: 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 Outcomes
- values of bone mineral density at 24 months(24 months)
- values of bone remodeling markers at 24 months(24 months)
- links between ESR1 genotype and bone minéral density at Baseline and response to Denosunab(12 months)
- value of bone mineral density in the whole body, the total proximal femur and the radius (g/cm2)(12 months)