Anorexia NervosaPhase 3DIBLANNCT02567279
Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa
A Phase 3 study testing Denosumab subcutaneous injections in people with Anorexia Nervosa, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Denosumab subcutaneous injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 3 Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a current AN defined by DSM-V criteria
- Being female
- Age over or equal to 18 years and less or equal to 40 years
- . For patients under 20 years of age, effective bone maturation (attested by a radiography of the hip)
- Agree to take contraception up to five months after the last injection of denosumab .
- Absence of pregnancy evidenced by an interview and a negative assay of human chorionic gonadotropin (ßhCG).
- Evidence of low BMD determined by Z-score value < -2 DS (at least one site (lumbar spine or total proximal femur)
- Signing an informed consent.
Who cannot join
- Not affiliated to a social security scheme or not being the beneficiary of such a scheme.
- Severe hepatic cytolysis with transaminase up to 5 times normal.
- Severe dental problems: in case of doubt an assessment by a dentist will be required before inclusion.
- Desire of pregnancy during the two years of follow-up study.
- Disease or treatment potentially responsible for secondary osteoporosis.
- Participant already treated with a molecule known to have an effect on bone
Show all 18Show fewer
- Diabetes.
- Current hypocalcemia.
- Immunodeficiency.
- Cancer with bone lesions
- Patient on protectice measures (guardianship or trusteeship)
- Hypersensitivity to the active substance or to any of the excipients of Prolia®
- Unable to read and / or write and understand the methodology of the study
- Reporting relationship to the investigator
- Anticipate a long stay outside the region that would prevent compliance with the schedule of visits
- Participation to other biomedical research on health products
- Deprived of liberty
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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
- Being tested
- Denosumab subcutaneous injections, Placebo subcutaneous injections
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab subcutaneous injectionsDrug
Also called Treated group
Subcutaneous injection of Denosumab 60 mg, one injection at baseline and another injection at 6 months
Placebo subcutaneous injectionsDrug
Also called Control group
Subcutaneous injection of Placebo, one injection at baseline and another injection at 6 months
| Study group | Role | What they receive |
|---|---|---|
| Denosumab subcutaneous injections | Active comparator | 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). Receives: Drug: Denosumab subcutaneous injections |
| Placebo subcutaneous injections | Placebo comparator | 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). Receives: Drug: Placebo subcutaneous injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of bone mineral density in lumbar spine (g/cm2)
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.
Measured: 12 months
Secondary outcomes (4)
value of bone mineral density in the whole body, the total proximal femur and the radius (g/cm2)
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.
Measured: 12 months
values of bone mineral density at 24 months
Comparison of the levels of bone mineral density at 24 months
Measured: 24 months
values of bone remodeling markers at 24 months
Comparison of the values of bone remodeling markers at 24 months
Measured: 24 months
links between ESR1 genotype and bone minéral density at Baseline and response to Denosunab
Assess the links between ESR1 genotype and BMD at baseline and response to Denosunab (variation of BMD between baseline and 12 months).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start1 Jun 2016
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Why it stopped: Great difficulties were encountered during recruitment, for fear Denozumab. Only 2 patients have been included since the study start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Nantes University Hospital, University Hospital, Paris, University Hospital, Rouen
- Responsible party
- Sponsor
- Investigators
- Sébastien Guillaume, MD PhD, Principal investigator, Hôpital Lapeyronie - CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567279
- Sponsor's protocol ID
- 9531
- Acronym
- DIBLAN
- Status last verified
- Jan 2019
- First submitted
- 1 Oct 2015
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02567279
- Acronym / sponsor ID
- DIBLAN / 9531
- Conditions
- Anorexia Nervosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Great difficulties were encountered during recruitment, for fear Denozumab. Only 2 patients have been included since the study start.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Nantes University Hospital, University Hospital, Paris, University Hospital, Rouen
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab subcutaneous injections | Active comparator | Drug: Denosumab subcutaneous injectionsThe 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 comparator | Drug: Placebo subcutaneous injectionsThe 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with a current AN defined by DSM-V criteria
- Being female
- Age over or equal to 18 years and less or equal to 40 years
- . For patients under 20 years of age, effective bone maturation (attested by a radiography of the hip)
- Agree to take contraception up to five months after the last injection of denosumab .
Key exclusion criteria (18 listed)
- Not affiliated to a social security scheme or not being the beneficiary of such a scheme.
- Severe hepatic cytolysis with transaminase up to 5 times normal.
- Severe dental problems: in case of doubt an assessment by a dentist will be required before inclusion.
- Desire of pregnancy during the two years of follow-up study.
- Disease or treatment potentially responsible for secondary osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denosumab subcutaneous injectionsAlso: Treated groupSubcutaneous injection of Denosumab 60 mg, one injection at baseline and another injection at 6 months | Drug | Denosumab subcutaneous injections |
| Placebo subcutaneous injectionsAlso: Control groupSubcutaneous injection of Placebo, one injection at baseline and another injection at 6 months | Drug | Placebo subcutaneous injections |
Primary outcome
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.
4 secondary outcomes
value of bone mineral density in the whole body, the total proximal femur and the radius (g/cm2)
Time frame: 12 months
values of bone mineral density at 24 months
Time frame: 24 months
values of bone remodeling markers at 24 months
Time frame: 24 months
links between ESR1 genotype and bone minéral density at Baseline and response to Denosunab
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Great difficulties were encountered during recruitment, for fear Denozumab. Only 2 patients have been included since the study start.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Guillaume, MD PhD principal investigator
Hôpital Lapeyronie - CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab subcutaneous injections in people with Anorexia Nervosa, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Great difficulties were encountered during recruitment, for fear Denozumab. Only 2 patients have been included since the study start.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of bone mineral density in lumbar spine (g/cm2) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.