Anorexia NervosaAMOSNCT02526927
Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period.
A study testing HR-pQCT, DEXA and Blood samples in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces starvation, stop of growth and impaired mineralization of bone tissue together with an interruption of pubertal development. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- HR-pQCT, DEXA and Blood samples
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2015to 29 Nov 2017
- Phase
- Interventional
- 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 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients over 20 years old:
- Age > 20 and < 30 years old
- Patients managed for AN in the pediatric or endocrinology of the university hospital of St-Etienne
- Patients who developed AN as early as the during the first stages of puberty defined by Tanner stage 1 to 4, with a diagnosis of AN based on DSM-IV current criteria:
- Weight loss : deny of maintaining body weight over minimal normal threshold (85 % age and height matched)
- Intense fear of gaining weight or becoming obese despite weight insufficiency;
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- Impaired perception of weight or dysmorphophobia;
- Excessive role of weight or body shape in self-esteem or deny of current leanness;
- Secondary amenorrhea during 3 or more menstrual cycles in young girls or primary amenorrhea
- Duration of AN of at least 6 months
- BMI >85% of theoretical BMI (efficient renutrition)
- Patients less than 20 years old :
- Age > 10 and < 20 years old
- Patients managed for AN in the pediatric or endocrinology of the university hospital of St-Etienne
- Patients who developed AN as early as the during the first stages of puberty defined by Tanner stage 1 to 4, with a diagnosis of AN based on DSM-IV current criteria:
- Weight loss : deny of maintaining body weight over minimal normal threshold (85 % age and height matched)
- Intense fear of gaining weight or becoming obese despite weight insufficiency;
- Impaired perception of weight or dysmorphophobia;
- Excessive role of weight or body shape in self-esteem or deny of current leanness;
- Secondary amenorrhea during 3 or more menstrual cycles in young girls or primary amenorrhea
- Duration of AN of at least 6 months
Who cannot join
- Renal insufficiency
- Cushing
- Dysthyroidism
- Inflammatory disease
- Pregnancy
- Lack of consent
- Subject under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Study Evaluating Bone Microarchitecture by High Resolution Quantitative Computerized Tomography (HR-pQCT) in Young Adults and Adolescents Who Developed Anorexia Nervosa (AN) in Peri or Prepubertal Period.
The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces starvation, stop of growth and impaired mineralization of bone tissue together with an interruption of pubertal development. These consequences are initially reversible following food intake return but can lead to a more irreversible status with low height, osteoporosis and high fracture risk. The onset of the disease more and more early in life, with the first stages of puberty suggest that these consequences will be even more severe as bone resistance will be damaged by more profound effects on bone growth as well. It is therefore critical to evaluate these bone metabolism alterations in order to better manage these patients.
At every age and in every clinical circumstance either physiologic or pathologic, high resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation of bone microarchitecture that is more informative than the global quantitative assessment given by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of clinical fracture risk.
Here, we propose to measure cortical parameters, such as cortical thickness which plays a key role in bone biomechanical strength in young adults aged between 20 and 30 years-old, who had developed AN as early as the during the first stages of puberty but no longer present, compared to age-and sex-matched healthy volunteers. Other micro-architectural parameters will also be studied. In an exploratory phase, we will evaluate these bone microarchitectural parameters together with bone biological turnover markers and markers of sexual maturation in adolescents or young adults 20 years-old or less, undernourished and currently managed for AN.
- Conditions
- Anorexia Nervosa
- Being tested
- HR-pQCT, DEXA, Blood samples
- Keywords
- Anorexia Nervosa, microarchitecture, prepubertal
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCTDevice
Also called Xtrem CT scanco
The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in human
DEXADevice
The Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA device that allows short duration measurements (< 15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck
Blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients 20 - 30 years-old | Experimental | HR-pQCT and DEXA for measure bone quality and quantity Receives: Device: HR-pQCT; Device: DEXA |
| Patients 10 - 20 years-old | Experimental | Blood samples, HR-pQCT and DEXA for measure bone quality and quantity Receives: Device: HR-pQCT; Device: DEXA; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical thickness
Cortical thickness (in mm) is a composite outcome measured with HR pQCTon 3D images of distal radius and distal tibia.
Measured: Day 1
Secondary outcomes (3)
Number of patients with bone degradation
Bone degradation is a composite outcome measured by cortical and architectural parameters measured with HR pQCTon 3D images of distal radius and distal tibia. The parameters are : Total volumetric bone mineral density (mg/ccm HA), Trabecular volumetric bone mineral density (mg/ccm HA), Cortical volumetric bone mineral density (mg/ccm HA), Number of bone trabeculae (1/mm), Trabecular thickness (mm) Cortical thickness (mm), Trabecular spacing (mm), Trabecular distribution (mm)
Measured: Day 1
number of patients with osteoporosis
Osteoporosis is measured with DEXA. DEXA measure the Bone Mineral Density (g/cm2)
Measured: Day 1
Clinical and biological phenotype of AN patients 20 years-old or less
Clinical and biological phenotype of AN patients 20 years-old or less is a composite factor : Pubertal stage at disease onset, Duration of AN, Height shortening compared to optimal genetically defined height, Serum levels of FGF23, Serum levels of IGF 1, Serum levels of sexual steroids (FSH, LH, oestradiol, testosterone, SeBG, AMH, inhibin B), Serum levels of bone formation and resorption markers (cross laps, osteocalcin, total alkaline phosphatases), Serum levels of leptin, Bone mineral density measured by DXA
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start23 Nov 2015
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
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 Centre Hospitalier Universitaire de Saint EtienneThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry THOMAS, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526927
- Sponsor's protocol ID
- 1408082
- Other IDs
- 2015-A00100-49
- Acronym
- AMOS
- Status last verified
- Feb 2018
- First submitted
- 17 Aug 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Study Evaluating Bone Microarchitecture by High Resolution Quantitative Computerized Tomography (HR-pQCT) in Young Adults and Adolescents Who Developed Anorexia Nervosa (AN) in Peri or Prepubertal Period.
- ClinicalTrials.gov ID
- NCT02526927
- Acronym / sponsor ID
- AMOS / 1408082
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, microarchitecture, prepubertal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 18 Aug 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 occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces starvation, stop of growth and impaired mineralization of bone tissue together with an interruption of pubertal development. These consequences are initially reversible following food intake return but can lead to a more irreversible status with low height, osteoporosis and high fracture risk. The onset of the disease more and more early in life, with the first stages of puberty suggest that these consequences will be even more severe as bone resistance will be damaged by more profound effects on bone growth as well. It is therefore critical to evaluate these bone metabolism alterations in order to better manage these patients.
At every age and in every clinical circumstance either physiologic or pathologic, high resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation of bone microarchitecture that is more informative than the global quantitative assessment given by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of clinical fracture risk.
Here, we propose to measure cortical parameters, such as cortical thickness which plays a key role in bone biomechanical strength in young adults aged between 20 and 30 years-old, who had developed AN as early as the during the first stages of puberty but no longer present, compared to age-and sex-matched healthy volunteers. Other micro-architectural parameters will also be studied. In an exploratory phase, we will evaluate these bone microarchitectural parameters together with bone biological turnover markers and markers of sexual maturation in adolescents or young adults 20 years-old or less, undernourished and currently managed for AN.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients 20 - 30 years-old | Experimental | Device: HR-pQCT, Device: DEXAHR-pQCT and DEXA for measure bone quality and quantity |
| Patients 10 - 20 years-old | Experimental | Device: HR-pQCT, Device: DEXA, Other: Blood samplesBlood samples, HR-pQCT and DEXA for measure bone quality and quantity |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- Patients over 20 years old:
- Patients less than 20 years old :
Key exclusion criteria (7 listed)
- Renal insufficiency
- Cushing
- Dysthyroidism
- Inflammatory disease
- Pregnancy
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 |
|---|---|---|
| HR-pQCTAlso: Xtrem CT scancoThe Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in human | Device | Patients 10 - 20 years-old, Patients 20 - 30 years-old |
| DEXAThe Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA device that allows short duration measurements (< 15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck | Device | Patients 10 - 20 years-old, Patients 20 - 30 years-old |
| Blood samples | Other | Patients 10 - 20 years-old |
Primary outcome
Cortical thickness
Time frame: Day 1
Cortical thickness (in mm) is a composite outcome measured with HR pQCTon 3D images of distal radius and distal tibia.
3 secondary outcomes
Number of patients with bone degradation
Time frame: Day 1
number of patients with osteoporosis
Time frame: Day 1
Clinical and biological phenotype of AN patients 20 years-old or less
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
Thierry THOMAS, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-pQCT, DEXA and Blood samples in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne 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 21 inclusion and 7 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: finished, as of the sponsor's last update on 22 Feb 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cortical thickness (time frame: Day 1). 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 22 Feb 2018.