Long-term Parenteral Nutrition (2 Years) in Children and AdultsAPOSTROPHENCT02368496
APOSTrophe Study (Parenteral Nutrition and Bone Trophicity) Impact of a Long-term Parenteral Nutrition on Bone Metabolism Measured by High Resolution Peripheral Quantitative Computer Tomography (HR-pQCT) in Children and Young Adults
A study testing HR-pQCT in people with Long-term Parenteral Nutrition (2 Years) in Children and Adults, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Recent progress in parenteral nutrition has contributed to improve vital prognosis and to reduce morbidity in patients with severe intestinal failure. Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for those patients. Read more about this study
- Who is it for?
- Ages 9 to 30 years
- Conditions the study is for
- Long-term Parenteral Nutrition (2 Years) in Children and Adults
- What is being tested?
- HR-pQCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2014to Jul 2016
- 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 9 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient who's receiving a long-term parenteral nutrition (over 2 years)
- Patient between 9 and 30 years of age (children big enough to stay immobile for 3 min during the measurement)
- Affiliation to the Social Security System
- Informed consent form signed by parents and assent given by the patient
Who cannot join
- Patient presenting a bone disease which is not directly related to the parenteral nutrition.
- Long-term corticotherapy ( over 6 months of therapy)
- Inability to keep the leg or the arm immobile for 3 min
- Patient not affiliated to a Social Security System
- Patient participating to another interventional study
- Pregnant patient or patient who desires pregnancy
- All situation that the physician estimated that is not compatible with the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, 69004
About this study
Official title: Parenteral Nutrition and Bone Trophicity
Recent progress in parenteral nutrition has contributed to improve vital prognosis and to reduce morbidity in patients with severe intestinal failure.
Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for those patients. However, long-term parenteral nutrition can result in complications especially in bone, such as osteopenia or osteomalacia, then increasing the risk of fractures. Children are especially at risk because of bone growth and peak mineralization acquisition during puberty.
Read more
Moreover, frequency and risk factors of those complications are not well documented for children.
Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone mineralization measurement. In pediatrics, this technique has some limits such as the underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD in tall children, and the inability to distinguish cortical from trabecular bone or to evaluate the bone microarchitecture.
HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA. However this technique has never been validated in patients with long-term parenteral nutrition.
During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in addition to the routine medical tests.
- Being tested
- HR-pQCT
- Keywords
- Long-term parenteral nutrition, HR-pQCT, DXA, Bone trophicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCTDevice
| Study group | Role | What they receive |
|---|---|---|
| Children and young adults on long-term parenteral nutrition | Experimental | long-term parenteral nutrition : 2 years Receives: Device: HR-pQCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density (BMD) and Bone mineral contain (BMC) height z-score at baseline
BMD and BMC z scores (after correction for the height) will be measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) and compared to those measured in a control group (healthy subjects matched on age and sex). The same measurements will be also compared with those obtained by Dual-energy X Ray (DXA) but in this case each subject will be considered as his own control.
Measured: J0 (baseline)
Secondary outcomes (2)
Trabecular and cortical BMD z score
Trabecular and cortical BMD (height) z score measured by HR-pQCT for patients under parenteral nutrition at baseline will be compared to those of the control group
Measured: J0 (baseline)
BMD and BMC height z score after 1 year of parenteral nutrition (PN)
BMD and BMC (height) z score measured by HR-pQCT and DXA after one year of PN will be compared, for each subject, to the measurements recorded at baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long-term Parenteral Nutrition (2 Years) in Children and AdultsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel Peretti, Dr, Principal investigator, Hospices Civils de Lyon - Hôpital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368496
- Sponsor's protocol ID
- 2013.825
- Other IDs
- 2013-A01245-40
- Acronym
- APOSTROPHE
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2014
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Louazon T, Poinsot P, Restier L, Belmalih A, Loras-Duclaux I, Marotte S, Heissat S, Barnoud D, Chambrier C, Confavreux CB, Lachaux A, Bacchetta J, Peretti N. A prospective case-control pilot study to evaluate bone microarchitecture in children and teenagers on long-term parenteral nutrition using HR-pQCT. Sci Rep. 2021 Apr 28;11(1):9151. doi: 10.1038/s41598-021-88366-6.
PubMed 33911128
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Nutrition and Bone Trophicity
- ClinicalTrials.gov ID
- NCT02368496
- Acronym / sponsor ID
- APOSTROPHE / 2013.825
- Keywords
- Long-term parenteral nutrition, HR-pQCT, DXA, Bone trophicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Feb 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.
Recent progress in parenteral nutrition has contributed to improve vital prognosis and to reduce morbidity in patients with severe intestinal failure.
Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for those patients. However, long-term parenteral nutrition can result in complications especially in bone, such as osteopenia or osteomalacia, then increasing the risk of fractures. Children are especially at risk because of bone growth and peak mineralization acquisition during puberty.
Moreover, frequency and risk factors of those complications are not well documented for children.
Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone mineralization measurement. In pediatrics, this technique has some limits such as the underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD in tall children, and the inability to distinguish cortical from trabecular bone or to evaluate the bone microarchitecture.
HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA. However this technique has never been validated in patients with long-term parenteral nutrition.
During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in addition to the routine medical tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and young adults on long-term parenteral nutrition | Experimental | Device: HR-pQCTlong-term parenteral nutrition : 2 years |
Who may qualify
- Ages
- 9 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient who's receiving a long-term parenteral nutrition (over 2 years)
- Patient between 9 and 30 years of age (children big enough to stay immobile for 3 min during the measurement)
- Affiliation to the Social Security System
- Informed consent form signed by parents and assent given by the patient
Key exclusion criteria (7 listed)
- Patient presenting a bone disease which is not directly related to the parenteral nutrition.
- Long-term corticotherapy ( over 6 months of therapy)
- Inability to keep the leg or the arm immobile for 3 min
- Patient not affiliated to a Social Security System
- Patient participating to another interventional study
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-pQCT | Device | Children and young adults on long-term parenteral nutrition |
Primary outcome
Bone mineral density (BMD) and Bone mineral contain (BMC) height z-score at baseline
Time frame: J0 (baseline)
BMD and BMC z scores (after correction for the height) will be measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) and compared to those measured in a control group (healthy subjects matched on age and sex). The same measurements will be also compared with those obtained by Dual-energy X Ray (DXA) but in this case each subject will be considered as his own control.
2 secondary outcomes
Trabecular and cortical BMD z score
Time frame: J0 (baseline)
BMD and BMC height z score after 1 year of parenteral nutrition (PN)
Time frame: 1 year
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 11 Aug 2025.
- Results publication: PubMed 33911128Louazon T, Poinsot P, Restier L, Belmalih A, Loras-Duclaux I, Marotte S, Heissat S, Barnoud D, Chambrier C, Confavreux CB, Lachaux A, Bacchetta J, Peretti N. A prospective case-control pilot study to evaluate bone microarchitecture in children and teenagers on long-term parenteral nutrition using HR-pQCT. Sci Rep. 2021 Apr 28;11(1):9151. doi: 10.1038/s41598-021-88366-6.
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.
Noel Peretti, Dr principal investigator
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-pQCT in people with Long-term Parenteral Nutrition (2 Years) in Children and Adults, run by Hospices Civils de Lyon at 2 sites 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 4 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Bone mineral density (BMD) and Bone mineral contain (BMC) height z-score at baseline (time frame: J0 (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368496, which also lists 1 linked publication.
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 11 Aug 2025.