Osteogenesis ImperfectaMOVE-OINCT04119388
Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
A study testing Adapted sports practices in people with Osteogenesis Imperfecta, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low bone mass. It is conceivable that children and adolescents with OI are less active than healthy peers because of frequent fractures, immobilization,functionals limitations and no adapted physicals activity(APA). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Adapted sports practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2019to 14 Oct 2022
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with osteogenesis imperfecta
- Child followed in the Reference centre for constitutional bone diseases in the Hôpital Femme Mère Enfant
- Parent (s) / legal guardian who has been informed of the study and has accepted participation in the study by signing the consent.
- Patient benefiting from a social security scheme
Who cannot join
- Medical and surgical contraindications to adapted physical activity.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant
Bron, 69500
About this study
Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low bone mass. It is conceivable that children and adolescents with OI are less active than healthy peers because of frequent fractures, immobilization,functionals limitations and no adapted physicals activity(APA). The hypothesis is that an Adapted physique activity could improve access of activity for patients with Osteogenesis Imperfecta (OI).
The aim of the study is to evaluate benefice of APA,improve aerobic capacity, cardiovascular and bone benefits, and gain of quality of life.
Children with OI between 6 and 18 years old will have a program of supervised "adapted training program" during one year. The program is adapted at each individual and without risk for the patient.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Adapted sports practices
- Keywords
- osteogenesis imperfecta, Adapted sport, Quality of life
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted sports practicesOther
Adapted sports practices for 30 minutes twice a week
| Study group | Role | What they receive |
|---|---|---|
| Adapted sports practice | Experimental | patients with osteogenesis imperfect will practice adapted sport twice a week during 12 months in order to improve their aerobic capacity, cardiovascular and bone benefits, and gain of quality of life. Receives: Other: Adapted sports practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk test
Distance traveled (in meters) in 6 minutes
Measured: Month 0
6 minutes walk test
Distance traveled (in meters) in 6 minutes
Measured: Month 6
6 minutes walk test
Distance traveled (in meters) in 6 minutes
Measured: Month 12
Secondary outcomes (51)
Weight
weight in kilograms will be measured with a scale
Measured: Month 0
Weight
weight in kilograms will be measured with a scale
Measured: Month 6
Weight
weight in kilograms will be measured with a scale
Measured: Month 12
Height
Size in meter measured with a meter
Measured: Month 0
Height
Size in meter measured with a meter
Measured: Month 6
Height
Size in meter measured with a meter
Measured: Month 12
body mass index
calculated with weight and height
Measured: Month 0
body mass index
calculated with weight and height
Measured: Month 6
body mass index
calculated with weight and height
Measured: Month 12
blood pressure
measurement of blood pressure (cm Hg)
Measured: Month 0
blood pressure
measurement of blood pressure (cm Hg)
Measured: Month 6
blood pressure
measurement of blood pressure (cm Hg)
Measured: Month 12
phosphocalcic biologic parameters
Ionosodium (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
potassium (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
calcium (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
chlore (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
bicarbonates (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
glucose (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
urea (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
creatinemia (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
phosphorus (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
proteinemia (g/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
Vitamin D (nmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
1-25 OH vitamin D (pmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
PTH (ng/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
alkaline bone phosphatases (U/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
CTX (pg/ml)crosslaps
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
osteocalcin (µg/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
ferritin (µg/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
blood count formula : leucocytes (giga/L), erythrocytes (tera/L), hemoglobin (g/L), hematocrit (%), platelets (giga/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
calciuria (mmol/L)
Measured: Month 0 and Month 12
phosphocalcic biologic parameters
Ionosodium (mmol/L) potassium (mmol/L), calcium (mmol/L), chlore (mmol/L), bicarbonates (mmol/L), glucose (mmol/L), urea (mmol/L), creatinemia (mmol/L), phosphorus (mmol/L), proteinemia (g/L), Vitamin D (nmol/L), 1-25 OH vitamin D (pmol/L), PTH (ng/L), alkaline bone phosphatases (U/L), CTX (pg/ml)crosslaps, osteocalcin (µg/L), NFS, ferritin (µg/L), blood count formula : leucocytes (giga/L), erythrocytes (tera/L), hemoglobin (g/L), hematocrit (%), platelets (giga/L), calciuria (mmol/L), urinary creatinin (mmol/L).
Measured: Month 0 and Month 12
ration lean mass / fat mass
Dual-energy X-ray absorptiometry (DXA)
Measured: Month 0
ration lean mass / fat mass
Dual-energy X-ray absorptiometry (DXA)
Measured: Month 12
Respiratory Functional Exploration
Measured: Month 0
Respiratory Functional Exploration
Measured: Month 12
Thickness intima / media
echography
Measured: Month 0
Parameters of the connected watch : number of steps
data recovery of the connected watch
Measured: Month 0 and Month 6 and Month 12
Parameters of the connected watch : distance traveled
data recovery of the connected watch
Measured: Month 0 and Month 6 and Month 12
Parameters of the connected watch : calories consumption
data recovery of the connected watch
Measured: Month 0 and Month 6 and Month 12
Ratio thickness intima / media
echography
Measured: Month 12
Bone mineral density
Dual-energy X-ray absorptiometry (DXA)
Measured: Month 0
Bone mineral density
Dual-energy X-ray absorptiometry (DXA)
Measured: Month 12
Number of new fractures
Measured: Month 1
Number of new fractures
Measured: Month 3
Number of new fractures
Measured: Month 6
Number of new fractures
Measured: Month 9
Number of new fractures
Measured: Month 12
Quality of life questionnaire : PedsQL
Measurement Model for the Pedratric Quality of Life Inventory
The 4 Multidimensional Scales and 3 Summary Scores are
Scales Physical Functioning (8 items) Emotional Functioning (5 items) Social Functioning (5 items) School Functioning (5 items)
Summary Scores Total Scale Score (23 items) Physical Health Summary Score (8 items) Psychosocial Health Summary Score (15 items)
Measured: Month 0
Quality of life questionnaire : PedsQL
Measurement Model for the Pedratric Quality of Life Inventory
The 4 Multidimensional Scales and 3 Summary Scores are
Scales Physical Functioning (8 items) Emotional Functioning (5 items) Social Functioning (5 items) School Functioning (5 items)
Summary Scores Total Scale Score (23 items) Physical Health Summary Score (8 items) Psychosocial Health Summary Score (15 items)
Measured: Month 6
Quality of life questionnaire : PedsQL
Measurement Model for the Pedratric Quality of Life Inventory
The 4 Multidimensional Scales and 3 Summary Scores are
Scales Physical Functioning (8 items) Emotional Functioning (5 items) Social Functioning (5 items) School Functioning (5 items)
Summary Scores Total Scale Score (23 items) Physical Health Summary Score (8 items) Psychosocial Health Summary Score (15 items)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start4 Nov 2019
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
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 Osteogenesis ImperfectaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119388
- Sponsor's protocol ID
- 69HCL18_0747
- Other IDs
- ID-RCB
- Acronym
- MOVE-OI
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2019
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al Arab H, Flammier S, Espitalier M, Bacchetta J, Fouillet-Desjonqueres M. Evaluation of the benefits of adapted physical activity in children and adolescents with osteogenesis imperfecta: the MOVE-OI trial. Orphanet J Rare Dis. 2025 Apr 12;20(1):175. doi: 10.1186/s13023-025-03678-4.
PubMed 40221747
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT04119388
- Acronym / sponsor ID
- MOVE-OI / 69HCL18_0747
- Conditions
- Osteogenesis Imperfecta
- Keywords
- osteogenesis imperfecta, Adapted sport, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 8 Oct 2019 (actual)
- 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.
Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low bone mass. It is conceivable that children and adolescents with OI are less active than healthy peers because of frequent fractures, immobilization,functionals limitations and no adapted physicals activity(APA). The hypothesis is that an Adapted physique activity could improve access of activity for patients with Osteogenesis Imperfecta (OI).
The aim of the study is to evaluate benefice of APA,improve aerobic capacity, cardiovascular and bone benefits, and gain of quality of life.
Children with OI between 6 and 18 years old will have a program of supervised "adapted training program" during one year. The program is adapted at each individual and without risk for the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted sports practice | Experimental | Other: Adapted sports practicespatients with osteogenesis imperfect will practice adapted sport twice a week during 12 months in order to improve their aerobic capacity, cardiovascular and bone benefits, and gain of quality of life. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child with osteogenesis imperfecta
- Child followed in the Reference centre for constitutional bone diseases in the Hôpital Femme Mère Enfant
- Parent (s) / legal guardian who has been informed of the study and has accepted participation in the study by signing the consent.
- Patient benefiting from a social security scheme
Key exclusion criteria (1 listed)
- Medical and surgical contraindications to adapted physical activity.
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 |
|---|---|---|
| Adapted sports practicesAdapted sports practices for 30 minutes twice a week | Other | Adapted sports practice |
Primary outcome
6 minutes walk test
Time frame: Month 0
Distance traveled (in meters) in 6 minutes
6 minutes walk test
Time frame: Month 6
Distance traveled (in meters) in 6 minutes
6 minutes walk test
Time frame: Month 12
Distance traveled (in meters) in 6 minutes
51 secondary outcomes
Weight
Time frame: Month 0
Weight
Time frame: Month 6
Weight
Time frame: Month 12
Height
Time frame: Month 0
Height
Time frame: Month 6
Height
Time frame: Month 12
body mass index
Time frame: Month 0
body mass index
Time frame: Month 6
body mass index
Time frame: Month 12
blood pressure
Time frame: Month 0
blood pressure
Time frame: Month 6
blood pressure
Time frame: Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
phosphocalcic biologic parameters
Time frame: Month 0 and Month 12
ration lean mass / fat mass
Time frame: Month 0
ration lean mass / fat mass
Time frame: Month 12
Respiratory Functional Exploration
Time frame: Month 0
Respiratory Functional Exploration
Time frame: Month 12
Thickness intima / media
Time frame: Month 0
Parameters of the connected watch : number of steps
Time frame: Month 0 and Month 6 and Month 12
Parameters of the connected watch : distance traveled
Time frame: Month 0 and Month 6 and Month 12
Parameters of the connected watch : calories consumption
Time frame: Month 0 and Month 6 and Month 12
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 10 Sep 2025.
- Results publication: PubMed 40221747Al Arab H, Flammier S, Espitalier M, Bacchetta J, Fouillet-Desjonqueres M. Evaluation of the benefits of adapted physical activity in children and adolescents with osteogenesis imperfecta: the MOVE-OI trial. Orphanet J Rare Dis. 2025 Apr 12;20(1):175. doi: 10.1186/s13023-025-03678-4.
- Individual participant dataSharing planned: Undecided
Related trials for Osteogenesis Imperfecta
RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Osteogenesis Imperfecta (OI)
Active, not recruitingObservational study
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
Osteogenesis Imperfecta
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Active, not recruitingPhase 3
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
Active, not recruitingPhase 2/3
Setrusumab vs Placebo for Osteogenesis Imperfecta
Osteogenesis Imperfecta
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted sports practices in people with Osteogenesis Imperfecta, run by Hospices Civils de Lyon 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 4 inclusion and 1 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 10 Sep 2025. 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?
6 minutes walk test (time frame: Month 0). The study lists 3 primary outcomes in all. 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 NCT04119388, 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 10 Sep 2025.