Bone Loss, Age-RelatedNCT02751008
Bone Fragility Study in Pediatric Population With Risk Factors
An observational study of Bone Loss, Age-Related, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Low bone mass and osteoporosis are underdiagnosed in childhood in our environment and its prevalence is unknown. In most cases they are secondary to chronic diseases that conduct to a poor bone health condition and thereby a risk of fracture increased. Read more about this study
- Who is it for?
- Ages 2 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Age-Related
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jun 2018
- Phase
- Observational
- 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 2 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients under 21 years of age who are at risk of bone fragility (pediatric patients with primary bone diseases or potential secondary bone diseases (eg , chronic inflammatory diseases , endocrine disorders , history of cancer or pre- transplant) and whose parents / guardians have signed the informed consent
Who may be able to join
- Patients under 21 years of age who are at risk of bone fragility ( according to criteria previously set forth in the background section ) and whose parents / guardians have signed the informed consent
Who cannot join
- Subjects who refuse to participate in the study. Over 16 years old. Bone prior active treatment .
About this study
Low bone mass and osteoporosis are underdiagnosed in childhood in our environment and its prevalence is unknown. In most cases they are secondary to chronic diseases that conduct to a poor bone health condition and thereby a risk of fracture increased. The aim of this study is to identify patients with risk factors for low bone mass and determine their Bone Mineral Density (amount of bone) by performing bone densitometry and compared with healthy population of the same characteristics. Also the investigators want to evaluate bone quality by application of Trabecular Bone Score to images obtained by densitometry. As secondary objectives the investigators intend to correlate the data with with clinical variables to identify the most important in bone health clinical factors. In addition to measuring bone quality and quantity demographic and clinical process related to bone quality base and variables will be collected.
Read the detailed description
Osteoporosis (OP) in children is a rare disease whose incidence is unknown, partly due to lack of diagnosis associated with the absence of specific clinical symptoms in the early stages of the disease.
That is why the active recognition of this disease by the pediatrician and the pediatrician rheumatologist is essential to prevent future complications: fractures and comorbidity associated with them, including possible deformities and the need for surgical correction.
The diagnosis of OP in children and adolescents requires the combination of densitometric criteria (low bone mass or deficits in mineralization) and the clinical judgment of clinically significant fracture. Any of the following fractures are considered clinically significant fractures: Long bone fracture of the lower limbs, vertebral compression fracture, or two or more long bone fractures of upper extremities.
Low bone mass for age is considered when the Z-score of the measurement of bone mineral density (BMD) is less than or equal to -2, adjusted for age, sex and body mass index.
The Z-score is a value that is calculated by subtracting the average patient BMD BMD their age group and gender and this value by dividing the standard deviation of their age group and gender.
DXA (dual-energy X ray absortiometry) lumbar and whole body (excluding the head) is the method of choice for measuring bone mineral density (BMD), since it is the most accurate skeletal location and reproducible for measuring BMD.
Juvenile Idiopathic Osteoporosis is a very rare entity, with less than 200 cases described in the literature, and whose diagnosis requires the exclusion of secondary forms of osteoporosis.
Among the causes of osteoporosis (low bone mass or) secondary in child population the investigators have: kidney diseases, metabolic diseases, hematological, endocrinological, gastrointestinal and rheumatological, including chronic systemic disorders. The transplant and cancer patients have generally a multifactorial risk of osteoporosis (immobilization, medical treatment, etc.).
Also, nutritional causes are another large block of secondary forms of child and / juvenile (or low bone mass for age) osteoporosis. Typical examples of malabsorptive disease are celiac disease, cystic fibrosis and chronic inflammatory bowel disease and anorexia nervosa.
Special attention should pediatric patients treated with nonsteroidal antiinflammatory drugs, methotrexate and, of course, glucocorticoids, potent inducers and inhibitors of osteoclastogenesis osteoblastogenesis.
Other medications that affect a greater risk of developing osteoporosis are: some anticonvulsants, anticoagulants and chemotherapies.
According to the ISCD (International Society for Clinical Densitometry) should be performed by DXA bone densitometry as a measure of bone health assessment of all children with increased risk of fracture. They are therefore candidates for a bone densitometry pediatric patients with primary bone diseases or potential secondary bone diseases (eg, pre-transplant chronic inflammatory diseases, endocrine disorders, cancer or history).
While DXA is the only validated technique today for indirect measurement of fracture risk in itself is only able to analyze changes in bone mineral content, so recently they have intensified efforts to validate other techniques possible to assess not only the quantity but also the quality of the bone. Among the highlights is the TBS (Trabecular Bone Score) which is software that applied directly to the information obtained through the spinal DXA can analyze the trabecular number, thickness and connectivity, providing extra information about the strength or weakness of the vertebra. Its use is spreading in routine clinical practice in the adult population as it is safe and does not increase the time required exploration, however in the pediatric population is not included in routine practice even though its application could provide additional information to the DMO on which to base treatment decisions.
- Conditions
- Bone Loss, Age-Related
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mass
Measured: 1 day visit
Secondary outcomes (1)
Bone quality
Performing Trabecular Bone Score vapplied directly to the information obtained through the spinal DXA
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, Age-RelatedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751008
- Sponsor's protocol ID
- IIBSP-FRA-2016-11
- Status last verified
- Nov 2018
- First submitted
- 11 Apr 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Fragility Study in Pediatric Population With Risk Factors
- ClinicalTrials.gov ID
- NCT02751008
- Acronym / sponsor ID
- IIBSP-FRA-2016-11
- Conditions
- Bone Loss, Age-Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Apr 2016 (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.
Low bone mass and osteoporosis are underdiagnosed in childhood in our environment and its prevalence is unknown. In most cases they are secondary to chronic diseases that conduct to a poor bone health condition and thereby a risk of fracture increased. The aim of this study is to identify patients with risk factors for low bone mass and determine their Bone Mineral Density (amount of bone) by performing bone densitometry and compared with healthy population of the same characteristics. Also the investigators want to evaluate bone quality by application of Trabecular Bone Score to images obtained by densitometry. As secondary objectives the investigators intend to correlate the data with with clinical variables to identify the most important in bone health clinical factors. In addition to measuring bone quality and quantity demographic and clinical process related to bone quality base and variables will be collected.
Detailed description
Osteoporosis (OP) in children is a rare disease whose incidence is unknown, partly due to lack of diagnosis associated with the absence of specific clinical symptoms in the early stages of the disease.
That is why the active recognition of this disease by the pediatrician and the pediatrician rheumatologist is essential to prevent future complications: fractures and comorbidity associated with them, including possible deformities and the need for surgical correction.
The diagnosis of OP in children and adolescents requires the combination of densitometric criteria (low bone mass or deficits in mineralization) and the clinical judgment of clinically significant fracture. Any of the following fractures are considered clinically significant fractures: Long bone fracture of the lower limbs, vertebral compression fracture, or two or more long bone fractures of upper extremities.
Low bone mass for age is considered when the Z-score of the measurement of bone mineral density (BMD) is less than or equal to -2, adjusted for age, sex and body mass index.
The Z-score is a value that is calculated by subtracting the average patient BMD BMD their age group and gender and this value by dividing the standard deviation of their age group and gender.
DXA (dual-energy X ray absortiometry) lumbar and whole body (excluding the head) is the method of choice for measuring bone mineral density (BMD), since it is the most accurate skeletal location and reproducible for measuring BMD.
Juvenile Idiopathic Osteoporosis is a very rare entity, with less than 200 cases described in the literature, and whose diagnosis requires the exclusion of secondary forms of osteoporosis.
Among the causes of osteoporosis (low bone mass or) secondary in child population the investigators have: kidney diseases, metabolic diseases, hematological, endocrinological, gastrointestinal and rheumatological, including chronic systemic disorders. The transplant and cancer patients have generally a multifactorial risk of osteoporosis (immobilization, medical treatment, etc.).
Also, nutritional causes are another large block of secondary forms of child and / juvenile (or low bone mass for age) osteoporosis. Typical examples of malabsorptive disease are celiac disease, cystic fibrosis and chronic inflammatory bowel disease and anorexia nervosa.
Special attention should pediatric patients treated with nonsteroidal antiinflammatory drugs, methotrexate and, of course, glucocorticoids, potent inducers and inhibitors of osteoclastogenesis osteoblastogenesis.
Other medications that affect a greater risk of developing osteoporosis are: some anticonvulsants, anticoagulants and chemotherapies.
According to the ISCD (International Society for Clinical Densitometry) should be performed by DXA bone densitometry as a measure of bone health assessment of all children with increased risk of fracture. They are therefore candidates for a bone densitometry pediatric patients with primary bone diseases or potential secondary bone diseases (eg, pre-transplant chronic inflammatory diseases, endocrine disorders, cancer or history).
While DXA is the only validated technique today for indirect measurement of fracture risk in itself is only able to analyze changes in bone mineral content, so recently they have intensified efforts to validate other techniques possible to assess not only the quantity but also the quality of the bone. Among the highlights is the TBS (Trabecular Bone Score) which is software that applied directly to the information obtained through the spinal DXA can analyze the trabecular number, thickness and connectivity, providing extra information about the strength or weakness of the vertebra. Its use is spreading in routine clinical practice in the adult population as it is safe and does not increase the time required exploration, however in the pediatric population is not included in routine practice even though its application could provide additional information to the DMO on which to base treatment decisions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients under 21 years of age who are at risk of bone fragility (pediatric patients with primary bone diseases or potential secondary bone diseases (eg , chronic inflammatory diseases , endocrine disorders , history of cancer or pre- transplant) and whose parents / guardians have signed the informed consent
Key inclusion criteria (1 listed)
- Patients under 21 years of age who are at risk of bone fragility ( according to criteria previously set forth in the background section ) and whose parents / guardians have signed the informed consent
Key exclusion criteria (1 listed)
- Subjects who refuse to participate in the study. Over 16 years old. Bone prior active treatment .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone mass
Time frame: 1 day visit
1 secondary outcome
Bone quality
Time frame: 1 day visit
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 14 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Loss, Age-Related, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 1 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 mass (time frame: 1 day visit). 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 14 Nov 2018.