AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Medical subject headings
Osteoporosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone mass

    Measured: 1 day visit

Secondary outcomes (1)
  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.

  1. First posted26 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2018
  4. Study completionJun 2018

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in