Bone Loss, Age-Related Clinical Trial
Official title:
Bone Fragility Study in Pediatric Population With Risk Factors
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.
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.
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