About this trial
Osteoporosis, a silent and multifactorial systemic skeletal disorder, severely compromises bone strength and significantly increases the risk of fragility fractures. Despite its high prevalence (affecting \~10% of Portuguese over 50), it remains critically underdiagnosed and undertreated, with over 80% of fragility fractures occurring in untreated individuals.
Chronic Kidney Disease (CKD) profoundly exacerbates bone fragility, giving rise to CKD-associated osteoporosis, a complex skeletal disorder often integrated within CKD-Mineral and Bone Disorder. This systemic dysregulation of mineral metabolism not only impairs bone quality but also actively promotes vascular calcification and significantly elevates cardiovascular disease risk, underscoring a critical kidney-bone-vascular nexus. Despite these well-established links, CKD-associated osteoporosis is similarly underdiagnosed and undertreated, partly due to diagnostic challenges related to Bone Mineral Density interpretation and therapeutic hesitancy in this complex patient population.
This multi-phase observational study is designed to address the significant public health challenges posed by osteoporosis and by osteoporosis associated with CKD in Portugal, particularly among individuals aged 40 years to 90 years. The study aims to enhance understanding of disease prevalence, identify diagnostic and treatment gaps, and evaluate management trajectories, while emphasizing the intricate interrelationships among bone health, renal function, and cardiovascular risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 40 years and 90 years;
Registered at participating Primary Healthcare Unit;
Capable of providing informed consent.
Disqualifiers
Life expectancy <12 months;
Severe cognitive/physical impairment;
Inability to undergo DXA.
Trial population
The study population comprises adults aged 40 to 90 years registered at the Primary Healthcare Units of the ULS de Barcelos/Esposende
Trial design
Cohort
Prospective
Treatments tested in this trial
Fracture risk assessment tool (FRAX)
Diagnostic testA random sample stratified by age and gender distribution from the pre-screening USF list will undergo osteoporotic fracture risk assessment via a validated, Portugal-adapted FRAX® algorithm conducted via structured telephone interviews.
Dual-Energy X-ray Absorptiometry (DXA)
Diagnostic testAll participants with a moderate/high fracture risk for osteoporosis will undergo Bone Mineral Density assessment by DXA, as well as a subsample of low fracture risk patients.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of Osteoporosis
Weighted proportion of the population screened (individuals aged between 40 and 90 years) diagnosed with osteoporosis by Dual-Energy X-ray Absorptiometry (T-score ≤ -2.5).
Secondary outcomes
Fracture Risk
Fracture risk assessment with the Portuguese-adapted FRAX®. Patients will be categorized in low fracture risk, moderate fracture risk and high fracture risk.
Prevalence of CKD-associated Osteoporosis
Proportion of individuals with CKD meeting osteoporosis diagnostic criteria
Creatinine
Serum levels of Creatinine (mg/dL)
eGFR
Estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation.
Other outcomes
Sclerostin
Serum levels of Sclerostin (pmol/L)
RANKL
Serum levels of RANKL (Receptor Activator of NF-KB Ligand) (pg/mL)
Osteoprotegerin
Serum levels of Osteoprotegerin (pg/mL)
FGF23
Serum levels of FGF23 (Fibroblast Growth Factor-23) (RU/mL)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade do Porto
Lead sponsor
ULS Barcelos/Esposende
Collaborator
This trial is not recruiting at the moment. You can still explore other options: