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NOT YET RECRUITING
NCT07848490

Osteoporosis & Renal Disease: Research in Primary Health Care Services

Sponsor: Universidade do Porto

View on ClinicalTrials.gov

Summary

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.

Official title: Osteoporosis & Renal Disease: Research in Primary Health Care Services - A Pilot Study

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

622

Start Date

2026-10-01

Completion Date

2027-12-31

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Fracture risk assessment tool (FRAX)

A 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.

DIAGNOSTIC_TEST

Dual-Energy X-ray Absorptiometry (DXA)

All 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.

Locations (1)

ULS de Barcelos/Esposende

Barcelos, Portugal