Osteoporosis & Renal Disease: Research in Primary Health Care Services

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorUniversidade do Porto

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fracture risk assessment tool (FRAX)

    Diagnostic test

    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.

  • Dual-Energy X-ray Absorptiometry (DXA)

    Diagnostic test

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

Prevalence of CKD-associated Osteoporosis

Proportion of individuals with CKD meeting osteoporosis diagnostic criteria

Time frame
Baseline and 3 months
3

Creatinine

Serum levels of Creatinine (mg/dL)

Time frame
Baseline, 3 months and 12 months
4

eGFR

Estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation.

Time frame
Baseline, 3 months and 12 months

Other outcomes

1

Sclerostin

Serum levels of Sclerostin (pmol/L)

Time frame
Baseline and 12 months
2

RANKL

Serum levels of RANKL (Receptor Activator of NF-KB Ligand) (pg/mL)

Time frame
Baseline and 12 months
3

Osteoprotegerin

Serum levels of Osteoprotegerin (pg/mL)

Time frame
Baseline and 12 months
4

FGF23

Serum levels of FGF23 (Fibroblast Growth Factor-23) (RU/mL)

Time frame
Baseline and 12 months

Sponsors and contacts

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Universidade do Porto

Lead sponsor

ULS Barcelos/Esposende

Collaborator

This trial is not recruiting at the moment. You can still explore other options: