Osteoporosis & Renal Disease: Research in Primary Health Care Services

NCT07848490 — Not yet recruiting, 622 participants, Universidade do Porto
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Osteoporosis & Renal Disease: Research in Primary Health Care Services - A Pilot Study

RegistryNCT07848490
StatusNot yet recruiting
Study typeObservational
Enrollment622 (Estimated)
SponsorUniversidade do Porto (Other); collaborators: ULS Barcelos/Esposende
ConditionsOsteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
InterventionsFracture risk assessment tool (FRAX), Dual-Energy X-ray Absorptiometry (DXA) (Diagnostic test)
Datesstart 2026-10-01 (estimated), primary completion 2027-09-30 (estimated), completion 2027-12-31 (estimated), first posted 2026-09-30, last updated 2026-09-30
Locations1 site in Portugal

Related Papers Related Patents Related Grants Related Experts
All trials for Osteoporosis All trials for Chronic Kidney Disease Mineral and Bone Disorder All trials of Fracture risk assessment tool (FRAX) All trials of Dual-Energy X-ray Absorptiometry (DXA)

-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.

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+Arms and interventions

  • 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.

+Outcome measures

Primary outcomes

  • Prevalence of Osteoporosis [Baseline]: 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 [Baseline]: 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 [Baseline and 3 months]: Proportion of individuals with CKD meeting osteoporosis diagnostic criteria
  • Creatinine [Baseline, 3 months and 12 months]: Serum levels of Creatinine (mg/dL)
  • eGFR [Baseline, 3 months and 12 months]: Estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation.
  • Calcium [Baseline and 12 months]: Serum levels of Calcium (mg/dL)
  • Phosphate [Baseline and 12 months]: Serum levels of phosphate (mg/dL)
  • Alkaline phosphatase [Baseline and 12 months]: Serum levels of Alkaline phosphatase (U/L)
  • 25-Hydroxyvitamin D [Baseline and 12 months]: Serum levels of 25-Hydroxyvitamin D (ng/mL)
  • Parathyroid Hormone [Baseline and 12 months]: Serum levels of Parathyroid Hormone (pg/mL)
  • P1NP [Baseline and 12 months]: Serum levels of N-terminal propeptide of type 1 procollagen (P1NP) (ng/mL)
  • CTX [Baseline and 12 months]: Serum levels of C-terminal cross-linked telopeptide of type 1 collagen (CTX) (pf/mL)
  • Health-related quality of life score (EQ-5D-5L) [Baseline and 12 months]: Quality of life evaluated using the EQ-5D-5L questionnaire, assessing disease control trajectories and comparing individuals with osteoporosis, with and without CKD.
  • Medication adherence score (ERAM-7) [Baseline and 12 months]: Adherence to pharmacological treatment evaluated using the scale "Escala de AutoReporte de Adesão à Medicação" (ERAM-7).

Other outcomes

  • Sclerostin [Baseline and 12 months]: Serum levels of Sclerostin (pmol/L)
  • RANKL [Baseline and 12 months]: Serum levels of RANKL (Receptor Activator of NF-KB Ligand) (pg/mL)
  • Osteoprotegerin [Baseline and 12 months]: Serum levels of Osteoprotegerin (pg/mL)
  • FGF23 [Baseline and 12 months]: Serum levels of FGF23 (Fibroblast Growth Factor-23) (RU/mL)

+Eligibility

Sex: All, ages: 40 Years to 90 Years

Inclusion Criteria:

* Age between 40 years and 90 years;
* Registered at participating Primary Healthcare Unit;
* Capable of providing informed consent.

Exclusion Criteria:

* Life expectancy <12 months;
* Severe cognitive/physical impairment;
* Inability to undergo DXA.

+Locations (1)

FacilityCityCountryStatus
ULS de Barcelos/EsposendeBarcelosPortugal