OsteoporosisNCT07848490
Osteoporosis & Renal Disease: Research in Primary Health Care Services
An observational study of Osteoporosis and Chronic Kidney Disease Mineral and Bone Disorder, run by Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
- What is being tested?
- Fracture risk assessment tool (FRAX) and Dual-Energy X-ray Absorptiometry (DXA)
- How many people
- 622 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adults aged 40 to 90 years registered at the Primary Healthcare Units of the ULS de Barcelos/Esposende
Who may be able to join
- Age between 40 years and 90 years;
- Registered at participating Primary Healthcare Unit;
- Capable of providing informed consent.
Who cannot join
- Life expectancy <12 months;
- Severe cognitive/physical impairment;
- Inability to undergo DXA.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlos Vaz, MD, PhD contact
Portugal1 site
ULS de Barcelos/Esposende
Barcelos, 4750-333
Juliana Magalhães, MD, +351 253 809 200, jcmagalhaes@ulsbe.min-saude.pt
About this study
Official title: Osteoporosis & Renal Disease: Research in Primary Health Care Services - A Pilot Study
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.
- Being tested
- Fracture risk assessment tool (FRAX), Dual-Energy X-ray Absorptiometry (DXA)
- Keywords
- Osteoporosis, Chronic Kidney Disease, Chronic Kidney Disease Mineral and Bone Disorder
- Medical subject headings
- Osteoporosis, Chronic Kidney Disease-Mineral and Bone Disorder, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (13)
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.
Measured: Baseline
Prevalence of CKD-associated Osteoporosis
Proportion of individuals with CKD meeting osteoporosis diagnostic criteria
Measured: Baseline and 3 months
Creatinine
Serum levels of Creatinine (mg/dL)
Measured: Baseline, 3 months and 12 months
eGFR
Estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation.
Measured: Baseline, 3 months and 12 months
Calcium
Serum levels of Calcium (mg/dL)
Measured: Baseline and 12 months
Phosphate
Serum levels of phosphate (mg/dL)
Measured: Baseline and 12 months
Alkaline phosphatase
Serum levels of Alkaline phosphatase (U/L)
Measured: Baseline and 12 months
25-Hydroxyvitamin D
Serum levels of 25-Hydroxyvitamin D (ng/mL)
Measured: Baseline and 12 months
Parathyroid Hormone
Serum levels of Parathyroid Hormone (pg/mL)
Measured: Baseline and 12 months
P1NP
Serum levels of N-terminal propeptide of type 1 procollagen (P1NP) (ng/mL)
Measured: Baseline and 12 months
CTX
Serum levels of C-terminal cross-linked telopeptide of type 1 collagen (CTX) (pf/mL)
Measured: Baseline and 12 months
Health-related quality of life score (EQ-5D-5L)
Quality of life evaluated using the EQ-5D-5L questionnaire, assessing disease control trajectories and comparing individuals with osteoporosis, with and without CKD.
Measured: Baseline and 12 months
Medication adherence score (ERAM-7)
Adherence to pharmacological treatment evaluated using the scale "Escala de AutoReporte de Adesão à Medicação" (ERAM-7).
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 622 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- ULS Barcelos/Esposende
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848490
- Sponsor's protocol ID
- OSTEO-CKD
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis & Renal Disease: Research in Primary Health Care Services - A Pilot Study
- ClinicalTrials.gov ID
- NCT07848490
- Acronym / sponsor ID
- OSTEO-CKD
- Keywords
- Osteoporosis, Chronic Kidney Disease, Chronic Kidney Disease Mineral and Bone Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 622 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- ULS Barcelos/Esposende
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adults aged 40 to 90 years registered at the Primary Healthcare Units of the ULS de Barcelos/Esposende
Key inclusion criteria (3 listed)
- Age between 40 years and 90 years;
- Registered at participating Primary Healthcare Unit;
- Capable of providing informed consent.
Key exclusion criteria (3 listed)
- Life expectancy <12 months;
- Severe cognitive/physical impairment;
- Inability to undergo DXA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
Prevalence of Osteoporosis
Time frame: 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).
13 secondary outcomes
Fracture Risk
Time frame: Baseline
Prevalence of CKD-associated Osteoporosis
Time frame: Baseline and 3 months
Creatinine
Time frame: Baseline, 3 months and 12 months
eGFR
Time frame: Baseline, 3 months and 12 months
Calcium
Time frame: Baseline and 12 months
Phosphate
Time frame: Baseline and 12 months
Alkaline phosphatase
Time frame: Baseline and 12 months
25-Hydroxyvitamin D
Time frame: Baseline and 12 months
Parathyroid Hormone
Time frame: Baseline and 12 months
P1NP
Time frame: Baseline and 12 months
CTX
Time frame: Baseline and 12 months
Health-related quality of life score (EQ-5D-5L)
Time frame: Baseline and 12 months
Medication adherence score (ERAM-7)
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Vaz, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Chronic Kidney Disease Mineral and Bone Disorder, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janete Santos, PhD (+351 220 426 569, sjanete@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Osteoporosis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.