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Osteoporosis Environmental Exposomics and Radiology Imaging Study: a case-control study*

Osteoporosis Environmental Exposomics and Radiology Imaging Study: a case-control study* - Osteoporosis Exposomics and Imaging

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51044
Enrollment
200
Registered
2021-08-16
Start date
2023-02-18
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 50 years - To be adequately ambulatory to undergo all imaging and complete the research visits - Sufficient command of the Dutch language - Be legally competent to understand informed consent For disease cases, in addition: - A history of a bone fragility fracture within the past 2 years but preferably within the last six months diagnosed by radiological imaging

Exclusion criteria

Exclusion criteria: - Patients from whom no written informed consent was obtained - Fractures of the skull, toes, or fingers - Fracture by high-trauma mechanism (particularly trauma injury severity score [ISS] >16), such as those including motorized traffic accidents or falls from more than 2 meters height - Pathological fractures associated with primary or metastatic bone tumors - Periprosthetic fractures - Fractures associated with other bone diseases (e.g., Paget*s Disease, fibrous dysplasia) - Women who are pregnant or lactating - Participants cannot undergo MRI scans if they have in their body: a pacemaker, valve prosthesis, certain shunts or certain metals. Persons with a joint prosthesis can mostly undergo MRI scans. These participants can still participate in the remainder of the study For matched controls, in addition: - Treatment with medications known to significantly affect bone metabolism in the last year or for >12 months ever, including: hormonal replacement therapy (testosterone or high-dose estrogen), anti-androgens or anti-estrogens, bisphosphonates, teriparatide, denosumab, use of prednisone >7.5 mg daily or the equivalent glucocorticoid for >10 days. - A history of fractures after age 50 years or in the preceding 5 years

Design outcomes

Primary

MeasureTime frame
- Risk effect estimate for lead in fracture case status. - Mean levels of serum lead.

Secondary

MeasureTime frame
to assess whether other pollutants than the already described heavy metals are also associated with worse bone health.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)