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

Recruiting

• Conditions: Osteoporosis; brittle bones; 10017322; 10014931

• Registration Number: NL-OMON51044
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

- 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Risk effect estimate for lead in fracture case status.<br /><br>- Mean levels of serum lead.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>to assess whether other pollutants than the already described heavy metals are<br /><br>also associated with worse bone health.</p><br>