The main objective is to assess the effects of environmental pollution risk factors on bone health in-vivo in patients with osteoporotic fractures. We hypothesize that higher levels of heavy metals, particularly lead, are detectable in some patients…
ID
Source
Brief title
Condition
- Fractures
- Environmental issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Risk effect estimate for lead in fracture case status.
- Mean levels of serum lead.
Secondary outcome
to assess whether other pollutants than the already described heavy metals are
also associated with worse bone health.
Background summary
Osteoporosis is a multifactorial common metabolic bone disease for which recent
studies postulate environmental pollution as an important but largely neglected
risk factor.
Bone accumulates up to 90% of heavy metal exposure and ex-vivo bone biopsy
studies have linked severely deranged skeletal microarchitecture and elevated
heavy metal concentrations in osteoporosis patients, possibly through hormone
disruption.
Advanced radiological imaging is the only non-invasive direct technology to
further evaluate bone in-vivo.
Study objective
The main objective is to assess the effects of environmental pollution risk
factors on bone health in-vivo in patients with osteoporotic fractures.
We hypothesize that higher levels of heavy metals, particularly lead, are
detectable in some patients with osteoporotic fractures compared to healthy
controls.
We will relate the levels of traces of environmental pollution in patients
compared to volunteers regarding imaging parameters of bone quality. Secondary
objectives will include to assess whether other pollutants than the already
described heavy metals are also associated with worse bone health.
Study design
Observational cohort study
Study burden and risks
Participants of this study will collect urine and feces, undergo sampling of
blood and hair.
Four questionnaires will be filled in at 1 time point, which will take
approximately 40 minutes.
The following radiological assessments will be performed at 1 timepoint:
- ultrasound of approximately 10 minutes,
- dual energy X-ray absorptiometry (DXA) bone mineral density measurement of
about 15 minutes,
- computed tomography (CT) of approximately 30 minutes
- and a MRI-scans of approximately 45 minutes.
All travel expenses made due to these visits will be reimbursed.
A potential risk of this study involves the X-ray radiation of the CT and DXA
scans. The estimated total dose will be 1.11 milliSievert (mSv), of which the
estimate from pQCT will be 0.01 mSv, from the photon counting CT 1.0 mSv and
the expected dose of the DXA scan will be 0.10 mSv, respectively.
Theoretically, X-ray exposure may have harmful health effects, but this risk is
low here with these doses. For subjects involved there is generally no expected
immediate direct benefit, except if imaging or environmental exposure
assessments yield findings that would be medically actionable.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76901.078.21 |