Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spect… (NCT02814591) | Clinical Trial Compass
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Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
245 participantsStarted 2011-10
Plain-language summary
In this study spatially offset Raman spectroscopy (SORS), which allows the collection of Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.
Who can participate
Age range
0 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
Cohort 1: 40 volunteers, free from bone disease:
* Participants must be free from bone disease and not have a family history of OI;
* Participants to be age and sex matched with OP participants may be recruited among individuals attending the RNOH Metabolic Unit for DXA scanning, who are shown to have normal bone density T score\> -2.5;
* No history of non-accidental fracture;
* No history of OA or clinical manifestations of disease;
* No clinical features of OI;
* Controls will be sex and age matched (within five years) to the disease cohort patients.
* Children and adults both required
Cohort 2: 40 patients with OI:
* Patients must have been clinically diagnosed with OI;
* Where possible participants will be identified from the Royal National Orthopaedic Hospital, Metabolic Unit database; if not from RNOH then diagnosis will be otherwise confirmed
Cohort 3: 40 patients with OA:
* Patients must have been clinically diagnosed with OA;
* Participants will be identified from the Royal National Orthopaedic Hospital, Metabolic Unit database; if not from RNOH then diagnosis will be otherwise confirmed
Cohort 4: 40 patients with OI, receiving treatment with bisphosphonates:
* Patients must have been clinically diagnosed with OI and bisphosphonates prescribed as a course of treatment;
* 20 Adults and 20 children
* Where possible participants will be identified from the Royal National Orthopaedic Hospital, Metabolic Unit database; if not from RNOH then diag…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SORS Raman spectral fingerprint for bone disease types and changes over time
Timeframe: SORS Raman spectral features will be evaluated using a variety of multi-variate analytical tools e.g. BTEM at time zero and a repeat measure within a year.