OsteoarthritisNCT02814591
Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
An observational study of Osteoarthritis and Osteoporosis, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Osteoporosis, Osteogenesis Imperfecta
- What is being tested?
- spatially offset Raman spectrometer (SORS)
- Type of treatment
- Medical device
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Control patients, patients with osteoarthritis, patients with osteoporosis, patients with osteogenesis imperfecta, patients with rickets or osteomalacia, patients with suspected bone infection.
Who may be able to join
- 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;
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- 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 diagnosis will be otherwise confirmed
- Where possible measurements will be acquired prior to the start of treatment and then for up to 4 follow up visits at flexible time points to allow scheduling to coincide with hospital appointments. The minimum time between visits should be 2 months.
- Cohort 5: 2x 30 patients with OP (two treatment groups):
- Patients must have been clinically diagnosed with OP;
- The first cohort will have been prescribed with bisphosphonate anti-resorptive treatment; the second with anabolic agents. Where treatment has ceased but remains active (long-acting), potential participants may be included at Dr. Keen's discretion.
- 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
- BMD confirmed with DXA
- Where possible measurements will be acquired prior to the start of treatment and then up to 4 follow up visits at flexible time points to allow scheduling to coincide with hospital appointments. Minimum time between visits should be 2 months.
- Cohort 6: 10-15 participants with rickets, 10-15 participants with osteomalacia
- Patients must have been clinically diagnosed with rickets/osteomalacia;
- Blood tests for 25-hydroxyvitamin D should be ≤25 nmol/L
- Once participants are on treatment a further measurement will be made 6 months afterwards
- Participants for rickets and osteomalacia groups will be recruited to give a total of 10 complete sets of data per group
- Cohort 7: 5 participants with a suspected bone infection
- Participants will have been diagnosed at RNOH with a suspected bone infection
- Participants will be scanned around the localised area of suspected infection. Measurements may also be taken away from the infection on the same side and the contralateral anatomical location e.g., if infection is suspected at the right knee then we may also scan further down the right leg and the left leg.
- Participants may have 1 or 2 visits; the latter to take place after all infection has cleared up. This is not subject to a fixed time frame.
- EXCLUSION CRITERIA In general smokers will be excluded. Ex-smokers will be included only if they gave up smoking a minimum of 5 years ago.
- Cohort 1: 40 volunteers, free from bone disease:
- A participant with a history of bone disease or non-accidental fracture
- Clinical features of bone disease
- Cohort 2: 40 patients with OI; Cohort 3: 40 patients with OA; Cohort 6: 20 patients with rickets/osteomalacia • Patients with more than 1 type of bone disease
- Cohorts 4, 5 and 6: receiving treatment
- Patients who have been advised to stop treatment. If the treatment is a long-acting one (i.e., will remain effective in the body) then the participant may be included.
Who cannot join
None listed.
About this study
Official title: Development of a Novel, Safe Method for the Non-invasive Assessment of Human Bone Quality, In Vivo, Using Spatially Offset Raman Spectroscopy
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.
- Conditions
- Osteoarthritis, Osteoporosis, Osteogenesis Imperfecta, Rickets / Osteomalacia, Bone Infection
- Being tested
- spatially offset Raman spectrometer (SORS)
- Medical subject headings
- Osteoarthritis, Osteoporosis, Osteogenesis Imperfecta, Rickets, Osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spatially offset Raman spectrometer (SORS)Device
Raman spectra will be collected non-invasively from patients using a lower power 830 nm laser. A probe is brought into gentle contact with the patients skin and measurements taken. The laser power has a pre-defined safe threshold of 30 mW into a 3.5 mm diameter aperture. Built in device safety features prevent this threshold from being exceeded. The probe that comes into patient contact is suitable for disinfecting.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Controls | 40 volunteers free from bone disease. No family histroy of osteogenesis imperfecta (OI). No history of non-accidental fracture. No history of osteoarthritis (OA) or clinical manifestations of disease. No clinical features of OI, OA or osteoporosis (OP). Normal haemoatology and biochemical blood screen. Controls will be gender and age matched (within five years) to the disease cohort patients. Children and adults both required. Receives: Device: spatially offset Raman spectrometer (SORS) | |
| Cohort 2: Patients with ostegenesis imperfecta (OI). | 40 patients with OI. Patients must have been clinically diagnosed with OI. Participants will be identified form the Royal National Orthopaedic Hospital, Metabolic Unit database. Bone mineral density (BMD) confirmed with DXA. Receives: Device: spatially offset Raman spectrometer (SORS) | |
| Cohort 3: Patients with osteoarthritis (OA) | 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. Receives: Device: spatially offset Raman spectrometer (SORS) | |
| Cohort 4: Patients with osteoporosis (OI) | 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 (RNOH), Metabolic Unit Database; if not from the RNOH then diagnosis will be otherwise confirmed. Receives: Device: spatially offset Raman spectrometer (SORS) | |
| Cohort 5: Patients with osteoporosis (OP) (2 treatment groups) | Patients must have been clinically diagnosed with OP. The first group will have been prescribed with bisphosphonate anti-resorptive treatment; the second with anabolic agents. Where possible participants will be identified from the Royal National Orthopaedic Hospital (RNOH), Metabolic Unit Database; if not from the RNOH then diagnosis will be otherwise confirmed. Bone mineral density (BMD) will be confirmed with DXA. Where possible measurements will be acquired prior to the start of treatment and then up to 4 follow up visits at flexible time points to allow scheduling to coincide with hospital appointments. Minimum time between vistis should be 2 months. Receives: Device: spatially offset Raman spectrometer (SORS) | |
| Cohort 6: Patients with rickets and osteomalacia | 10-15 participants with rickets and 10-15 participants with osteomalacia. Patients must have been clinically diagnosed with rickets/osteomalacia. Blood tests for 25-hydroxyvitamin D should be less than or equal to 25 nmol/L. Once participants are on treatment further measurements will be made 6 months afterwards. Participants for rickets and osteomalacia groups will be recruited to give a total of 10 complete sets of data per group. Receives: Device: spatially offset Raman spectrometer (SORS) | |
| Cohort 7: 5 patients with suspected bone infection. | Participants will have been diagnosed at RNOH with a suspected bone infection. Participants will be scanned around the localised area of suspected infection. Participants may have 1 or 2 vists; the latter to take place after all infection has cleared up. This is not subject to a fixed time frame. Receives: Device: spatially offset Raman spectrometer (SORS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SORS Raman spectral fingerprint for bone disease types and changes over time
Individual patient data will be pre-processed and extracted after patient participation visits. As cohorts are filled multivariate classification models will be built to validate disease discrimination and validation of the SORS technique.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startOct 2011
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 245 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust, Science & Technology Facilities Council
- Responsible party
- Sponsor
- Investigators
- Helen Birch, Professor, Principal investigator, UCLPanos Gikas, Consultant Rheumatologist, Principal investigator, Royal National Orthopaedic Hospital NHS Trust (RNOH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814591
- Sponsor's protocol ID
- 09/0423
- Status last verified
- Nov 2022
- First submitted
- 16 May 2016
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel, Safe Method for the Non-invasive Assessment of Human Bone Quality, In Vivo, Using Spatially Offset Raman Spectroscopy
- ClinicalTrials.gov ID
- NCT02814591
- Acronym / sponsor ID
- 09/0423
- Conditions
- Osteoarthritis, Osteoporosis, Osteogenesis Imperfecta, Rickets / Osteomalacia, Bone Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust, Science & Technology Facilities Council
- Study start
- Oct 2011
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Controls | – | Device: spatially offset Raman spectrometer (SORS)40 volunteers free from bone disease. No family histroy of osteogenesis imperfecta (OI). No history of non-accidental fracture. No history of osteoarthritis (OA) or clinical manifestations of disease. No clinical features of OI, OA or osteoporosis (OP). Normal haemoatology and biochemical blood screen. Controls will be gender and age matched (within five years) to the disease cohort patients. Children and adults both required. |
| Cohort 2: Patients with ostegenesis imperfecta (OI). | – | Device: spatially offset Raman spectrometer (SORS)40 patients with OI. Patients must have been clinically diagnosed with OI. Participants will be identified form the Royal National Orthopaedic Hospital, Metabolic Unit database. Bone mineral density (BMD) confirmed with DXA. |
| Cohort 3: Patients with osteoarthritis (OA) | – | Device: spatially offset Raman spectrometer (SORS)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. |
| Cohort 4: Patients with osteoporosis (OI) | – | Device: spatially offset Raman spectrometer (SORS)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 (RNOH), Metabolic Unit Database; if not from the RNOH then diagnosis will be otherwise confirmed. |
| Cohort 5: Patients with osteoporosis (OP) (2 treatment groups) | – | Device: spatially offset Raman spectrometer (SORS)Patients must have been clinically diagnosed with OP. The first group will have been prescribed with bisphosphonate anti-resorptive treatment; the second with anabolic agents. Where possible participants will be identified from the Royal National Orthopaedic Hospital (RNOH), Metabolic Unit Database; if not from the RNOH then diagnosis will be otherwise confirmed. Bone mineral density (BMD) will be confirmed with DXA. Where possible measurements will be acquired prior to the start of treatment and then up to 4 follow up visits at flexible time points to allow scheduling to coincide with hospital appointments. Minimum time between vistis should be 2 months. |
| Cohort 6: Patients with rickets and osteomalacia | – | Device: spatially offset Raman spectrometer (SORS)10-15 participants with rickets and 10-15 participants with osteomalacia. Patients must have been clinically diagnosed with rickets/osteomalacia. Blood tests for 25-hydroxyvitamin D should be less than or equal to 25 nmol/L. Once participants are on treatment further measurements will be made 6 months afterwards. Participants for rickets and osteomalacia groups will be recruited to give a total of 10 complete sets of data per group. |
| Cohort 7: 5 patients with suspected bone infection. | – | Device: spatially offset Raman spectrometer (SORS)Participants will have been diagnosed at RNOH with a suspected bone infection. Participants will be scanned around the localised area of suspected infection. Participants may have 1 or 2 vists; the latter to take place after all infection has cleared up. This is not subject to a fixed time frame. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Control patients, patients with osteoarthritis, patients with osteoporosis, patients with osteogenesis imperfecta, patients with rickets or osteomalacia, patients with suspected bone infection.
Key inclusion criteria (41 listed)
- 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;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| spatially offset Raman spectrometer (SORS)Raman spectra will be collected non-invasively from patients using a lower power 830 nm laser. A probe is brought into gentle contact with the patients skin and measurements taken. The laser power has a pre-defined safe threshold of 30 mW into a 3.5 mm diameter aperture. Built in device safety features prevent this threshold from being exceeded. The probe that comes into patient contact is suitable for disinfecting. | Device | Cohort 1: Controls, Cohort 2: Patients with ostegenesis imperfecta (OI)., Cohort 3: Patients with osteoarthritis (OA), Cohort 4: Patients with osteoporosis (OI), Cohort 5: Patients with osteoporosis (OP) (2 treatment groups), Cohort 6: Patients with rickets and osteomalacia, Cohort 7: 5 patients with suspected bone infection. |
Primary outcome
SORS Raman spectral fingerprint for bone disease types and changes over time
Time frame: 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.
Individual patient data will be pre-processed and extracted after patient participation visits. As cohorts are filled multivariate classification models will be built to validate disease discrimination and validation of the SORS technique.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Helen Birch, Professor principal investigator
UCL
Panos Gikas, Consultant Rheumatologist principal investigator
Royal National Orthopaedic Hospital NHS Trust (RNOH)
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Osteoporosis, run by University College, London.
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 41 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SORS Raman spectral fingerprint for bone disease types and changes over time (time frame: 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.). 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 23 Nov 2022.