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Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02814591
Recruitment Status : Suspended
First Posted : June 28, 2016
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
Royal National Orthopaedic Hospital NHS Trust
Science & Technology Facilities Council
Information provided by (Responsible Party):
University College, London

Brief 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.

Condition or disease Intervention/treatment
Osteoarthritis Osteoporosis Osteogenesis Imperfecta Rickets / Osteomalacia Bone Infection Device: spatially offset Raman spectrometer (SORS)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 245 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Development of a Novel, Safe Method for the Non-invasive Assessment of Human Bone Quality, In Vivo, Using Spatially Offset Raman Spectroscopy
Study Start Date : October 2011
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025


Group/Cohort Intervention/treatment
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.
Device: 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.

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.
Device: 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.

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.
Device: 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.

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.
Device: 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.

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.
Device: 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.

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.
Device: 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.

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.
Device: 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Control patients, patients with osteoarthritis, patients with osteoporosis, patients with osteogenesis imperfecta, patients with rickets or osteomalacia, patients with suspected bone infection.
Criteria

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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814591


Sponsors and Collaborators
University College, London
Royal National Orthopaedic Hospital NHS Trust
Science & Technology Facilities Council
Investigators
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Principal Investigator: Helen Birch, Professor UCL
Principal Investigator: Panos Gikas, Consultant Rheumatologist Royal National Orthopaedic Hospital NHS Trust (RNOH)
Additional Information:

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02814591    
Other Study ID Numbers: 09/0423
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoporosis
Osteogenesis Imperfecta
Rickets
Osteomalacia
Musculoskeletal Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases
Osteochondrodysplasias
Bone Diseases, Developmental
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders