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

NCT02814591 | Unknown

• 1 other identifier: 09/0423
• Study Type: observational
• Target: 245
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis; Osteoporosis; Osteogenesis Imperfecta; Rickets / Osteomalacia; Bone Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (7)

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)

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)

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)

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)

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)

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)

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)

Interventions

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.

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.

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• Royal National Orthopaedic Hospital NHS Trust: collaborator
• Science & Technology Facilities Council: collaborator

MeSH Terms

Conditions

Osteoarthritis; Osteoporosis; Osteogenesis Imperfecta; Rickets; Osteomalacia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Helen Birch, Professor

  UCL

  PRINCIPAL INVESTIGATOR

• Panos Gikas, Consultant Rheumatologist

  Royal National Orthopaedic Hospital NHS Trust (RNOH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: June 28, 2016
• Study Start: October 1, 2011
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 23, 2022

Record last verified: 2022-11