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

Active, not recruiting

• Conditions: Osteoarthritis; Osteogenesis Imperfecta; Rickets / Osteomalacia; Osteoporosis; Bone Infection
• Interventions: Device: spatially offset Raman spectrometer (SORS)

• Registration Number: NCT02814591
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 4: Patients with osteoporosis (OI)	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 6: Patients with rickets and osteomalacia	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.	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.
Cohort 1: Controls	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 5: Patients with osteoporosis (OP) (2 treatment groups)	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 2: Patients with ostegenesis imperfecta (OI).	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)	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.

Primary Outcome Measures

Name	Time	Method
SORS Raman spectral fingerprint for bone disease types and changes over time	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.