A study to determine serum periostin levels over a six month period in adult patients, following a fracture

A study to determine serum periostin levels over a six month period in adult patients, following a short or long bone fracture, or undergoing hip or knee joint replacement, or open reduction internal fixation surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000151639

Acronym

PER04

Enrollment

102

Registered

2014-02-07

Start date

2014-05-21

Completion date

2015-04-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Levels of POSTN (a protein-coding gene, also known as osteoblast specific factor) gene expression and periostin have been measured in a number of tissues and disease states and periostin has been shown to be present in the periosteum and periodontal ligament being critical for the formation and maintenance of bone and teeth. Levels of POSTN gene expression following fracture have been measured but as serum periostin levels have not been measured following bone fractures it is difficult to determine the clinical significance of increased POSTN gene expression. This study endeavours to measure the serum periostin levels in participants with small bone and large bone fractures and in participants undergoing hip or knee joint replacements to determine if there are clinically significant changes in periostin levels following a fracture.

Interventions

Serum Periostin levels Serum Periostin levels will be measured at 7 time points: Baseline (within 48 hours of fracture occuring), Week 1, Week 2, Week 4, Week 8, Week 12 and 6 months post baseline, via a specific periostin laboratory assay. For patients undergoing planned knee or hip joint replacement, an additional pre-operative sample will be taken at up to 3 months prior to Baseline

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Aged between 18 to 75 years Able to provide informed consent Experienced a fracture to short or long bone less than 48 hours prior, or undergoing hip or knee joint replacement, or or open reduction internal fixation (ORIF) surgery Participants will be enrolled to the following groups: 34 participants with a short-bone or phalangeal fracture 34 participants with a long bone fracture 34 participants undergoing hip or knee joint replacement surgery, or open reduction internal fixation (ORIF) surgery

Exclusion criteria

Doctor’s diagnosis of Asthma, Bronchitis or COPD Wheezing or use of respiratory inhalers in the past 12 months Known pregnancy Significant co morbidities (determined at investigator discretion) Hospital admission within last 3 months Surgery within last 3 months, determined at investigator discretion (this includes all major surgery requiring general anaesthetic, dental extractions and root canal procedures. This does not include minor procedures, including but not limited to mole or wart removal, dental fillings etc). Systemic Corticosteroids within the last 3 months Any other safety concern at the investigator’s discretion

Outcome results