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Vibration in Boys With a History of Fracture

Acute Bone Response to Vibration in Boys Who Have a History of Fracture

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04241432
Enrollment
20
Registered
2020-01-27
Start date
2012-02-29
Completion date
2017-09-30
Last updated
2020-01-28

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

Conditions

Fracture

Brief summary

Boys aged 9-12 years, with a history of facture will be asked to stand on one of two vibrating platforms for 10 minutes on 5 consecutive days. The investigators will take blood samples before and after the vibration to measure changes in the bone cells.

Detailed description

Fractures in children are common, accounting for 10% of attendances in Accident and Emergency Departments. Research into risk factors for fracture has found that children who have narrower bones and a low bone mass are more likely to fracture than children with larger bones. Studies in postmenopausal women, young women with low bone mass and children with disabling conditions such as cerebral palsy, have shown that up to 10 minutes a day stood on a vibrating platform can significantly increase bone mass. However little is known of the immediate response of bone to whole body vibration (WBV). The investigators previously investigated the acute bone response in healthy pre-pubertal boys to standing on one of two vibrating platforms for 10 minutes on 1, 3 or 5 consecutive days. This showed a platform dependent reduction in the bone resorption marker CTx pre to post vibration, with an increase in the bone formation marker P1NP over the 8 day study. The investigators would like to look at the response of bone to WBV in pre-pubertal boys who have a history of fracture(s). The investigators will compare this to the investigator's previous data to determine if bone in boys who have previously fractured responds in the same way as bone in boys who have not. The investigators plan to recruit 24 boys aged 9-12 years who have had a previous fracture to stand on one of two vibrating platforms for 10 minutes on 5 consecutive days. Before and after the period of vibration on days 1, 3, 5, and on days 8 and 12 the investigators will take a blood sample to measure changes in the bone cells. The boys will be asked about the amount of exercise they have participated in over the previous seven days. The findings of this study will be used to direct further research.

Interventions

DEVICEvibrating platform

Use of two different types of vibrating platform

Sponsors

Sheffield Children's NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
7 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* Caucasian * Aged 7-13yrs (pre-pubertal) * First language English * History of one or more fracture(s)

Exclusion criteria

* Pre-existing chronic illness * Known bone disease * Current or healing fracture * Recent (last 12 months) or current treatment likely to affect bone - this does not include inhaled or intermittent oral therapy with steroids for asthma * Balance problems * Continuing involvement in more than one other research study

Design outcomes

Primary

MeasureTime frameDescription
Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)68 monthsSerum bone turnover marker concentrations: P1NP and CTX (ng/ml)
Serum bone factor concentrations: OPG and sclerostin (pg/ml)68 monthsSerum bone factor concentrations: OPG and sclerostin (pg/ml)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026