Vibration in Boys With a History of Fracture
Acute Bone Response to Vibration in Boys Who Have a History of Fracture
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sheffield (South Yorkshire District)
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Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
- Sheffield Children's NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Platform type 1
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
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Use of two different types of vibrating platform
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ACTIVE_COMPARATOR: Platform type 2
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
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Use of two different types of vibrating platform
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)
Time Frame: 68 months
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Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)
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68 months
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Serum bone factor concentrations: OPG and sclerostin (pg/ml)
Time Frame: 68 months
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Serum bone factor concentrations: OPG and sclerostin (pg/ml)
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68 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Rachel Harrison, Investigator
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCH/11/061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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