Vibration in Boys With a History of Fracture
Primary Purpose
Fracture
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
vibrating platform
Sponsored by
About this trial
This is an interventional basic science trial for Fracture
Eligibility Criteria
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
Sites / Locations
- Sheffield Children's NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Platform type 1
Platform type 2
Arm Description
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
Outcomes
Primary Outcome Measures
Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)
Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)
Serum bone factor concentrations: OPG and sclerostin (pg/ml)
Serum bone factor concentrations: OPG and sclerostin (pg/ml)
Secondary Outcome Measures
Full Information
NCT ID
NCT04241432
First Posted
April 18, 2018
Last Updated
January 24, 2020
Sponsor
Sheffield Children's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04241432
Brief Title
Vibration in Boys With a History of Fracture
Official Title
Acute Bone Response to Vibration in Boys Who Have a History of Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platform type 1
Arm Type
Active Comparator
Arm Description
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
Arm Title
Platform type 2
Arm Type
Active Comparator
Arm Description
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
Intervention Type
Device
Intervention Name(s)
vibrating platform
Intervention Description
Use of two different types of vibrating platform
Primary Outcome Measure Information:
Title
Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)
Description
Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)
Time Frame
68 months
Title
Serum bone factor concentrations: OPG and sclerostin (pg/ml)
Description
Serum bone factor concentrations: OPG and sclerostin (pg/ml)
Time Frame
68 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Harrison
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
State/Province
Sheffield (South Yorkshire District)
ZIP/Postal Code
S10 2TH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vibration in Boys With a History of Fracture
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