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Vibration in Boys With a History of Fracture

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ClinicalTrials.gov Identifier: NCT04241432
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date January 28, 2020
Study Start Date  ICMJE February 2012
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Serum bone turnover marker concentrations: P1NP and CTX (ng/ml) [ Time Frame: 68 months ]
    Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)
  • Serum bone factor concentrations: OPG and sclerostin (pg/ml) [ Time Frame: 68 months ]
    Serum bone factor concentrations: OPG and sclerostin (pg/ml)
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • Pre to post whole body vibration (WBV) response of the bone turnover markers P1NP and CTX in boys who have a history of having sustained at least one fracture [ Time Frame: 68 months ]
    The primary aim of this study is to capture the acute response of bone, using the bone formation marker P1NP and bone resorption marker CTX following 10 minutes whole body vibration (WBV) on 5 consecutive days in boys who have a history of having sustained at least one fracture
  • Pre to post whole body vibration (WBV) response of OPG and sclerostin in boys who have a history of having sustained at least one fracture [ Time Frame: 68 months ]
    The primary aim of this study is to capture the acute response of bone, using the bone factors OPG and sclerostin following 10 minutes whole body vibration (WBV) on 5 consecutive days in boys who have a history of having sustained at least one fracture
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
Response of bone turnover markers P1NP and CTX, bone factors OPG and sclerostin, at day 8, in boys with a history of fracture exposed to short term WBV, will be compared to those who have not previously fractured, to see if the responses are different [ Time Frame: 68 months ]
Following 5 consecutive days of whole body vibration, bone turnover markers P1NP and CTX, and other bone factors, OPG and sclerostin, will be compared to see if the response is the same in boys with a history of fracture and those without
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vibration in Boys With a History of Fracture
Official Title  ICMJE Acute Bone Response to Vibration in Boys Who Have a History of 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Fracture
Intervention  ICMJE Device: vibrating platform
Use of two different types of vibrating platform
Study Arms  ICMJE
  • Active Comparator: Platform type 1
    12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
    Intervention: Device: vibrating platform
  • Active Comparator: Platform type 2
    12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
    Intervention: Device: vibrating platform
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2020)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 7 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04241432
Other Study ID Numbers  ICMJE SCH/11/061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sheffield Children's NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Children's NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachel Harrison Investigator
PRS Account Sheffield Children's NHS Foundation Trust
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP