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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

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.

Condition or disease Intervention/treatment Phase
Fracture Device: vibrating platform Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Bone Response to Vibration in Boys Who Have a History of Fracture
Study Start Date : February 2012
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Platform type 1
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
Device: vibrating platform
Use of two different types of vibrating platform

Active Comparator: Platform type 2
12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.
Device: vibrating platform
Use of two different types of vibrating platform




Primary Outcome Measures :
  1. Serum bone turnover marker concentrations: P1NP and CTX (ng/ml) [ Time Frame: 68 months ]
    Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)

  2. Serum bone factor concentrations: OPG and sclerostin (pg/ml) [ Time Frame: 68 months ]
    Serum bone factor concentrations: OPG and sclerostin (pg/ml)



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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241432


Locations
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United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
Investigators
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Principal Investigator: Rachel Harrison Investigator
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Responsible Party: Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04241432    
Other Study ID Numbers: SCH/11/061
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries