NCT04241432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

5.6 years

First QC Date

April 18, 2018

Last Update Submit

January 24, 2020

Conditions

Fracture

Outcome Measures

Primary Outcomes (2)

  • Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)

    Serum bone turnover marker concentrations: P1NP and CTX (ng/ml)

    68 months

  • Serum bone factor concentrations: OPG and sclerostin (pg/ml)

    Serum bone factor concentrations: OPG and sclerostin (pg/ml)

    68 months

Study Arms (2)

Platform type 1

ACTIVE COMPARATOR

12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.

Device: vibrating platform

Platform type 2

ACTIVE COMPARATOR

12 pre-pubertal boys, aged 9-12 years who have previously sustained at least one fracture.

Device: vibrating platform

Interventions

vibrating platformDEVICE

Use of two different types of vibrating platform

Platform type 1Platform type 2

Eligibility Criteria

Age7 Years - 13 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Rachel Harrison

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

January 27, 2020

Study Start

February 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)