NCT00961870

Brief Summary

This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density. If this hypothesis is valid, it can be firstly suggested that the relationship between bone mineral density and muscle strength is bidirectional. A total of 80 voluntaries are planned to include in this study. After forearm vibration is applied, bone mineral density (BMD) and bone mineral content (BMC) will be measured in all cases. Alpha motor neuron excitability (H/M ratio, recruitment), background muscle activity will be evaluated by electromyography at pre-treatment, post-treatment and, during treatment in cases. Forearm vibration will be applied by forearm vibration device (FAV). FAV with mechanical loading will apply forearm. Cases will sit on armchair. Two intervals of FAV will be applied at a frequency of 45 Hz. Each interval will consist of 60 second of FAV followed by rest. The right radius BMD and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO). Motor unite potentials at rest, Hoffman reflex, F response, M response will be measured by electromyography at right flexor carpi radialis. Medtronic Keypoint Portable 2 channel electromyography and Neurotrac ETS device will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

August 14, 2009

Last Update Submit

August 12, 2013

Conditions

Osteoporosis

Keywords

bonemotor neuron excitabilityforearm vibrationMechanical Loading

Outcome Measures

Primary Outcomes (1)

  • Changing alpha motor neuron excitability

    1-2 months

Study Arms (4)

Healthy postmenopausal women

EXPERIMENTAL

Forearm vibration will be applied in women without postmenopausal osteoporosis

Procedure: Forearm vibration

Osteoporotic postmenopausal women

EXPERIMENTAL

Forearm vibration will be applied in women with postmenopausal osteoporosis

Procedure: Forearm vibration

Healthy young adult women

EXPERIMENTAL

Forearm vibration will be applied in healthy young adult women

Procedure: Forearm vibration

Healthy young adult men

EXPERIMENTAL

Forearm vibration will be applied in healthy young adult men

Procedure: Forearm vibration

Interventions

Forearm vibrationPROCEDURE

Mechanical loading with forearm vibration will be applied right radius in all groups.

Also known as: Cyclic mechanical loading
Healthy postmenopausal womenHealthy young adult menHealthy young adult womenOsteoporotic postmenopausal women

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • females with postmenopausal osteoporosis (forearm BMD: T score \<-2.0)
  • females without postmenopausal osteoporosis (forearm BMD: T score \>-1.0)
  • healthy young adult females (forearm BMD normal)
  • healthy young adult males (forearm BMD normal)
  • cases with right handed patients in all groups

You may not qualify if:

  • secondary osteoporosis
  • neuropathy (central or peripheral)
  • myopathy
  • systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases)
  • professional sportswoman/sportsman
  • subjects doing regular sports activities
  • tendinopathy
  • amputee, endoprosthesis, metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakif Gureba Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • ILHAN KARACAN, MD

    Vakif Gureba Training & Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ILHAN KARACAN

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 19, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

TU(1)