Bone Myoregulation Reflex in Senile Osteoporosis

May 8, 2025 updated by: Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Is the Bone Myoregulation Reflex Response to Weight-Bearing Activities Low in Senile Osteoporosis?

Osteoporosis is a systemic skeletal disease characterized by weakened and fragile bones. It often remains asymptomatic in its early stages but can lead to serious health problems, particularly fractures.The mechanostat theory explains that bone mass is regulated by mechanical loading. Increased activity stimulates bone formation, while decreased activity promotes bone resorption. The "bone reflex" concept further suggests that the nervous system plays a crucial role in this process by regulating both bone metabolism (osteoregulation) and muscle activity (myoregulation) in response to mechanical loading.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Objectives:Osteoporosis is a systemic skeletal disease characterized by weakened and fragile bone tissue. Typically asymptomatic in its early stages, it can lead to severe health consequences, particularly fractures. Bone mineral density (BMD) measurements, as defined by the World Health Organization, are considered the gold standard for diagnosing osteoporosis. The prevalence of osteoporosis is on the rise due to the aging population and the influence of lifestyle factors.

Recently, the bone reflex has been defined, suggesting that the central nervous system controls the local regulatory mechanisms described by Wolf and Frost. The bone reflex describes how osteocytes are stimulated by mechanical loading, leading to the neural regulation of bone formation and resorption according to mechanical needs (bone osteoregulation reflex). Additionally, it describes a mechanism by which the nervous system reflexively regulates the activity of surrounding muscles to optimally position the bone to resist applied mechanical load (bone myoregulation reflex).

Methods: This study employs a quasi-experimental design. The study will be conducted with a total of 22 patients aged 60-70, men. Diagnosis of osteoporosis was made according to the World Health Organization classification. Individuals with a T-score of -2.5 or below were classified as having osteoporosis. Participants will be divided into two groups: a group with osteoporosis (Group 1) and a group without osteoporosis (Group 2).

Procedures:

Bone myoregulation reflex activity of the soleus and tibialis anterior muscles will be assessed in both groups during whole-body vibration and jumping using surface electromyography.

  • Jumping Test: Participants will be instructed to jump in place 20 times, similar to rope skipping, with a 5-second rest interval between each jump.
  • Whole-Body Vibration: Participants will stand on the plate and undergo low-amplitude (1.2 mm) whole-body vibration at eight different frequencies (25, 27, 29, 31, 33, 35, 37, and 39 Hz) using a Powerplate Pro5 (Netherlands) device. Each vibration session will last for 10 seconds, with a 5-second rest interval between frequencies.
  • The Achilles tendon will be percussed 10 times with an electronic reflex hammer.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34186
        • Istanbul physical therapy rehabilitation training and research hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • DXA T-scores ≤-2.5 (osteoporotic) or T-scores > -1 (no bone loss)
  • Individuals who agree to participate in the study

Exclusion Criteria:

  • History of musculoskeletal surgery within the past year
  • Individuals with health conditions that severely affect mobility
  • Vestibular disorders
  • Visual impairments
  • Other rheumatic, psychiatric, or severe neurological diseases
  • Chronic decompensated cardiac, renal, or hepatic insufficiency
  • Panic attacks
  • Individuals with skin lesions on the soleus muscle
  • History of fractures or prostheses in the lower extremities
  • History of kidney stones
  • 2+ or more edema in the lower extremities, lymphedema
  • History of malignancy
  • History of osteomalacia or vitamin D deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Those with osteoporosis
Other: Whole-body vibration and Jumping
The subjects were first asked to jump in place 20 times, as if they were jumping rope. Then, whole-body vibration was applied. While the participants stood upright on the whole-body vibration device, low-amplitude (1.2 mm) vibrations were applied at eight different frequencies (25, 27, 29, 31, 33, 35, 37, 39 Hz), each lasting for 10 seconds, with a 5-second rest period in between. The Achilles tendon will be percussed 10 times with an electronic reflex hammer.
Experimental: Group 2
Those without osteoporosis
Other: Whole-body vibration and Jumping
The subjects were first asked to jump in place 20 times, as if they were jumping rope. Then, whole-body vibration was applied. While the participants stood upright on the whole-body vibration device, low-amplitude (1.2 mm) vibrations were applied at eight different frequencies (25, 27, 29, 31, 33, 35, 37, 39 Hz), each lasting for 10 seconds, with a 5-second rest period in between. The Achilles tendon will be percussed 10 times with an electronic reflex hammer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone myoregulation reflex latency
Time Frame: Through study completion, an average of 8 weeks.
The measurement will be taken as the time difference between the moment of mechanical stimulation and the onset of the reflex response in the EMG. The unit of measurement for latency is milliseconds.
Through study completion, an average of 8 weeks.
Bereitschafts (Readiness) Potential
Time Frame: Through study completion, an average of 8 weeks.
It refers to the myoelectric activity in the tibialis anterior and soleus muscles just before jumping. The onset time of this myoelectric activity will be evaluated in milliseconds, and the amplitude of this activity will be measured in millivolts.
Through study completion, an average of 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soleus H-reflex
Time Frame: Through study completion, an average of 8 weeks
The soleus T-reflex elicited by percussing the Achilles tendon with an electronic reflex hammer will be recorded using EMG. The unit of measurement for latency is milliseconds.
Through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH-EK2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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