Osteoporosis (Senile)NCT06786195
Bone Myoregulation Reflex in Senile Osteoporosis
A study testing Whole-body vibration and Jumping in people with Osteoporosis (Senile), run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 70 years, men only
- Conditions the study is for
- Osteoporosis (Senile)
- What is being tested?
- Whole-body vibration and Jumping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DXA T-scores ≤-2.5 (osteoporotic) or T-scores > -1 (no bone loss)
- Individuals who agree to participate in the study
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Therapy Rehabilitation Training and Research Hospital
Istanbul, 34186
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis (Senile)
- Being tested
- Whole-body vibration and Jumping
- Keywords
- Reflex, Vibration, Bone, Loading exercise, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibration and JumpingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Those with osteoporosis Receives: Other: Whole-body vibration and Jumping |
| Group 2 | Experimental | Those without osteoporosis Receives: Other: Whole-body vibration and Jumping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone myoregulation reflex latency
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.
Measured: Through study completion, an average of 8 weeks.
Bereitschafts (Readiness) Potential
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.
Measured: Through study completion, an average of 8 weeks.
Secondary outcomes (1)
Soleus H-reflex
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.
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start15 Feb 2025
- Primary completion15 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis (Senile)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a quasi-experimental design. 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).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786195
- Sponsor's protocol ID
- IstPRMTRH-EK2
- Status last verified
- May 2025
- First submitted
- 9 Jan 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kalaoglu E, Faruk Bucak O, Kokce M, Ozkan M, Cetin M, Atasoy M, Ayture L, Karacan I. High-frequency whole-body vibration activates tonic vibration reflex. Turk J Phys Med Rehabil. 2023 Jan 11;69(1):46-51. doi: 10.5606/tftrd.2023.10854. eCollection 2023 Mar.
PubMed 37201009Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
PubMed 11018445Kilic A, Soyturk G, Karaoglu A, Topkara Arslan B, Karacan I, Turker KS. A reliability study on the cumulative averaging method for estimating effective stimulus time in vibration studies. J Electromyogr Kinesiol. 2023 Jun;70:102768. doi: 10.1016/j.jelekin.2023.102768. Epub 2023 Mar 20.
PubMed 36965288Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
PubMed 25100978Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2026 Jan;604(2):672-688. doi: 10.1113/JP285666. Epub 2024 Aug 9.
PubMed 39119811Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. doi: 10.1007/BF01622200.
PubMed 7696835
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Bone Myoregulation Reflex Response to Weight-Bearing Activities Low in Senile Osteoporosis?
- ClinicalTrials.gov ID
- NCT06786195
- Acronym / sponsor ID
- IstPRMTRH-EK2
- Conditions
- Osteoporosis (Senile)
- Keywords
- Reflex, Vibration, Bone, Loading exercise, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a quasi-experimental design. 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Whole-body vibration and JumpingThose with osteoporosis |
| Group 2 | Experimental | Other: Whole-body vibration and JumpingThose without osteoporosis |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DXA T-scores ≤-2.5 (osteoporotic) or T-scores > -1 (no bone loss)
- Individuals who agree to participate in the study
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body vibration and JumpingThe 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. | Other | Group 1, Group 2 |
Primary outcome
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.
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.
1 secondary outcome
Soleus H-reflex
Time frame: Through study completion, an average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Results publication: PubMed 37201009Kalaoglu E, Faruk Bucak O, Kokce M, Ozkan M, Cetin M, Atasoy M, Ayture L, Karacan I. High-frequency whole-body vibration activates tonic vibration reflex. Turk J Phys Med Rehabil. 2023 Jan 11;69(1):46-51. doi: 10.5606/tftrd.2023.10854. eCollection 2023 Mar.
- Results publication: PubMed 11018445Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
- Results publication: PubMed 36965288Kilic A, Soyturk G, Karaoglu A, Topkara Arslan B, Karacan I, Turker KS. A reliability study on the cumulative averaging method for estimating effective stimulus time in vibration studies. J Electromyogr Kinesiol. 2023 Jun;70:102768. doi: 10.1016/j.jelekin.2023.102768. Epub 2023 Mar 20.
- Results publication: PubMed 25100978Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
- Results publication: PubMed 39119811Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2026 Jan;604(2):672-688. doi: 10.1113/JP285666. Epub 2024 Aug 9.
- Results publication: PubMed 7696835Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. doi: 10.1007/BF01622200.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body vibration and Jumping in people with Osteoporosis (Senile), run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone myoregulation reflex latency (time frame: Through study completion, an average of 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786195, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.