Osteoporosis in Post-menopausal WomenNCT06687889
Effect of Muscle Stiffness on Vertebral Fractures in Women Over 60
An observational study of Osteoporosis in Post-menopausal Women and Vertebral Body Fractures, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to assess the quality of lumbar and abdominal core muscles through elastography and evaluate its impact on vertebral fracture risk. This tudy's secondary objective is to investigate the relationship between muscle quality, as measured by elastography, and balance and quality of life. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis in Post-menopausal Women, Vertebral Body Fractures, Balance, Postural
- What is being tested?
- Elastography Measurements, Bone Mineral Density Measurement (DEXA) and Berg balance scale
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2024to 15 May 2025
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female, aged ≥ 60 years
Who may be able to join
- Female, aged ≥ 60 years
Who cannot join
- History of lumbar spine surgery
- Cancer
- Spinal infection
- Severe degenerative scoliosis
- Chronic kidney failure
- Liver cirrhosis
- Bilateral hip arthroplasty
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Education and Research Hospital
Samsun, İlkadım, 55090
About this study
Official title: The Effect of Abdominal and Lumbar Muscle Stiffness Assessed by Elastography on Vertebral Fractures: A Cross-Sectional Study in Women Over 60
This study aims to assess the quality of lumbar and abdominal core muscles through elastography and evaluate its impact on vertebral fracture risk. This tudy's secondary objective is to investigate the relationship between muscle quality, as measured by elastography, and balance and quality of life.
The fundamental questions that this study aims to answer are as follows:
Does the quality of lumbar and abdominal core muscles, as assessed by elastography, affect the risk of vertebral fractures? Is there a relationship between muscle quality (as measured by elastography) and balance and quality of life in older adults?
Read the detailed description
Osteoporosis, a systemic bone disease marked by reduced bone mass and deteriorating bone structure, increases fracture risk, especially in the spine. Vertebral fractures, most common in the lower thoracic and upper lumbar regions, can impair motor function, limit daily activities, and raise disability and mortality risks. With aging, decreasing bone mineral density (BMD) and muscle quality contribute to structural changes like kyphosis and lordosis, further reducing balance and increasing fracture risk. While DEXA remains the standard for BMD assessment, ultrasound (USG) and shear wave elastography (SWE) offer non-invasive imaging for muscle quality without radiation exposure. Despite muscle degeneration's impact on spinal stability, most osteoporosis studies focus on bones, with few examining muscles. Recognizing this gap, our study uses elastography to assess lumbar and abdominal muscle quality and its impact on vertebral fracture risk, while also exploring the relationship between muscle quality, balance, and quality of life in older adults.
- Being tested
- Elastography Measurements, Bone Mineral Density Measurement (DEXA), Berg balance scale, Functional reach test, Timed Up and Go Test
- Keywords
- vertebral fractures, osteoporosis, abdominal muscles
- Medical subject headings
- Spinal Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastography MeasurementsOther
Elastography Measurements
Bone Mineral Density Measurement (DEXA)Other
Bone Mineral Density Measurement (DEXA)
Berg balance scaleOther
Berg balance scale
Functional reach testOther
Functional reach test
Timed Up and Go TestOther
Timed Up and Go Test
| Study group | Role | What they receive |
|---|---|---|
| vertebral fractures group | vertebral fractures group Receives: Other: Elastography Measurements; Other: Bone Mineral Density Measurement (DEXA); Other: Berg balance scale; Other: Functional reach test; Other: Timed Up and Go Test | |
| non vertebral fractures group | non vertebral fractures group Receives: Other: Elastography Measurements; Other: Bone Mineral Density Measurement (DEXA); Other: Berg balance scale; Other: Functional reach test; Other: Timed Up and Go Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastography Measurements
Measurements were performed using a Mindray ultrasound device (Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen, China) with a 15-3 MHz linear probe in Shear Wave Elastography mode. Ultrasound gel was applied between the probe and the skin to enhance contact. The probe was positioned in line with the muscle fibers and perpendicular to the skin, allowing 2D maps of each muscle's shear modulus to be obtained with a spatial resolution of 1 mm and a sampling rate of 1 sample per second. Images obtained during elastography measurements were analyzed using Q-Box to evaluate Young's modulus (kPa) and SWW (m/s). Shear modulus measurements were taken at rest and at the end of contraction. Muscle thickness measurements were recorded in mm by measuring the distance between the two fascias. All measurements were performed three times, and the average of these measurements will be used for statistical analysis
Measured: 8 weeks
Secondary outcomes (4)
Bone Mineral Density Measurement (DEXA)
All participants will undergo bone mineral density (BMD) measurements of the lumbar vertebrae (L1-L4) and left proximal femur (femur neck) at the same center using dual-energy X-ray absorptiometry (DEXA; HOLOGIC, QDR 2000, EXPLORER S1N 90910). Currently, DEXA is the standard method for diagnosing osteoporosis. Osteoporosis and osteopenia are defined according to the criteria set by the World Health Organization (WHO) for postmenopausal women: T-scores of -2.5 or lower indicate osteoporosis, while T-scores between -1.0 and -2.49 represent osteopenia. The T-score reflects bone mass by comparing it to that of a younger individual of the same sex with peak bone mass
Measured: 8 weeks
Berg balance scale
The Berg Balance Scale is a test with proven reliability and validity in Turkish, used to assess balance in the elderly. It consists of 14 items, each scored from 0 to 4 based on observed performance. The maximum score is 56, where 0-20 points indicate balance impairment, 21-40 points suggest acceptable balance, and 41-56 points reflect good balance.
Measured: 8 weeks
Functional Reach Test
The Functional Reach Test is a reliable and valid measure of anterior stability . The patient stands close to, but not touching, a wall with their arm extended forward at 90° flexion and fist closed. The evaluator marks the position of the third metacarpal head on the wall. The patient is then asked to reach forward as far as possible without stepping. The evaluator marks the new position of the third metacarpal head, and the difference between the initial and final marks is measured using a tape measure. Three trials are conducted, and the average is recorded. A reach of 15 cm or less indicates a significantly increased fall risk, while 15-25 cm indicates a moderate fall risk.
Measured: 8 weeks
Timed Up and Go Test
This test, with proven reliability and validity, assesses fall risk in the elderly population. The patient is given verbal instructions to stand up from a chair, walk 3 meters following a marked line on the floor as quickly and safely as possible, turn, walk back, and sit down. Times are interpreted as follows: 10 seconds or less-patient walks independently with very low fall risk; 11-19 seconds-patient walks independently with low to moderate fall risk; 20-29 seconds-patient may occasionally need assistance, with moderate to high fall risk; over 30 seconds-patient often needs assistance and has a high fall risk.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start24 Nov 2024
- Primary completion15 Jan 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis in Post-menopausal WomenStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Samsun Education and Research Hospital
- Responsible party
- Principal investigator, Handan Elif Nur BAYRAKTAR, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687889
- Sponsor's protocol ID
- Samsun-PMR-DRHENY-01
- Status last verified
- Aug 2025
- First submitted
- 10 Nov 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koppenhaver SL, Scutella D, Sorrell BA, Yahalom J, Fernandez-de-Las-Penas C, Childs JD, Shaffer SW, Shinohara M. Normative parameters and anthropometric variability of lumbar muscle stiffness using ultrasound shear-wave elastography. Clin Biomech (Bristol). 2019 Feb;62:113-120. doi: 10.1016/j.clinbiomech.2019.01.010. Epub 2019 Jan 30.
PubMed 30721824MacDonald D, Wan A, McPhee M, Tucker K, Hug F. Reliability of Abdominal Muscle Stiffness Measured Using Elastography during Trunk Rehabilitation Exercises. Ultrasound Med Biol. 2016 Apr;42(4):1018-25. doi: 10.1016/j.ultrasmedbio.2015.12.002. Epub 2015 Dec 30.
PubMed 26746381Koppenhaver SL, Weaver AM, Randall TL, Hollins RJ, Young BA, Hebert JJ, Proulx L, Fernandez-de-Las-Penas C. Effect of dry needling on lumbar muscle stiffness in patients with low back pain: A double blind, randomized controlled trial using shear wave elastography. J Man Manip Ther. 2022 Jun;30(3):154-164. doi: 10.1080/10669817.2021.1977069. Epub 2021 Sep 16.
PubMed 34525901Lems WF, Paccou J, Zhang J, Fuggle NR, Chandran M, Harvey NC, Cooper C, Javaid K, Ferrari S, Akesson KE; International Osteoporosis Foundation Fracture Working Group. Vertebral fracture: epidemiology, impact and use of DXA vertebral fracture assessment in fracture liaison services. Osteoporos Int. 2021 Mar;32(3):399-411. doi: 10.1007/s00198-020-05804-3. Epub 2021 Jan 21.
PubMed 33475820Ciloglu O, Karaali E, Gorgulu FF, Ekiz T. Diaphragm thickness and stiffness in patients with hyperkyphosis due to osteoporotic vertebral fracture: an ultrasonographic and elastographic study. Pol J Radiol. 2020 Oct 5;85:e575-e580. doi: 10.5114/pjr.2020.99751. eCollection 2020.
PubMed 33204371Hug F, Tucker K, Gennisson JL, Tanter M, Nordez A. Elastography for Muscle Biomechanics: Toward the Estimation of Individual Muscle Force. Exerc Sport Sci Rev. 2015 Jul;43(3):125-33. doi: 10.1249/JES.0000000000000049.
PubMed 25906424Bedewi MA, Elsifey AA, Alfaifi T, Saleh AK, Swify SM, Sandougah KJ. Shearwave elastography of the Sartorius muscle. Medicine (Baltimore). 2021 Mar 19;100(11):e25196. doi: 10.1097/MD.0000000000025196.
PubMed 33726013Lee DG, Bae JH. Fatty infiltration of the multifidus muscle independently increases osteoporotic vertebral compression fracture risk. BMC Musculoskelet Disord. 2023 Jun 22;24(1):508. doi: 10.1186/s12891-023-06640-2.
PubMed 37349814Jeon I, Kim SW, Yu D. Paraspinal muscle fatty degeneration as a predictor of progressive vertebral collapse in osteoporotic vertebral compression fractures. Spine J. 2022 Feb;22(2):313-320. doi: 10.1016/j.spinee.2021.07.020. Epub 2021 Jul 31.
PubMed 34343666Luo Y, Yue W, Li Z, Chen L, Wang P, Sun K. An initial study of core muscles using ultrasound in postmenopausal women with osteoporosis. Ann Palliat Med. 2022 Apr;11(4):1482-1490. doi: 10.21037/apm-22-314.
PubMed 35523756Ozmen T, Gafuroglu U, Aliyeva A, Elverici E. Relationship between core stability and dynamic balance in women with postmenopausal osteoporosis. Turk J Phys Med Rehabil. 2017 Oct 6;64(3):239-245. doi: 10.5606/tftrd.2018.1674. eCollection 2018 Sep.
PubMed 31453517
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal and Lumbar Muscle Stiffness Assessed by Elastography on Vertebral Fractures: A Cross-Sectional Study in Women Over 60
- ClinicalTrials.gov ID
- NCT06687889
- Acronym / sponsor ID
- Samsun-PMR-DRHENY-01
- Keywords
- vertebral fractures, osteoporosis, abdominal muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Samsun Education and Research Hospital
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 14 Nov 2024 (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.
This study aims to assess the quality of lumbar and abdominal core muscles through elastography and evaluate its impact on vertebral fracture risk. This tudy's secondary objective is to investigate the relationship between muscle quality, as measured by elastography, and balance and quality of life.
The fundamental questions that this study aims to answer are as follows:
Does the quality of lumbar and abdominal core muscles, as assessed by elastography, affect the risk of vertebral fractures? Is there a relationship between muscle quality (as measured by elastography) and balance and quality of life in older adults?
Detailed description
Osteoporosis, a systemic bone disease marked by reduced bone mass and deteriorating bone structure, increases fracture risk, especially in the spine. Vertebral fractures, most common in the lower thoracic and upper lumbar regions, can impair motor function, limit daily activities, and raise disability and mortality risks. With aging, decreasing bone mineral density (BMD) and muscle quality contribute to structural changes like kyphosis and lordosis, further reducing balance and increasing fracture risk. While DEXA remains the standard for BMD assessment, ultrasound (USG) and shear wave elastography (SWE) offer non-invasive imaging for muscle quality without radiation exposure. Despite muscle degeneration's impact on spinal stability, most osteoporosis studies focus on bones, with few examining muscles. Recognizing this gap, our study uses elastography to assess lumbar and abdominal muscle quality and its impact on vertebral fracture risk, while also exploring the relationship between muscle quality, balance, and quality of life in older adults.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vertebral fractures group | – | Other: Elastography Measurements, Other: Bone Mineral Density Measurement (DEXA), Other: Berg balance scale, Other: Functional reach test, Other: Timed Up and Go Testvertebral fractures group |
| non vertebral fractures group | – | Other: Elastography Measurements, Other: Bone Mineral Density Measurement (DEXA), Other: Berg balance scale, Other: Functional reach test, Other: Timed Up and Go Testnon vertebral fractures group |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female, aged ≥ 60 years
Key inclusion criteria (1 listed)
- Female, aged ≥ 60 years
Key exclusion criteria (7 listed)
- History of lumbar spine surgery
- Cancer
- Spinal infection
- Severe degenerative scoliosis
- Chronic kidney failure
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 |
|---|---|---|
| Elastography MeasurementsElastography Measurements | Other | non vertebral fractures group, vertebral fractures group |
| Bone Mineral Density Measurement (DEXA)Bone Mineral Density Measurement (DEXA) | Other | non vertebral fractures group, vertebral fractures group |
| Berg balance scaleBerg balance scale | Other | non vertebral fractures group, vertebral fractures group |
| Functional reach testFunctional reach test | Other | non vertebral fractures group, vertebral fractures group |
| Timed Up and Go TestTimed Up and Go Test | Other | non vertebral fractures group, vertebral fractures group |
Primary outcome
Elastography Measurements
Time frame: 8 weeks
Measurements were performed using a Mindray ultrasound device (Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen, China) with a 15-3 MHz linear probe in Shear Wave Elastography mode. Ultrasound gel was applied between the probe and the skin to enhance contact. The probe was positioned in line with the muscle fibers and perpendicular to the skin, allowing 2D maps of each muscle's shear modulus to be obtained with a spatial resolution of 1 mm and a sampling rate of 1 sample per second. Images obtained during elastography measurements were analyzed using Q-Box to evaluate Young's modulus (kPa) and SWW (m/s). Shear modulus measurements were taken at rest and at the end of contraction. Muscle thickness measurements were recorded in mm by measuring the distance between the two fascias. All measurements were performed three times, and the average of these measurements will be used for statistical analysis
4 secondary outcomes
Bone Mineral Density Measurement (DEXA)
Time frame: 8 weeks
Berg balance scale
Time frame: 8 weeks
Functional Reach Test
Time frame: 8 weeks
Timed Up and Go Test
Time frame: 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 28 Aug 2025.
- Results publication: PubMed 30721824Koppenhaver SL, Scutella D, Sorrell BA, Yahalom J, Fernandez-de-Las-Penas C, Childs JD, Shaffer SW, Shinohara M. Normative parameters and anthropometric variability of lumbar muscle stiffness using ultrasound shear-wave elastography. Clin Biomech (Bristol). 2019 Feb;62:113-120. doi: 10.1016/j.clinbiomech.2019.01.010. Epub 2019 Jan 30.
- Results publication: PubMed 26746381MacDonald D, Wan A, McPhee M, Tucker K, Hug F. Reliability of Abdominal Muscle Stiffness Measured Using Elastography during Trunk Rehabilitation Exercises. Ultrasound Med Biol. 2016 Apr;42(4):1018-25. doi: 10.1016/j.ultrasmedbio.2015.12.002. Epub 2015 Dec 30.
- Results publication: PubMed 34525901Koppenhaver SL, Weaver AM, Randall TL, Hollins RJ, Young BA, Hebert JJ, Proulx L, Fernandez-de-Las-Penas C. Effect of dry needling on lumbar muscle stiffness in patients with low back pain: A double blind, randomized controlled trial using shear wave elastography. J Man Manip Ther. 2022 Jun;30(3):154-164. doi: 10.1080/10669817.2021.1977069. Epub 2021 Sep 16.
- Results publication: PubMed 33475820Lems WF, Paccou J, Zhang J, Fuggle NR, Chandran M, Harvey NC, Cooper C, Javaid K, Ferrari S, Akesson KE; International Osteoporosis Foundation Fracture Working Group. Vertebral fracture: epidemiology, impact and use of DXA vertebral fracture assessment in fracture liaison services. Osteoporos Int. 2021 Mar;32(3):399-411. doi: 10.1007/s00198-020-05804-3. Epub 2021 Jan 21.
- Results publication: PubMed 33204371Ciloglu O, Karaali E, Gorgulu FF, Ekiz T. Diaphragm thickness and stiffness in patients with hyperkyphosis due to osteoporotic vertebral fracture: an ultrasonographic and elastographic study. Pol J Radiol. 2020 Oct 5;85:e575-e580. doi: 10.5114/pjr.2020.99751. eCollection 2020.
- Results publication: PubMed 25906424Hug F, Tucker K, Gennisson JL, Tanter M, Nordez A. Elastography for Muscle Biomechanics: Toward the Estimation of Individual Muscle Force. Exerc Sport Sci Rev. 2015 Jul;43(3):125-33. doi: 10.1249/JES.0000000000000049.
- Results publication: PubMed 33726013Bedewi MA, Elsifey AA, Alfaifi T, Saleh AK, Swify SM, Sandougah KJ. Shearwave elastography of the Sartorius muscle. Medicine (Baltimore). 2021 Mar 19;100(11):e25196. doi: 10.1097/MD.0000000000025196.
- Results publication: PubMed 37349814Lee DG, Bae JH. Fatty infiltration of the multifidus muscle independently increases osteoporotic vertebral compression fracture risk. BMC Musculoskelet Disord. 2023 Jun 22;24(1):508. doi: 10.1186/s12891-023-06640-2.
- Results publication: PubMed 34343666Jeon I, Kim SW, Yu D. Paraspinal muscle fatty degeneration as a predictor of progressive vertebral collapse in osteoporotic vertebral compression fractures. Spine J. 2022 Feb;22(2):313-320. doi: 10.1016/j.spinee.2021.07.020. Epub 2021 Jul 31.
- Results publication: PubMed 35523756Luo Y, Yue W, Li Z, Chen L, Wang P, Sun K. An initial study of core muscles using ultrasound in postmenopausal women with osteoporosis. Ann Palliat Med. 2022 Apr;11(4):1482-1490. doi: 10.21037/apm-22-314.
- Results publication: PubMed 31453517Ozmen T, Gafuroglu U, Aliyeva A, Elverici E. Relationship between core stability and dynamic balance in women with postmenopausal osteoporosis. Turk J Phys Med Rehabil. 2017 Oct 6;64(3):239-245. doi: 10.5606/tftrd.2018.1674. eCollection 2018 Sep.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Osteoporosis in Post-menopausal Women and Vertebral Body Fractures, run by Ankara City Hospital Bilkent 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 1 inclusion and 7 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 28 Aug 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?
Elastography Measurements (time frame: 8 weeks). 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 NCT06687889, which also lists 11 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 28 Aug 2025.