OsteoporosisNCT03280693
Relationships Among Body Mass Index, Body Balance and Bone Mineral Density in Postmenopausal Women
An observational study of Osteoporosis and Fall Patients, run by Cairo University.
Trial summary
Body composition, bone mineral density (BMD), and body balance are important factors that threaten postural control. They act as vital elements in the vicious circle that leads to fracture occurrence in elderly population, particularly postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Osteoporosis, Fall Patients, Postmenopausal Disorder
- What is being tested?
- Diagnostic test
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Nov 2015
- 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 50 to 60 years
- Women only
- Adult
Study population: Forty-eight postmenopausal women participated in this study. Their mean values of age, body mass, height, and BMI were 53.5 ± 2.75 y, 89.08 ± 12.3 Kg, 159.67.8 ± 2.54 cm, and 34.89 ± 4.89 Kg/m², respectively. Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.
Who may be able to join
- postmenopausal women with ages range from 50 to 60 years
Who cannot join
- participation in sports
- vertebrobasillar insufficiency
- poor diet
About this study
Official title: Relationships Among Body Mass Index, Body Balance and Bone Mineral Density
Body composition, bone mineral density (BMD), and body balance are important factors that threaten postural control. They act as vital elements in the vicious circle that leads to fracture occurrence in elderly population, particularly postmenopausal women.
Read the detailed description
- The purpose of the current study was to evaluate the relationships among body mass index (BMI), body balance, and BMD (g/cm²) in postmenopausal women to be able to identify risk factors for fractures.
- Forty-eight postmenopausal women participated in this study. Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.
The positive correlation between body balance and BMD in the current study can be explained that balance is controlled by sensory input, central processing, and neuromuscular responses. The sensory components consist of the vestibular, visual, and proprioceptive systems. An effective motor response requires an intact neuromuscular system and sufficient muscle strength to return the COG within the BOS when balance is disturbed. Postural balance in individuals with osteoporosis is significantly worse than in healthy individuals. Moreover, it was determined that balance scores in individuals with osteoporosis were 11% worse than scores of healthy individuals. Furthermore, exaggerated thoracic kyphotic curve is not only a disfiguring effect of osteoporosis but may also play a significant role in gait disorder, instability, and risk of falls.
In addition, back pain has a harmful impact on both balance and functional mobility in women with osteoporosis. Individuals with back pain may reduce their level of physical activity and, as a result, become weak in muscles required for balance and functional mobility. Impairment of the musculoskeletal and/or the neuromuscular system may negatively affect both balance and functional mobility.
In the same context, it was proved that women with decreased BMD and increased thoracic kyphosis presented greater body sway in the anterior/posterior direction on the force platform indicating more displacement of foot center of pressure (COP). They also confirmed that postmenopausal women with low BMD and increased thoracic kyphosis depend more on the hip strategy to maintain their postural control. This in turn probably causes more displacement of foot COP, thus causing greater body sway in all directions in comparison with the ankle strategy. it was also showed that women with loss of bone mass and increased thoracic kyphosis presented less foot COP displacement in the AP direction compared with the control group (with normal bone mass and normal thoracic curve.
The current study results also revealed that BMI was negatively correlated with both BMD and body balance in postmenopausal women. This can be illustrated that obese elderly women are often afraid of falls and sustaining fractures, so they prefer immobility and minimize their physical activity as much as possible. Because bone is formed when needed and resorbed when not needed as known as Wolff's law, BMD decreases and osteopenia/osteoporosis develops. Low BMD affect bone health as it leads to fragile weak bone and this in turn disturbs postural control and body balance. Additionally, obese women fail to control their center of gravity (COG) within base of support (BOS) disturbing their postural control and body balance, increasing risk of falls and making them more liable to fractures.
- Conditions
- Osteoporosis, Fall Patients, Postmenopausal Disorder
- Being tested
- Diagnostic test
- Keywords
- Body mass index,, Bone density, Balance, Postmenopause
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic test
Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between BMI and body balance
correlation analysis between BMI and body balance
Measured: 7 months
correlation between BMI and BMD
correlation analysis between BMI and BMD
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280693
- Sponsor's protocol ID
- P.T.REC/012/00731
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu-Ambrose T, Eng J, Khan K., Carter ND, McKay HA. Older women with osteoporosis have increased postural sway and weaker quadriceps strength than counterparts with normal bone mass: overlooked determinants of fracture risk? J Gerontol A Biol Sci Med Sci. 2003. 58 (9): 862-6. Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the timed up and go test. Phys Ther. 2000. 80(9): 896-903. Sinaki M, Brey RH, Hughes CA, Larson DR, Kaufman KR. Balance disorder and increased risk of falls in osteoporosis and kyphosis: significance of kyphotic posture and muscle strength. Osteoporos Int. 2005.16 (8):1004-10. Liu-Ambrose T, Eng JJ, Khan KM, Mallinson A, Carter ND, McKay HA. The influence of back pain on balance and functional mobility in 65 to 75 year old women with osteoporosis. Osteoporosis Int. 2002. 13 (11): 868-73. Lynn SG, Sinaki M, Westerlind KC. Balance characteristics of person with osteoporosis. Arch Phys Med Rehabil. 1997. 78 (3): 273-6. Frost HD. Wolff's law and bone's structural adaptations to mechanical usage: an overview for clinicians. The angle Orthod. 1994. 64 (3): 175-80. Taes YE, Lapauw B, Vanbillemont G, Bogaert V, De Bac¬quer D, Zmierczak H, et al. Fat mass is negatively associat¬ed with cortical bone size in young healthy male siblings. J Clin Endocrinol Metab. 2009; 94 (7): 2325-31.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Among Body Mass Index, Body Balance and Bone Mineral Density
- ClinicalTrials.gov ID
- NCT03280693
- Acronym / sponsor ID
- P.T.REC/012/00731
- Conditions
- Osteoporosis, Fall Patients, Postmenopausal Disorder
- Keywords
- Body mass index,, Bone density, Balance, Postmenopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Sep 2017 (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.
Body composition, bone mineral density (BMD), and body balance are important factors that threaten postural control. They act as vital elements in the vicious circle that leads to fracture occurrence in elderly population, particularly postmenopausal women.
Detailed description
- The purpose of the current study was to evaluate the relationships among body mass index (BMI), body balance, and BMD (g/cm²) in postmenopausal women to be able to identify risk factors for fractures.
- Forty-eight postmenopausal women participated in this study. Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.
The positive correlation between body balance and BMD in the current study can be explained that balance is controlled by sensory input, central processing, and neuromuscular responses. The sensory components consist of the vestibular, visual, and proprioceptive systems. An effective motor response requires an intact neuromuscular system and sufficient muscle strength to return the COG within the BOS when balance is disturbed. Postural balance in individuals with osteoporosis is significantly worse than in healthy individuals. Moreover, it was determined that balance scores in individuals with osteoporosis were 11% worse than scores of healthy individuals. Furthermore, exaggerated thoracic kyphotic curve is not only a disfiguring effect of osteoporosis but may also play a significant role in gait disorder, instability, and risk of falls.
In addition, back pain has a harmful impact on both balance and functional mobility in women with osteoporosis. Individuals with back pain may reduce their level of physical activity and, as a result, become weak in muscles required for balance and functional mobility. Impairment of the musculoskeletal and/or the neuromuscular system may negatively affect both balance and functional mobility.
In the same context, it was proved that women with decreased BMD and increased thoracic kyphosis presented greater body sway in the anterior/posterior direction on the force platform indicating more displacement of foot center of pressure (COP). They also confirmed that postmenopausal women with low BMD and increased thoracic kyphosis depend more on the hip strategy to maintain their postural control. This in turn probably causes more displacement of foot COP, thus causing greater body sway in all directions in comparison with the ankle strategy. it was also showed that women with loss of bone mass and increased thoracic kyphosis presented less foot COP displacement in the AP direction compared with the control group (with normal bone mass and normal thoracic curve.
The current study results also revealed that BMI was negatively correlated with both BMD and body balance in postmenopausal women. This can be illustrated that obese elderly women are often afraid of falls and sustaining fractures, so they prefer immobility and minimize their physical activity as much as possible. Because bone is formed when needed and resorbed when not needed as known as Wolff's law, BMD decreases and osteopenia/osteoporosis develops. Low BMD affect bone health as it leads to fragile weak bone and this in turn disturbs postural control and body balance. Additionally, obese women fail to control their center of gravity (COG) within base of support (BOS) disturbing their postural control and body balance, increasing risk of falls and making them more liable to fractures.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Forty-eight postmenopausal women participated in this study. Their mean values of age, body mass, height, and BMI were 53.5 ± 2.75 y, 89.08 ± 12.3 Kg, 159.67.8 ± 2.54 cm, and 34.89 ± 4.89 Kg/m², respectively. Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.
Key inclusion criteria (1 listed)
- postmenopausal women with ages range from 50 to 60 years
Key exclusion criteria (3 listed)
- participation in sports
- vertebrobasillar insufficiency
- poor diet
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 |
|---|---|---|
| Diagnostic testBody balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan. | Diagnostic test | – |
Primary outcome
correlation between BMI and body balance
Time frame: 7 months
correlation analysis between BMI and body balance
correlation between BMI and BMD
Time frame: 7 months
correlation analysis between BMI and BMD
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 12 Sep 2017.
- BackgroundLiu-Ambrose T, Eng J, Khan K., Carter ND, McKay HA. Older women with osteoporosis have increased postural sway and weaker quadriceps strength than counterparts with normal bone mass: overlooked determinants of fracture risk? J Gerontol A Biol Sci Med Sci. 2003. 58 (9): 862-6. Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the timed up and go test. Phys Ther. 2000. 80(9): 896-903. Sinaki M, Brey RH, Hughes CA, Larson DR, Kaufman KR. Balance disorder and increased risk of falls in osteoporosis and kyphosis: significance of kyphotic posture and muscle strength. Osteoporos Int. 2005.16 (8):1004-10. Liu-Ambrose T, Eng JJ, Khan KM, Mallinson A, Carter ND, McKay HA. The influence of back pain on balance and functional mobility in 65 to 75 year old women with osteoporosis. Osteoporosis Int. 2002. 13 (11): 868-73. Lynn SG, Sinaki M, Westerlind KC. Balance characteristics of person with osteoporosis. Arch Phys Med Rehabil. 1997. 78 (3): 273-6. Frost HD. Wolff's law and bone's structural adaptations to mechanical usage: an overview for clinicians. The angle Orthod. 1994. 64 (3): 175-80. Taes YE, Lapauw B, Vanbillemont G, Bogaert V, De Bac¬quer D, Zmierczak H, et al. Fat mass is negatively associat¬ed with cortical bone size in young healthy male siblings. J Clin Endocrinol Metab. 2009; 94 (7): 2325-31.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fall Patients, run by Cairo University.
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 3 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
correlation between BMI and body balance (time frame: 7 months). 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 NCT03280693, which also lists 1 linked publication.
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 12 Sep 2017.