<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03280693</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/00731</org_study_id>
    <nct_id>NCT03280693</nct_id>
  </id_info>
  <brief_title>Relationships Among Body Mass Index, Body Balance and Bone Mineral Density in Postmenopausal Women</brief_title>
  <official_title>Relationships Among Body Mass Index, Body Balance and Bone Mineral Density</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Body composition, bone mineral density (BMD), and body balance are important factors that&#xD;
      threaten postural control. They act as vital elements in the vicious circle that leads to&#xD;
      fracture occurrence in elderly population, particularly postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The purpose of the current study was to evaluate the relationships among body mass index&#xD;
           (BMI), body balance, and BMD (g/cm²) in postmenopausal women to be able to identify risk&#xD;
           factors for fractures.&#xD;
&#xD;
        -  Forty-eight postmenopausal women participated in this study. Body balance was assessed&#xD;
           using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual&#xD;
           energy X-ray absorptiometry (DEXA) scan.&#xD;
&#xD;
      The positive correlation between body balance and BMD in the current study can be explained&#xD;
      that balance is controlled by sensory input, central processing, and neuromuscular responses.&#xD;
      The sensory components consist of the vestibular, visual, and proprioceptive systems. An&#xD;
      effective motor response requires an intact neuromuscular system and sufficient muscle&#xD;
      strength to return the COG within the BOS when balance is disturbed. Postural balance in&#xD;
      individuals with osteoporosis is significantly worse than in healthy individuals. Moreover,&#xD;
      it was determined that balance scores in individuals with osteoporosis were 11% worse than&#xD;
      scores of healthy individuals. Furthermore, exaggerated thoracic kyphotic curve is not only a&#xD;
      disfiguring effect of osteoporosis but may also play a significant role in gait disorder,&#xD;
      instability, and risk of falls.&#xD;
&#xD;
      In addition, back pain has a harmful impact on both balance and functional mobility in women&#xD;
      with osteoporosis. Individuals with back pain may reduce their level of physical activity&#xD;
      and, as a result, become weak in muscles required for balance and functional mobility.&#xD;
      Impairment of the musculoskeletal and/or the neuromuscular system may negatively affect both&#xD;
      balance and functional mobility.&#xD;
&#xD;
      In the same context, it was proved that women with decreased BMD and increased thoracic&#xD;
      kyphosis presented greater body sway in the anterior/posterior direction on the force&#xD;
      platform indicating more displacement of foot center of pressure (COP). They also confirmed&#xD;
      that postmenopausal women with low BMD and increased thoracic kyphosis depend more on the hip&#xD;
      strategy to maintain their postural control. This in turn probably causes more displacement&#xD;
      of foot COP, thus causing greater body sway in all directions in comparison with the ankle&#xD;
      strategy. it was also showed that women with loss of bone mass and increased thoracic&#xD;
      kyphosis presented less foot COP displacement in the AP direction compared with the control&#xD;
      group (with normal bone mass and normal thoracic curve.&#xD;
&#xD;
      The current study results also revealed that BMI was negatively correlated with both BMD and&#xD;
      body balance in postmenopausal women. This can be illustrated that obese elderly women are&#xD;
      often afraid of falls and sustaining fractures, so they prefer immobility and minimize their&#xD;
      physical activity as much as possible. Because bone is formed when needed and resorbed when&#xD;
      not needed as known as Wolff's law, BMD decreases and osteopenia/osteoporosis develops. Low&#xD;
      BMD affect bone health as it leads to fragile weak bone and this in turn disturbs postural&#xD;
      control and body balance. Additionally, obese women fail to control their center of gravity&#xD;
      (COG) within base of support (BOS) disturbing their postural control and body balance,&#xD;
      increasing risk of falls and making them more liable to fractures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>correlation between BMI and body balance</measure>
    <time_frame>7 months</time_frame>
    <description>correlation analysis between BMI and body balance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>correlation between BMI and BMD</measure>
    <time_frame>7 months</time_frame>
    <description>correlation analysis between BMI and BMD</description>
  </primary_outcome>
  <enrollment type="Actual">48</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Fall Patients</condition>
  <condition>Postmenopausal Disorder</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic test</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Forty-eight postmenopausal women participated in this study. Their mean values of age, body&#xD;
        mass, height, and BMI were 53.5 ± 2.75 y, 89.08 ± 12.3 Kg, 159.67.8 ± 2.54 cm, and 34.89 ±&#xD;
        4.89 Kg/m², respectively. Body balance was assessed using Berg Balance Scale (BBS), while&#xD;
        BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postmenopausal women with ages range from 50 to 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation in sports&#xD;
&#xD;
          -  vertebrobasillar insufficiency&#xD;
&#xD;
          -  poor diet&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The study is based on investigating changes in the measured variables in postmenopausal women</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <reference>
    <citation>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.</citation>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Azza Mohammed</investigator_full_name>
    <investigator_title>Principal invstigator</investigator_title>
  </responsible_party>
  <keyword>Body mass index,</keyword>
  <keyword>Bone density</keyword>
  <keyword>Balance</keyword>
  <keyword>Postmenopause</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280693
org study id: P.T.REC/012/00731
nct id: NCT03280693
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
-  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.
observational model: Case-Only
time perspective: Retrospective
measure: correlation between BMI and body balance
time frame: 7 months
description: correlation analysis between BMI and body balance
measure: correlation between BMI and BMD
time frame: 7 months
description: correlation analysis between BMI and BMD
intervention type: Diagnostic Test
intervention name: Diagnostic test
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: The study is based on investigating changes in the measured variables in postmenopausal women
minimum age: 50 Years
maximum age: 60 Years
citation: 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.
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Azza Mohammed
investigator title: Principal invstigator
mesh term: Osteoporosis
sharing ipd: No