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Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.

Primary Purpose

Osteopenia, Bone Turnover Markers, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring Osteopenia, Physical activity, Bone turnover markers, Osteoprogenitor cells, Quality of life

Eligibility Criteria

52 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • postmenopausal
  • bone mineral density T-score less than -1 but more than -2.5 in the total hip or lumbar spine (L1-L4) by dual energy x-ray absorptiometry
  • be able to attend an exercise program 2 times per week over the 3-month period
  • stated availability throughout the entire study period

Exclusion Criteria:

  • secondary causes of bone loss such as osteomalacia, glucocorticoid medication
  • co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
  • physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
  • a past vertebral fracture
  • history of chronic diseases, such as renal, hepatic, cardiac, and rheumatic diseases
  • current or prior use of drugs that could interfere with bone mass (i.e. glucocorticoids, antiresorptive drugs and hormonal replacement therapy)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Physical Exercise

    No additional physical exercise

    Arm Description

    The exercise program was performed at C.U.R.I.A.Mo. Institute of "Università degli Studi di Perugia". Twenty-four exercise sessions were provided, carried out twice a week for three months. Each session was supervised by two graduated trainers and two medical doctors with a maximum attendance of 5 patient/group. Each session lasted 45 minutes divided into 15 minutes of aerobic activity and 30 minutes of weight-bearing and resistance activities. This latter section was specifically projected for adults and older adults with increased risk of fractures and was intended to improve muscle strength and flexibility, balance and, as a result, to prevent the risk of falls.

    Usual recommendations for prevention of fractures in adults and elderly.

    Outcomes

    Primary Outcome Measures

    Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)
    P1NP is the most reliable serum marker of bone formation commercially available at the moment
    Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).
    P1NP is the most reliable serum marker of bone formation, commercially available at the moment.
    Serum Sclerotin Levels
    Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
    Sclerostin
    Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
    Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)
    Serum carboxy-terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation
    Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)
    Serum carboxy terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation.
    Variation in Circulating Osteoprogenitor Cells (OPCs)
    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
    Variation in Circulating Osteoprogenitor Cells (OPCs).
    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).

    Secondary Outcome Measures

    Variation in Health-related Quality of Life (QoL)
    Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.
    Variation in Health-related Quality of Life (QoL).
    Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.

    Full Information

    First Posted
    June 15, 2017
    Last Updated
    September 18, 2018
    Sponsor
    University Of Perugia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03195517
    Brief Title
    Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.
    Official Title
    Effects of a 3-month Weight-bearing and Resistance Exercise Training on Circulating Osteoprogenitor Cells and Bone Formation Markers in Postmenopausal Women With Low Bone Mass.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Of Perugia

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of our research was to define both in vivo and in vitro whether and to what extent an high-impact exercise program would affect bone cell turnover and improve the QoL in osteopenic postmenopausal women.
    Detailed Description
    Subjects were selected among those attending the "Bone and Mineral Metabolism Disorders" Clinic of Perugia University, Italy, since May 2nd 2015 and January 31st 2016. A total of 33 post-menopausal women volunteered to participate in the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteopenia, Bone Turnover Markers, Quality of Life
    Keywords
    Osteopenia, Physical activity, Bone turnover markers, Osteoprogenitor cells, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    This was an interventional, single group assignment study in which the subjects were first assigned to the control group and, after 1-month interval with no physical training, were shifted into the 3-months exercise intervention group. Thus, the subjects acted as their own control at the end of the study.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Exercise
    Arm Type
    Experimental
    Arm Description
    The exercise program was performed at C.U.R.I.A.Mo. Institute of "Università degli Studi di Perugia". Twenty-four exercise sessions were provided, carried out twice a week for three months. Each session was supervised by two graduated trainers and two medical doctors with a maximum attendance of 5 patient/group. Each session lasted 45 minutes divided into 15 minutes of aerobic activity and 30 minutes of weight-bearing and resistance activities. This latter section was specifically projected for adults and older adults with increased risk of fractures and was intended to improve muscle strength and flexibility, balance and, as a result, to prevent the risk of falls.
    Arm Title
    No additional physical exercise
    Arm Type
    No Intervention
    Arm Description
    Usual recommendations for prevention of fractures in adults and elderly.
    Intervention Type
    Other
    Intervention Name(s)
    Physical exercise
    Primary Outcome Measure Information:
    Title
    Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)
    Description
    P1NP is the most reliable serum marker of bone formation commercially available at the moment
    Time Frame
    Baseline - Week 4
    Title
    Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).
    Description
    P1NP is the most reliable serum marker of bone formation, commercially available at the moment.
    Time Frame
    Week 4 - Week 12
    Title
    Serum Sclerotin Levels
    Description
    Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
    Time Frame
    Baseline - W4
    Title
    Sclerostin
    Description
    Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
    Time Frame
    Week 4 - Week 12
    Title
    Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)
    Description
    Serum carboxy-terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation
    Time Frame
    Baseline - Week 4
    Title
    Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)
    Description
    Serum carboxy terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation.
    Time Frame
    Week 4 - Week 12
    Title
    Variation in Circulating Osteoprogenitor Cells (OPCs)
    Description
    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
    Time Frame
    Baseline - Week 4
    Title
    Variation in Circulating Osteoprogenitor Cells (OPCs).
    Description
    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).
    Time Frame
    Week 4 - Week 12
    Secondary Outcome Measure Information:
    Title
    Variation in Health-related Quality of Life (QoL)
    Description
    Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.
    Time Frame
    Baseline - Week 4
    Title
    Variation in Health-related Quality of Life (QoL).
    Description
    Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.
    Time Frame
    Week 4 - Week 12

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    52 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: postmenopausal bone mineral density T-score less than -1 but more than -2.5 in the total hip or lumbar spine (L1-L4) by dual energy x-ray absorptiometry be able to attend an exercise program 2 times per week over the 3-month period stated availability throughout the entire study period Exclusion Criteria: secondary causes of bone loss such as osteomalacia, glucocorticoid medication co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise a past vertebral fracture history of chronic diseases, such as renal, hepatic, cardiac, and rheumatic diseases current or prior use of drugs that could interfere with bone mass (i.e. glucocorticoids, antiresorptive drugs and hormonal replacement therapy)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lombardini
    Organizational Affiliation
    University Of Perugia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15984409
    Citation
    Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. doi: 10.1007/BF03026318.
    Results Reference
    background
    PubMed Identifier
    27244129
    Citation
    Pasqualini L, Leli C, Ministrini S, Schillaci G, Zappavigna RM, Lombardini R, Scarponi AM, Mannarino E. Relationships between global physical activity and bone mineral density in a group of male and female students. J Sports Med Phys Fitness. 2017 Mar;57(3):238-243. doi: 10.23736/S0022-4707.16.06054-0. Epub 2016 May 31.
    Results Reference
    background
    PubMed Identifier
    18981037
    Citation
    Martyn-St James M, Carroll S. A meta-analysis of impact exercise on postmenopausal bone loss: the case for mixed loading exercise programmes. Br J Sports Med. 2009 Dec;43(12):898-908. doi: 10.1136/bjsm.2008.052704. Epub 2008 Nov 3.
    Results Reference
    background
    PubMed Identifier
    18089564
    Citation
    Robling AG, Niziolek PJ, Baldridge LA, Condon KW, Allen MR, Alam I, Mantila SM, Gluhak-Heinrich J, Bellido TM, Harris SE, Turner CH. Mechanical stimulation of bone in vivo reduces osteocyte expression of Sost/sclerostin. J Biol Chem. 2008 Feb 29;283(9):5866-75. doi: 10.1074/jbc.M705092200. Epub 2007 Dec 17.
    Results Reference
    background
    PubMed Identifier
    19717503
    Citation
    Li WC, Chen YC, Yang RS, Tsauo JY. Effects of exercise programmes on quality of life in osteoporotic and osteopenic postmenopausal women: a systematic review and meta-analysis. Clin Rehabil. 2009 Oct;23(10):888-96. doi: 10.1177/0269215509339002. Epub 2009 Aug 28.
    Results Reference
    background
    PubMed Identifier
    19484167
    Citation
    Pirro M, Leli C, Fabbriciani G, Manfredelli MR, Callarelli L, Bagaglia F, Scarponi AM, Mannarino E. Association between circulating osteoprogenitor cell numbers and bone mineral density in postmenopausal osteoporosis. Osteoporos Int. 2010 Feb;21(2):297-306. doi: 10.1007/s00198-009-0968-0. Epub 2009 May 30.
    Results Reference
    background
    Citation
    Lips P, Leplege A (2000). Development and validation of quality of life questionnaire for patients with vertebral fractures: Qualeffo-41. Quality of Life Research 9(6a):763-766.
    Results Reference
    background
    PubMed Identifier
    18949504
    Citation
    Adami S, Gatti D, Viapiana O, Fiore CE, Nuti R, Luisetto G, Ponte M, Rossini M; BONTURNO Study Group. Physical activity and bone turnover markers: a cross-sectional and a longitudinal study. Calcif Tissue Int. 2008 Dec;83(6):388-92. doi: 10.1007/s00223-008-9184-8. Epub 2008 Oct 24.
    Results Reference
    background
    PubMed Identifier
    30809725
    Citation
    Pasqualini L, Ministrini S, Lombardini R, Bagaglia F, Paltriccia R, Pippi R, Collebrusco L, Reginato E, Sbroma Tomaro E, Marini E, D'Abbondanza M, Scarponi AM, De Feo P, Pirro M. Effects of a 3-month weight-bearing and resistance exercise training on circulating osteogenic cells and bone formation markers in postmenopausal women with low bone mass. Osteoporos Int. 2019 Apr;30(4):797-806. doi: 10.1007/s00198-019-04908-9. Epub 2019 Feb 26.
    Results Reference
    derived

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    Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.

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