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Completed

NCT Number: NCT03195517

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

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.

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Key information

Conditions

Osteopenia Behavior Bone Diseases Bone Diseases, Metabolic Bone Turnover Markers Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Quality of Life

Age range

52 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physical exercise

Other

Primary outcomes

  1. Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)

    Time frame: Baseline - Week 4

    P1NP is the most reliable serum marker of bone formation commercially available at the moment

  2. Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).

    Time frame: Week 4 - Week 12

    P1NP is the most reliable serum marker of bone formation, commercially available at the moment.

  3. Serum Sclerotin Levels

    Time frame: Baseline - W4

    Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.

  4. Sclerostin

    Time frame: Week 4 - Week 12

    Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.

  5. Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)

    Time frame: Baseline - Week 4

    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

  6. Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)

    Time frame: Week 4 - Week 12

    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.

  7. Variation in Circulating Osteoprogenitor Cells (OPCs)

    Time frame: Baseline - Week 4

    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).

  8. Variation in Circulating Osteoprogenitor Cells (OPCs).

    Time frame: Week 4 - Week 12

    Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).

Secondary outcomes

  1. Variation in Health-related Quality of Life (QoL)

    Time frame: Baseline - Week 4

    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.

  2. Variation in Health-related Quality of Life (QoL).

    Time frame: Week 4 - Week 12

    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.

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2017
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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