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

September 18, 2018 updated by: Rita Lombardini, University Of Perugia

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

52 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Exercise

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.
Other: Physical exercise
No Intervention: No additional physical exercise
Usual recommendations for prevention of fractures in adults and elderly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline - Week 4
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.
Week 4 - Week 12
Serum Sclerotin Levels
Time Frame: Baseline - W4
Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
Baseline - W4
Sclerostin
Time Frame: Week 4 - Week 12
Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
Week 4 - Week 12
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
Baseline - Week 4
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.
Week 4 - Week 12
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 +).
Baseline - Week 4
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 +).
Week 4 - Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline - Week 4
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.
Week 4 - Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Investigators

  • Principal Investigator: Lombardini, University of Perugia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPCuriamo-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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