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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Osteopenia, Bone Turnover Markers, Quality of Life

Intervention / Treatment
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* Other: Physical exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 52 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Exercise<br>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<br> <br> |
| No Intervention: No additional physical exercise<br>Usual recommendations for prevention of fractures in adults and elderly. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopenia, Physical activity, Bone turnover markers, Osteoprogenitor cells, Quality of life