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

Not Applicable

Completed

• Conditions: Osteopenia; Quality of Life; Bone Turnover Markers
• Interventions: Other: Physical exercise

• Registration Number: NCT03195517
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-22
• Results First Submitted: 2017-10-31
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-18
• Last Update Submitted: 2018-09-18
• Results First Posted: 2019-02-11
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Physical Exercise	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.

Primary Outcome Measures

Name	Time	Method
Serum Sclerotin Levels	Baseline - W4	Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
Sclerostin	Week 4 - Week 12	Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)	Baseline - Week 4	P1NP is the most reliable serum marker of bone formation commercially available at the moment
Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)	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.
Variation in Circulating Osteoprogenitor Cells (OPCs).	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 +).
Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).	Week 4 - Week 12	P1NP is the most reliable serum marker of bone formation, commercially available at the moment.
Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)	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
Variation in Circulating Osteoprogenitor Cells (OPCs)	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 +).

Secondary Outcome Measures

Name	Time	Method
Variation in Health-related Quality of Life (QoL)	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.
Variation in Health-related Quality of Life (QoL).	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.