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

• Sponsor: University Of Perugia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03195517
• Collaborator: (none)
• Enrollment: 33
• Arms: 2
• Duration (Months): 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia; Bone Turnover Markers; Quality of Life	Other: Physical exercise	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

3. Serum Sclerotin Levels [Baseline - W4]

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

4. Sclerostin [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) [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) [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) [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). [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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 52 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Of Perugia

Investigators

• Principal Investigator: Lombardini, University of Perugia, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.
• 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. Review.
• 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.
• 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.
• 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. Epub 2007 Dec 17.
• Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. Review.

• Responsible Party: Rita Lombardini, Principal Investigator, University Of Perugia
• ClinicalTrials.gov Identifier: NCT03195517
• Other Study ID Numbers: OPCuriamo-1
• First Posted: Jun 22, 2017
• Last Update Posted: Feb 11, 2019
• Last Verified: Sep 1, 2018

• Keywords provided by Rita Lombardini, Principal Investigator, University Of Perugia: Osteopenia; Physical activity; Bone turnover markers; Osteoprogenitor cells; Quality of life
• Additional relevant MeSH terms: Bone Diseases, Metabolic

Study Results

Participant Flow

Arm/Group Title	Control/Exercise Training
Arm/Group Description	At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in. All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training.
Period Title: Overall Study
STARTED	33
COMPLETED	33
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Control/Exercise Training
Arm/Group Description	33 osteopenic postmenopausal women were included in the study. Bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment, after 1 month run-in and after 3 months of high-impact exercise training.
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	21 63.6%
>=65 years	12 36.4%
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (5.8)
Sex/Gender, Customized (Count of Participants)
Count of Participants [Participants]	33 100%
Sex: Female, Male (Count of Participants)
Female	33 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	33 100%
Unknown or Not Reported	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	33 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	33 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
Italy	33 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Post-menopausal women with low bone mass at dual energy X-ray absorptiometry (DEXA) measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)

Arm/Group Title	No Additional Physical Exercise
Arm/Group Description	Usual recommendations for prevention of fractures in adults and elderly.
Measure Participants	33
P1NP, Baseline	58.34 (9.24)
P1NP, W4	57.91 (8.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)

Arm/Group Title	Physical Exercise
Arm/Group 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. Physical exercise
Measure Participants	33
P1NP, W4	57.91 (8.49)
P1NP, W12	64.87 (12.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)

Arm/Group Title	No Additional Physical Exercise
Arm/Group Description	Usual recommendations for prevention of fractures in adults and elderly.
Measure Participants	33
Sclerostin, Baseline	36.76 (9.68)
Sclerostin, W4	37.30 (9.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

4. Primary Outcome

Title	Sclerostin
Description	Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
Time Frame	Week 4 - Week 12

Outcome Measure Data

Analysis Population Description

Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS).

Arm/Group Title	Physical Exercise
Arm/Group 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. Physical exercise
Measure Participants	33
Sclerostin, W4	37.30 (9.24)
Sclerostin, W12	33.96 (7.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control/Exercise Training
Arm/Group Description	Usual care and no additional physical exercise
Measure Participants	33
sCTX baseline	0.52 (0.13)
sCTX, W4	0.53 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control/Exercise Training
Arm/Group Description	The exercise program was performed at C.U.R.I.A.Mo. Healthy Lifestyle Institute of Perugia University. The program provided 24 exercise sessions supervised by 2 physical education instructors and 2 medical researchers with a maximum attendance of 5 patient/group and carried out twice a week for three months. Each session lasted approximately 45 minutes divided into 15 minutes of cardiovascular activity performed using various ergometers and 30 minutes of weight-bearing endurance activities, resistance training and other exercise to develop balance and prevent falls, organized according to circuit training methodology. The great part of the exercise included in the program aim to provide variably strains (compression, bending, twisting) distributed across an higher surface of the femoral neck, to produce a maximal osteogenic response.
Measure Participants	33
sCTX, W4	0.53 (0.14)
sCTX, W12	0.56 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control/Exercise Training
Arm/Group Description	Usual care and no additional physical exercise
Measure Participants	33
OCN+/CD34+ baseline	1304.94 (782.79)
OCN+/CD34+, W4	1393.92 (687.76)
OCN+/AP+ baseline	4485.21 (1690.12)
OCN+/AP+, W4	4512.60 (1658.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control/Exercise Training
Arm/Group Description	The exercise program was performed at C.U.R.I.A.Mo. Healthy Lifestyle Institute of Perugia University. The program provided 24 exercise sessions supervised by 2 physical education instructors and 2 medical researchers with a maximum attendance of 5 patient/group and carried out twice a week for three months. Each session lasted approximately 45 minutes divided into 15 minutes of cardiovascular activity performed using various ergometers and 30 minutes of weight-bearing endurance activities, resistance training and other exercise to develop balance and prevent falls, organized according to circuit training methodology. The great part of the exercise included in the program aim to provide variably strains (compression, bending, twisting) distributed across an higher surface of the femoral neck, to produce a maximal osteogenic response.
Measure Participants	33
OCN+/CD34+, W4	1393.92 (687.76)
OCN+/CD34+, W12	2311.82 (1356.20)
OCN+/AP+, W4	4512.60 (1658.76)
OCN+/AP+, W12	5062.00 (1975.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control/Exercise Training
Arm/Group Description	At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in. All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training.
Measure Participants	33
Pain, Baseline	22.59 (17.67)
Pain, W4	21.97 (19.84)
Physical function, Baseline	9.89 (6.89)
Physica function, W4	9.75 (6.52)
Social function, Baseline	24.38 (11.75)
Social function, W4	23.77 (12.21)
General health perception, Baseline	43.23 (14.73)
General health perception, W4	45.29 (14.12)
Mental function, Baseline	30.20 (10.89)
Mental function, W4	30.09 (9.02)
Total score, Baseline	20.51 (7.06)
Total score, W4	20.70 (7.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control/Exercise Training
Arm/Group Description	At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in. All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training.
Measure Participants	33
Pain, W4	21.97 (19.84)
Physical function, W4	9.75 (6.52)
Social function, W4	23.77 (12.21)
General health perception, W4	45.29 (14.12)
Mental function, W4	30.09 (9.02)
Total score, W4	20.70 (7.11)
Pain, W12	13.36 (12.45)
Physical function, W12	8.13 (6.22)
Social function, W12	22.10 (12.88)
General health perception, W12	41.66 (14.47)
Mental function, W12	28.55 (10.25)
Total score, W12	18.55 (7.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Additional Physical Exercise
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Arm/Group Title	Control/Exercise Training
Arm/Group Description	At the start of the study, all participants were assigned to 1-month non-exercise control group. Measurements of bone formation markers, circulating osteoprogenitor cells and health-related quality of life were evaluated at the time of enrollment and after 1 month run-in. All study participants, assigned to 1-month non-exercise control group, were shifted into the exercise intervention group. Measurements of bone formation markers, circulating osteoprogenitor cells, physical fitness and health-related quality of life were evaluated after 3-months of high-impact exercise training.
All Cause Mortality
	Control/Exercise Training
	Affected / at Risk (%)	# Events
Total	0/33 (0%)
Serious Adverse Events
	Control/Exercise Training
	Affected / at Risk (%)	# Events
Total	0/33 (0%)
Other (Not Including Serious) Adverse Events
	Control/Exercise Training
	Affected / at Risk (%)	# Events
Total	0/33 (0%)

Limitations/Caveats

Short duration of the observation (12 weeks). Small number of the sample. We did not provide any confirmation of the effects of the exercise program in terms of bone mineral density (BMD) or fracture risk.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.