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

Quality of Life Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195517
• Other study ID #: OPCuriamo-1
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2018
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 52 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Bone Turnover Markers
• Osteopenia
• Quality of Life

Intervention

Other:
• Physical exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Serum Sclerotin Levels	Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.	Baseline - W4
Primary	Sclerostin	Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.	Week 4 - Week 12
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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