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

NCT03195517 | Completed Results

• 1 other identifier: OPCuriamo-1
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteopenia; Bone Turnover Markers; Quality of Life

Keywords

Osteopenia; Physical activity; Bone turnover markers; Osteoprogenitor cells; Quality of life

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Variation in Health-related Quality of Life (QoL)

  Baseline - Week 4

• Variation in Health-related Quality of Life (QoL).

  Week 4 - Week 12

Study Arms (2)

Physical Exercise

EXPERIMENTAL

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 additional physical exercise

NO INTERVENTION

Usual recommendations for prevention of fractures in adults and elderly.

Interventions

Physical exercise OTHER

Physical Exercise

Eligibility Criteria

• Age: 52 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Of Perugia: lead

Related Publications (9)

• Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. doi: 10.1007/BF03026318.

  PMID: 15984409 BACKGROUND

• 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.

  PMID: 27244129 BACKGROUND

• 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.

  PMID: 18981037 BACKGROUND

• 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. doi: 10.1074/jbc.M705092200. Epub 2007 Dec 17.

  PMID: 18089564 BACKGROUND

• 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.

  PMID: 19717503 BACKGROUND

• 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.

  PMID: 19484167 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18949504 BACKGROUND

• Pasqualini L, Ministrini S, Lombardini R, Bagaglia F, Paltriccia R, Pippi R, Collebrusco L, Reginato E, Sbroma Tomaro E, Marini E, D'Abbondanza M, Scarponi AM, De Feo P, Pirro M. Effects of a 3-month weight-bearing and resistance exercise training on circulating osteogenic cells and bone formation markers in postmenopausal women with low bone mass. Osteoporos Int. 2019 Apr;30(4):797-806. doi: 10.1007/s00198-019-04908-9. Epub 2019 Feb 26.

  PMID: 30809725 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and 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.

Results Point of Contact

• Title: Dr. Rita Lombardini
• Organization: University of Perugia - Italy

rita.lombardini@unipg.it

+39 075 578 4027

Study Officials

• Lombardini

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 22, 2017
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2018-09