Clinical trial NCT03195517: Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Bone Turnover Markers
Quality of Life
Keywords: Osteopenia
Physical activity
Bone turnover markers
Osteoprogenitor cells
Quality of life
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 33
Sex: FEMALE
Minimum age (years): 52
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)
timeFrame: Baseline - Week 4
measure: Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).
timeFrame: Week 4 - Week 12
measure: Serum Sclerotin Levels
timeFrame: Baseline - W4
measure: Sclerostin
timeFrame: Week 4 - Week 12
measure: Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)
timeFrame: Baseline - Week 4
measure: Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)
timeFrame: Week 4 - Week 12
measure: Variation in Circulating Osteoprogenitor Cells (OPCs)
timeFrame: Baseline - Week 4
measure: Variation in Circulating Osteoprogenitor Cells (OPCs).
timeFrame: Week 4 - Week 12
Secondary outcomes:
measure: Variation in Health-related Quality of Life (QoL)
timeFrame: Baseline - Week 4
measure: Variation in Health-related Quality of Life (QoL).
timeFrame: Week 4 - Week 12
Other outcomes:
Locations:
Study officials:
affiliation: University Of Perugia
name: Lombardini
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. doi: 10.1007/BF03026318.
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.
citation: 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.
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. doi: 10.1074/jbc.M705092200. Epub 2007 Dec 17.
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.
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.
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.
citation: 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.
citation: 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.