OsteopeniaNCT03195517

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

A study testing Physical exercise in people with Osteopenia and Bone Turnover Markers, run by University Of Perugia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 52 to 70 years, women only
Conditions the study is for: Osteopenia, Bone Turnover Markers, Quality of Life
What is being tested?: Physical exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: No sites listed yet
Study dates: May 2015to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 52 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

About this study

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.

Read the 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.

Conditions: Osteopenia, Bone Turnover Markers, Quality of Life
Being tested: Physical exercise
Keywords: Osteopenia, Physical activity, Bone turnover markers, Osteoprogenitor cells, Quality of life
Medical subject headings: Bone Diseases, Metabolic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical exerciseOther

Study groups in NCT03195517
Study group	Role	What they receive
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. Receives: Other: Physical exercise
No additional physical exercise	No intervention	Usual recommendations for prevention of fractures in adults and elderly.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Week 4 - Week 12
Serum Sclerotin Levels
Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
Measured: Baseline - W4
Sclerostin
Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
Measured: 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
Measured: 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.
Measured: 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 +).
Measured: 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 +).
Measured: Week 4 - Week 12

Secondary outcomes (2)

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.
Measured: Baseline - Week 4
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.
Measured: Week 4 - Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Mar 2016

First posted22 Jun 2017
Study startMay 2015
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for OsteopeniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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.
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03195517
Sponsor's protocol ID: OPCuriamo-1
Status last verified: Sep 2018
First submitted: 15 Jun 2017
Last updated: 11 Feb 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. doi: 10.1007/BF03026318.
PubMed 15984409
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.
PubMed 27244129
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.
PubMed 18981037
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.
PubMed 18089564
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.
PubMed 19717503
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.
PubMed 19484167
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.
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.
PubMed 18949504
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.
PubMed 30809725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Osteopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03195517
Acronym / sponsor ID: OPCuriamo-1
Conditions: Osteopenia, Bone Turnover Markers, Quality of Life
Keywords: Osteopenia, Physical activity, Bone turnover markers, Osteoprogenitor cells, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: University Of PerugiaUniversity, hospital or other
Study start: May 2015
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 22 Jun 2017 (actual)
Results: Posted 11 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Physical Exercise	Experimental	Other: Physical exerciseThe 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.
No additional physical exercise	No intervention	–Usual recommendations for prevention of fractures in adults and elderly.

Who may qualify

Ages: 52 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical exercise	Other	Physical Exercise

Primary outcome

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

2 secondary outcomes

Variation in Health-related Quality of Life (QoL)
Time frame: Baseline - Week 4
Variation in Health-related Quality of Life (QoL).
Time frame: Week 4 - Week 12

Results and safety

Results posted to the registry on 11 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control/Exercise Training	33	33

Primary outcome: Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)

Time frame: Baseline - Week 4. Mean (Standard Deviation). Unit: mcg/L

Measure	No Additional Physical Exercise n = 33
P1NP, Baseline	58.34 (9.24)
P1NP, W4	57.91 (8.49)

No Additional Physical Exercise: p = 0.05, t-test, 1 sided

Population analysed: 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)

Primary outcome: Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).

Time frame: Week 4 - Week 12. Mean (Standard Deviation). Unit: mcg/L

Measure	Physical Exercise n = 33
P1NP, W4	57.91 (8.49)
P1NP, W12	64.87 (12.67)

Physical Exercise: p = 0.05, t-test, 1 sided

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

Primary outcome: Serum Sclerotin Levels

Time frame: Baseline - W4. Mean (Standard Deviation). Unit: pmol/L

Measure	No Additional Physical Exercise n = 33
Sclerostin, Baseline	36.76 (9.68)
Sclerostin, W4	37.30 (9.24)

No Additional Physical Exercise: p = 0.05, t-test, 1 sided

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

Primary outcome: Sclerostin

Time frame: Week 4 - Week 12. Mean (Standard Deviation). Unit: pmol/L

Measure	Physical Exercise n = 33
Sclerostin, W4	37.30 (9.24)
Sclerostin, W12	33.96 (7.29)

Physical Exercise: p = 0.05, t-test, 1 sided

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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control/Exercise Training	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15984409Turner CH, Robling AG. Mechanisms by which exercise improves bone strength. J Bone Miner Metab. 2005;23 Suppl:16-22. doi: 10.1007/BF03026318.
Background: PubMed 27244129Pasqualini 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.
Background: PubMed 18981037Martyn-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.
Background: PubMed 18089564Robling 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.
Background: PubMed 19717503Li 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.
Background: PubMed 19484167Pirro 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.
BackgroundLips 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: PubMed 18949504Adami 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.
Derived from this study: PubMed 30809725Pasqualini 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lombardini principal investigator

University Of Perugia

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise in people with Osteopenia and Bone Turnover Markers, run by University Of Perugia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) (time frame: Baseline - Week 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03195517, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.