Bone Turnover Markers, Osteopenia, Quality of Life
Conditions
Keywords
Osteopenia, Physical activity, Bone turnover markers, Osteoprogenitor cells, Quality of life
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.
Interventions
OTHERPhysical exercise
Sponsors
University Of Perugia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
52 Years to 70 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 +). |
| 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. |
| 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 +). |
| 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 |
| 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. |
| Serum Sclerotin Levels | Baseline - W4 | Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism. |
| Sclerostin | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control/Exercise Training 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Control/Exercise Training |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Customized | 62.6 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment Italy | 33 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sex/Gender, Customized | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Sclerostin
Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.
Time frame: Week 4 - Week 12
Population: Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Sclerostin | Sclerostin, W4 | 37.30 pmol/L | Standard Deviation 9.24 |
| No Additional Physical Exercise | Sclerostin | Sclerostin, W12 | 33.96 pmol/L | Standard Deviation 7.29 |
p-value: 0.05t-test, 1 sided
Primary
Serum Sclerotin Levels
Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.
Time frame: Baseline - W4
Population: Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Serum Sclerotin Levels | Sclerostin, Baseline | 36.76 pmol/L | Standard Deviation 9.68 |
| No Additional Physical Exercise | Serum Sclerotin Levels | Sclerostin, W4 | 37.30 pmol/L | Standard Deviation 9.24 |
p-value: 0.05t-test, 1 sided
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 +).
Time frame: Baseline - Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs) | OCN+/CD34+ baseline | 1304.94 cells/ml | Standard Deviation 782.79 |
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs) | OCN+/CD34+, W4 | 1393.92 cells/ml | Standard Deviation 687.76 |
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs) | OCN+/AP+ baseline | 4485.21 cells/ml | Standard Deviation 1690.12 |
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs) | OCN+/AP+, W4 | 4512.60 cells/ml | Standard Deviation 1658.76 |
p-value: 0.05t-test, 1 sided
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 +).
Time frame: Week 4 - Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs). | OCN+/CD34+, W4 | 1393.92 cells/ml | Standard Deviation 687.76 |
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs). | OCN+/CD34+, W12 | 2311.82 cells/ml | Standard Deviation 1356.2 |
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs). | OCN+/AP+, W4 | 4512.60 cells/ml | Standard Deviation 1658.76 |
| No Additional Physical Exercise | Variation in Circulating Osteoprogenitor Cells (OPCs). | OCN+/AP+, W12 | 5062.00 cells/ml | Standard Deviation 1975.72 |
p-value: 0.05t-test, 1 sided
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
Time frame: Baseline - Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX) | sCTX baseline | 0.52 ng/mL | Standard Deviation 0.13 |
| No Additional Physical Exercise | Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX) | sCTX, W4 | 0.53 ng/mL | Standard Deviation 0.14 |
p-value: 0.05t-test, 1 sided
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
Time frame: Baseline - Week 4
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) | P1NP, W4 | 57.91 mcg/L | Standard Deviation 8.49 |
| No Additional Physical Exercise | Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) | P1NP, Baseline | 58.34 mcg/L | Standard Deviation 9.24 |
p-value: 0.05t-test, 1 sided
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.
Time frame: Week 4 - Week 12
Population: Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP). | P1NP, W4 | 57.91 mcg/L | Standard Deviation 8.49 |
| No Additional Physical Exercise | Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP). | P1NP, W12 | 64.87 mcg/L | Standard Deviation 12.67 |
p-value: 0.05t-test, 1 sided
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.
Time frame: Week 4 - Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX) | sCTX, W4 | 0.53 ng/mL | Standard Deviation 0.14 |
| No Additional Physical Exercise | Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX) | sCTX, W12 | 0.56 ng/mL | Standard Deviation 0.15 |
p-value: 0.05t-test, 1 sided
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.
Time frame: Baseline - Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Pain, Baseline | 22.59 score on a scale | Standard Deviation 17.67 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Pain, W4 | 21.97 score on a scale | Standard Deviation 19.84 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Physical function, Baseline | 9.89 score on a scale | Standard Deviation 6.89 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Physica function, W4 | 9.75 score on a scale | Standard Deviation 6.52 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Social function, Baseline | 24.38 score on a scale | Standard Deviation 11.75 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Social function, W4 | 23.77 score on a scale | Standard Deviation 12.21 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | General health perception, Baseline | 43.23 score on a scale | Standard Deviation 14.73 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | General health perception, W4 | 45.29 score on a scale | Standard Deviation 14.12 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Mental function, Baseline | 30.20 score on a scale | Standard Deviation 10.89 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Mental function, W4 | 30.09 score on a scale | Standard Deviation 9.02 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Total score, Baseline | 20.51 score on a scale | Standard Deviation 7.06 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL) | Total score, W4 | 20.70 score on a scale | Standard Deviation 7.11 |
p-value: 0.05t-test, 1 sided
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.
Time frame: Week 4 - Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Pain, W4 | 21.97 score on a scale | Standard Deviation 19.84 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Physical function, W4 | 9.75 score on a scale | Standard Deviation 6.52 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Social function, W4 | 23.77 score on a scale | Standard Deviation 12.21 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | General health perception, W4 | 45.29 score on a scale | Standard Deviation 14.12 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Mental function, W4 | 30.09 score on a scale | Standard Deviation 9.02 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Total score, W4 | 20.70 score on a scale | Standard Deviation 7.11 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Pain, W12 | 13.36 score on a scale | Standard Deviation 12.45 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Physical function, W12 | 8.13 score on a scale | Standard Deviation 6.22 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Social function, W12 | 22.10 score on a scale | Standard Deviation 12.88 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | General health perception, W12 | 41.66 score on a scale | Standard Deviation 14.47 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Mental function, W12 | 28.55 score on a scale | Standard Deviation 10.25 |
| No Additional Physical Exercise | Variation in Health-related Quality of Life (QoL). | Total score, W12 | 18.55 score on a scale | Standard Deviation 7.02 |
p-value: 0.05t-test, 1 sided