N/A
N=33
Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.
Osteopenia · Bone Turnover Markers · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT03195517 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) — 58.34; 57.91 mcg/L — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical exercise (Other)
- Age
- Adult, Older Adult · 52+ yrs
- Sex
- Female
- Sponsor
- University Of Perugia
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP) |
58.34; 57.91 | 0.05 |
| PRIMARY Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP). |
57.91; 64.87 | 0.05 |
| PRIMARY Serum Sclerotin Levels |
36.76; 37.30 | 0.05 |
| PRIMARY Sclerostin |
37.30; 33.96 | 0.05 |
| PRIMARY Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX) |
0.52; 0.53 | 0.05 |
| PRIMARY Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX) |
0.53; 0.56 | 0.05 |
| PRIMARY Variation in Circulating Osteoprogenitor Cells (OPCs) |
1304.94; 1393.92; 4485.21; 4512.60 | 0.05 |
| PRIMARY Variation in Circulating Osteoprogenitor Cells (OPCs). |
1393.92; 2311.82; 4512.60; 5062.00 | 0.05 |
| SECONDARY Variation in Health-related Quality of Life (QoL) |
22.59; 21.97; 9.89; 9.75; 24.38; 23.77 | 0.05 |
| SECONDARY Variation in Health-related Quality of Life (QoL). |
21.97; 9.75; 23.77; 45.29; 30.09; 20.70 | 0.05 |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03195517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.