Postmenopausal OsteopeniaNCT06866561
The Effect of Aerobic Exercise on Bone Turnover Markers in Postmenopausal Patients
A study testing aerobic exercise, cholecalciferol and calcium carbonate in people with Postmenopausal Osteopenia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the effect of light-moderate aerobic exercise on BMD in postmenopausal osteopenic women using bone formation-resorption markers. Participants were randomized into two groups as aerobic exercise and control groups and followed for 12 weeks. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteopenia
- What is being tested?
- aerobic exercise, cholecalciferol and calcium carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women from Türkiye aged 45-65 years,
- Bone mineral density (BMD) T-scores between -1 and -2.5 ( measured by dual-energy X-ray absorptiometry)
Who cannot join
- Vertebral compression fracture,
- A history of traumatic or nontraumatic fractures in the past year,
- Thyroid hormone disorders,
- Parathyroid hormone disorders,
- Liver function disorders,
- Kidney function disorders,
Show all 15Show fewer
- Chronic heart failure,
- A history of malignancy,
- A history of rheumatological diseases,
- Corticosteroid use,
- Immunosuppressive drug use,
- Anticonvulsant and heparin use,
- Antiresorptive or anabolic agent treatments use
- Hormone replacement therapy use
- Those who could not complete sessions due to mechanical pain exacerbated during aerobic exercise on a treadmill (such as knee and hip osteoarthritis, back pain, etc)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Education and Research Hospital
Bursa, Yıldırım, 16310
About this study
Official title: The Effect of Aerobic Exercise on Bone Formation and Resorption Markers And The Quality of Life Tests in Postmenopausal Osteopenic Patients
The aim of the study was to evaluate the effect of light-moderate aerobic exercise on BMD in postmenopausal osteopenic women using bone formation-resorption markers. Participants were randomized into two groups as aerobic exercise and control groups and followed for 12 weeks. At the beginning and at the 12th week, bone formation-resorption markers including procollagen type 1 N-terminal propeptide (P1NP), cross-linked C-telopeptide of type 1 collagen (CTX), osteocalcin, malondialdehyde, non-bone-specific total alkaline phosphatase, 25(OH)D3 and oxidative markers such as parathyroid hormone (PTH) were evaluated in serum and whether there was a difference between the 2 groups.
Read the detailed description
The aim of the study was to investigate the effects of light and moderate intensity aerobic exercise on bone mineral density (BMD) in postmenopausal osteopenic women using bone formation and resorption markers. In a prospective, randomized, controlled, single-blind clinical trial, women aged 45-65 years with BMD T scores between -1 and -2.5 measured by double X-ray absorptiometry (DXA) were included in the study after evaluation of exclusion criteria and the women were divided into 2 groups: aerobic exercise group and control group (exercise, n=25; control, n=25). The exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks. Additionally, they were shown an exercise program at the initial assessment that included balance, posture, and endurance exercises using body weight and weights to be performed 3 days a week, with 3 sets of 10 repetitions. The control group did not participate in any exercise program.All patients were prescribed 2000 IU of vitamin D (cholecalciferol) and 1200 mg of calcium carbonate daily for 12 weeks. Serum levels of biomarkers of bone formation and resorption including procollagen type 1 N-terminal propeptide (P1NP), cross-linked C-telopeptide of type 1 collagen (CTX), osteocalcin, malondialdehyde, non-bone-specific total alkaline phosphatase, 25(OH)D3 and oxidative markers such as parathyroid hormone (PTH) were examined in all patients at baseline and 12-week follow-up. Nottingham Health Profile questionnaire (NHP), Visual analog scale (VAS), 6-minute walk test (6MWT), International Physical Activity Questionnaire (short form) (IPAQ), Berg Balance Scale (BBS), 30-second sit-to-stand test questionnaires (30s-CST) tests were performed at baseline and 12 weeks to evaluate the participants' quality of daily life, pain, walking speed, physical activity level and balance.
- Conditions
- Postmenopausal Osteopenia
- Being tested
- aerobic exercise, cholecalciferol, calcium carbonate
- Keywords
- postmenopausal osteoporosis, aerobic exercise, bone turnover markers
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
The exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks. Additionally, they were shown an exercise program at the initial assessment that included balance, posture, and endurance exercises using body weight and weights to be performed 3 days a week, with 3 sets of 10 repetitions. The control group did not participate in any exercise program.
cholecalciferolOther
Participants were prescribed 2000 IU of vitamin D (cholecalciferol) daily for 12 weeks.
calcium carbonateOther
Participants were prescribed 1200 mg of calcium carbonate daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Active comparator | The exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks. Receives: Other: aerobic exercise; Other: cholecalciferol; Other: calcium carbonate |
| Control group | Other | The control group did not participate in any exercise program. Receives: Other: cholecalciferol; Other: calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The serum levef of Procollagen type 1 N-terminal propeptide (P1NP) (ng/ml)
Bone turnover markers allow for the independent assessment of bone resorption and formation by measuring their concentrations in blood and urine. These markers provide early response evaluation posttreatment of osteoporosis compared to measuring BMD. The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend evaluating P1NP for bone formation activity and evaluating CTX-1 concentrations for bone resorption activity. In the study,the investigators chose walking exercise as an aerobic exercise that can be easily applied to people of all age groups and those with comorbidities. For these reasons, as the primary outcome of the study, the investigators aimed to measure the effects of aerobic exercise as a treatment method that can be recommended to the majority of patients, as bone turnover markers P1NP, CTX, OCN and total ALP respond quickly to treatment.
Measured: From enrollment to the end of treatment at 12 weeks
The serum levef of Cross-linked C-telopeptide of type I collagen (CTX) (ng/ml)
During bone resorption, components of bone tissue are catabolized by osteoclasts. The released components are released into the bone microenvironment and secreted into the bloodstream. Some of them are also excreted in the urine. The level of C-telopeptide type 1 collagen(CTX)(ng/ml) can be measured in serum from these products. . The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend evaluating CTX-1 concentrations for bone resorption activity.
Measured: From enrollment to the end of treatment at 12 weeks
The serum levef of Osteocalcin(OCN) (ng/ml)
During bone formation, osteoblasts fill the cavities with collagen-rich tissue and the molecules formed during their production are secreted into the blood. These products are; Type 1 procollagen N-terminal propeptide (P1NP), bone alkaline phosphatase, Osteocalcin, Type-1 procollagen C-terminal propeptide. These molecules also show bone formation activity.
Measured: From enrollment to the end of treatment at 12 weeks
The serum levef of nonbone-specific total alkaline phosphatase (ALP) (U/L)
During bone formation, osteoblasts fill the cavities with collagen-rich tissue and the molecules formed during their production are secreted into the blood. These products are; Type 1 procollagen N-terminal propeptide (P1NP), bone alkaline phosphatase, Osteocalcin, Type-1 procollagen C-terminal propeptide. These molecules also show bone formation activity.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (8)
Serum level of Malondİaldehyde(MDA) (ng/ml) as a Oxidative stress marker
Oxidative stress is considered an important pathogenic factor of osteoporosis at the cellular and molecular level. It induces osteocyte apoptosis and altered levels of specific factors such as receptor activator κB ligand (RANKL), sclerostin and fibroblast growth factor 23, leading to impaired bone remodeling and increased bone resorption. Increased osteoclastic activity occurring in osteoporosis results in increased production of ROS in the form of superoxide. Lipid peroxidation is one of the most deleterious effects of ROS, and the end product of lipid peroxidation, malondialdehyde (MDA), also serves as a measure of osteoclastic activity. For this reason, increased levels of MDA as a marker of oxidative stress can be detected in individuals with osteoporosis. In the study, the investigators aimed to observe the changes in the serum level of malondialdehyde, one of the oxidative stress markers, with aerobic exercise.
Measured: From enrollment to the end of treatment at 12 weeks
Nottingham Health Profile questionnaire (NHP)
Nottingham Health Profile questionnaire (NHP) was used to measure patients' quality of life. NHP consists of section 1 consisting of 38 detailed questions about health and section 2 consisting of 7 questions about the areas of daily life most affected by health. Section 1 questions 6 areas related to health in detail: pain, emotional reactions, sleep, social isolation, physical activity, energy. Each subsection is evaluated between 0-100 points. Section 2 consists of seven statements about the areas of daily life most affected by health: work, daily chores at home, social life, personal relationships, sexual life, hobbies-interests, and holidays. Here, patients are evaluated between 0-7 points, with 1 point for each statement. Patients were evaluated between 0-600 points for section 1, 0-7 points for section 2, and 0-607 points as the NHP Total score.
Measured: From enrollment to the end of treatment at 12 weeks
Visual analog scale (VAS)
Visual analog scale (VAS) was used to evaluate and monitor the level of pain felt by the patients. The investigators aimed to evaluate the pain level of patients after exercise with VAS.Patients were asked to mark on a 100 mm long line divided into 10 units and numbered from 0 to 10; 0 (zero) "I have no pain", 10 "the most severe pain I have ever felt". The number marked was recorded as the VAS pain score.
Measured: From enrollment to the end of treatment at 12 weeks
6-minute walk test (6MWT)
6-minute walk test (6MWT) was used to assess the functional capacity of patients and is a valid and reliable test as an indicator of physical endurance in elderly individuals. The investigators aimed to evaluate the functional capacity of patients after exercise with 6MWT.
Measured: From enrollment to the end of treatment at 12 weeks
International Physical Activity Questionnaire (short form)(IPAQs)
The International Physical Activity Questionnaire (short form) (IPAQs) is used to assess daily physical activity levels. IPAQs consist of 7 questions that assess the time patients spent physically in the last 7 days. These questions assess physical activity in 2 categories: vigorous, moderate and low-level physical activity or weekly MET/minute. MET/minute indicates the amount of energy expended while performing physical activity. While IPAQs are calculated as weekly METs, 3.3 METs are calculated for a minute of low-level physical activity; 4 METs for moderate-level physical activities; 8 METs for a minute of vigorous physical activities. Expending 1500-3000 METs of energy in 1 week is considered vigorous physical activity; 600-1500 METs is considered moderate physical activity, and individuals with less than 600 METs are considered in the light physical activity group. The investigators aimed to assess participants' post-exercise physical activity levels with IPAQs.
Measured: From enrollment to the end of treatment at 12 weeks
Berg Balance Scale (BBS)
Berg Balance Scale (BBS) is a 14-question test used to evaluate the balance and fall risk of elderly individuals. Each item is scored between 0-4 according to the patient's level and speed of performing the desired movement. Patients were evaluated between 0-56 points in total. 0-20 points indicate balance disorder, 21-40 points indicate acceptable balance, and 41-56 points indicate good balance. The investigators aimed to evaluate the balance level of patients after exercise with BBS.
Measured: From enrollment to the end of treatment at 12 weeks
30-second sit-to-stand test questionnaires(30s-CST)
30-second sit-to-stand test questionnaires(30s-CST) evaluates the patient's lower extremity strength and dynamic balance during activity. The investigators aimed to evaluate the lower extremity strength and dynamic balance of the patients after exercise.
Measured: From enrollment to the end of treatment at 12 weeks
The serum levef of Parathyroid hormone (PTH)(pg/ml)
Parathyroid hormone (PTH) plays an important role in regulating calcium and phosphorus metabolism in the body by acting directly on human bones and kidneys and indirectly on the human intestine. In doing so, it affects both bone formation and bone resorption.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Nov 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who met the inclusion criteria were randomized into 2 groups with the investigator blinded. Participants in the exercise group were included in an aerobic exercise program, while patients in the control group were not included in any exercise program. All patients underwent serum marker assessment and clinical examination both at baseline and after 12 weeks of follow-up.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, KÜBRA NUR DENİZ, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Kübra Nur Deniz, M.D., Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866561
- Sponsor's protocol ID
- HSBY-FTR-KND-01
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are provided within the manuscript and supplementary information file.
Publications
Zhou Q, Zhu L, Zhang D, Li N, Li Q, Dai P, Mao Y, Li X, Ma J, Huang S. Oxidative Stress-Related Biomarkers in Postmenopausal Osteoporosis: A Systematic Review and Meta-Analyses. Dis Markers. 2016;2016:7067984. doi: 10.1155/2016/7067984. Epub 2016 Aug 10.
PubMed 27594735Voulgaridou G, Papadopoulou SK, Detopoulou P, Tsoumana D, Giaginis C, Kondyli FS, Lymperaki E, Pritsa A. Vitamin D and Calcium in Osteoporosis, and the Role of Bone Turnover Markers: A Narrative Review of Recent Data from RCTs. Diseases. 2023 Feb 8;11(1):29. doi: 10.3390/diseases11010029.
PubMed 36810543Eastell R, Garnero P, Audebert C, Cahall DL. Reference intervals of bone turnover markers in healthy premenopausal women: results from a cross-sectional European study. Bone. 2012 May;50(5):1141-7. doi: 10.1016/j.bone.2012.02.003. Epub 2012 Feb 12.
PubMed 22348982Siwapituk W, Kitisomprayoonkul W. Bone turnover increases during supervised treadmill walking in Thai postmenopausal women. Osteoporos Sarcopenia. 2016 Mar;2(1):41-44. doi: 10.1016/j.afos.2016.02.005. Epub 2016 Mar 21.
PubMed 30775467FilipoviC TN, LazoviC MP, BackoviC AN, FilipoviC AN, IgnjatoviC AM, DimitrijeviC SS, GopCeviC KR. A 12-week exercise program improves functional status in postmenopausal osteoporotic women: randomized controlled study. Eur J Phys Rehabil Med. 2021 Feb;57(1):120-130. doi: 10.23736/S1973-9087.20.06149-3. Epub 2020 Sep 9.
PubMed 32902207Hettchen M, von Stengel S, Kohl M, Murphy MH, Shojaa M, Ghasemikaram M, Bragonzoni L, Benvenuti F, Ripamonti C, Benedetti MG, Julin M, Risto T, Kemmler W. Changes in Menopausal Risk Factors in Early Postmenopausal Osteopenic Women After 13 Months of High-Intensity Exercise: The Randomized Controlled ACTLIFE-RCT. Clin Interv Aging. 2021 Jan 11;16:83-96. doi: 10.2147/CIA.S283177. eCollection 2021.
PubMed 33469276Zhang L, Zheng YL, Wang R, Wang XQ, Zhang H. Exercise for osteoporosis: A literature review of pathology and mechanism. Front Immunol. 2022 Sep 9;13:1005665. doi: 10.3389/fimmu.2022.1005665. eCollection 2022.
PubMed 36164342Cariati I, Bonanni R, Onorato F, Mastrogregori A, Rossi D, Iundusi R, Gasbarra E, Tancredi V, Tarantino U. Role of Physical Activity in Bone-Muscle Crosstalk: Biological Aspects and Clinical Implications. J Funct Morphol Kinesiol. 2021 Jun 21;6(2):55. doi: 10.3390/jfmk6020055.
PubMed 34205747Shoback D, Rosen CJ, Black DM, Cheung AM, Murad MH, Eastell R. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgaa048. doi: 10.1210/clinem/dgaa048.
PubMed 32068863Eriksen EF. Treatment of osteopenia. Rev Endocr Metab Disord. 2012 Sep;13(3):209-23. doi: 10.1007/s11154-011-9187-z.
PubMed 21710179Kaplan AA. A simple and accurate method for prescribing plasma exchange. ASAIO Trans. 1990 Jul-Sep;36(3):M597-9.
PubMed 2252761Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Hunt SM, McEwen J, McKenna SP. Measuring health status: a new tool for clinicians and epidemiologists. J R Coll Gen Pract. 1985 Apr;35(273):185-8.
PubMed 3989783Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
PubMed 10826123Yang S, Feskanich D, Willett WC, Eliassen AH, Wu T. Association between global biomarkers of oxidative stress and hip fracture in postmenopausal women: a prospective study. J Bone Miner Res. 2014 Dec;29(12):2577-83. doi: 10.1002/jbmr.2302.
PubMed 24957524
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise on Bone Formation and Resorption Markers And The Quality of Life Tests in Postmenopausal Osteopenic Patients
- ClinicalTrials.gov ID
- NCT06866561
- Acronym / sponsor ID
- HSBY-FTR-KND-01
- Conditions
- Postmenopausal Osteopenia
- Keywords
- postmenopausal osteoporosis, aerobic exercise, bone turnover markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to evaluate the effect of light-moderate aerobic exercise on BMD in postmenopausal osteopenic women using bone formation-resorption markers. Participants were randomized into two groups as aerobic exercise and control groups and followed for 12 weeks. At the beginning and at the 12th week, bone formation-resorption markers including procollagen type 1 N-terminal propeptide (P1NP), cross-linked C-telopeptide of type 1 collagen (CTX), osteocalcin, malondialdehyde, non-bone-specific total alkaline phosphatase, 25(OH)D3 and oxidative markers such as parathyroid hormone (PTH) were evaluated in serum and whether there was a difference between the 2 groups.
Detailed description
The aim of the study was to investigate the effects of light and moderate intensity aerobic exercise on bone mineral density (BMD) in postmenopausal osteopenic women using bone formation and resorption markers. In a prospective, randomized, controlled, single-blind clinical trial, women aged 45-65 years with BMD T scores between -1 and -2.5 measured by double X-ray absorptiometry (DXA) were included in the study after evaluation of exclusion criteria and the women were divided into 2 groups: aerobic exercise group and control group (exercise, n=25; control, n=25). The exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks. Additionally, they were shown an exercise program at the initial assessment that included balance, posture, and endurance exercises using body weight and weights to be performed 3 days a week, with 3 sets of 10 repetitions. The control group did not participate in any exercise program.All patients were prescribed 2000 IU of vitamin D (cholecalciferol) and 1200 mg of calcium carbonate daily for 12 weeks. Serum levels of biomarkers of bone formation and resorption including procollagen type 1 N-terminal propeptide (P1NP), cross-linked C-telopeptide of type 1 collagen (CTX), osteocalcin, malondialdehyde, non-bone-specific total alkaline phosphatase, 25(OH)D3 and oxidative markers such as parathyroid hormone (PTH) were examined in all patients at baseline and 12-week follow-up. Nottingham Health Profile questionnaire (NHP), Visual analog scale (VAS), 6-minute walk test (6MWT), International Physical Activity Questionnaire (short form) (IPAQ), Berg Balance Scale (BBS), 30-second sit-to-stand test questionnaires (30s-CST) tests were performed at baseline and 12 weeks to evaluate the participants' quality of daily life, pain, walking speed, physical activity level and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients who met the inclusion criteria were randomized into 2 groups with the investigator blinded. Participants in the exercise group were included in an aerobic exercise program, while patients in the control group were not included in any exercise program. All patients underwent serum marker assessment and clinical examination both at baseline and after 12 weeks of follow-up.
| Arm | Type | Receives |
|---|---|---|
| exercise group | Active comparator | Other: aerobic exercise, Other: cholecalciferol, Other: calcium carbonateThe exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks. |
| Control group | Other | Other: cholecalciferol, Other: calcium carbonateThe control group did not participate in any exercise program. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women from Türkiye aged 45-65 years,
- Bone mineral density (BMD) T-scores between -1 and -2.5 ( measured by dual-energy X-ray absorptiometry)
Key exclusion criteria (15 listed)
- Vertebral compression fracture,
- A history of traumatic or nontraumatic fractures in the past year,
- Thyroid hormone disorders,
- Parathyroid hormone disorders,
- Liver function disorders,
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 |
|---|---|---|
| aerobic exerciseThe exercise group participated in a supervised aerobic exercise program consisting of walking on a treadmill for 30 minutes per day, 3 days per week, at an intensity of 40-60% of maximal heart rate for 4 weeks. Additionally, they were shown an exercise program at the initial assessment that included balance, posture, and endurance exercises using body weight and weights to be performed 3 days a week, with 3 sets of 10 repetitions. The control group did not participate in any exercise program. | Other | exercise group |
| cholecalciferolParticipants were prescribed 2000 IU of vitamin D (cholecalciferol) daily for 12 weeks. | Other | Control group, exercise group |
| calcium carbonateParticipants were prescribed 1200 mg of calcium carbonate daily for 12 weeks. | Other | Control group, exercise group |
Primary outcome
The serum levef of Procollagen type 1 N-terminal propeptide (P1NP) (ng/ml)
Time frame: From enrollment to the end of treatment at 12 weeks
Bone turnover markers allow for the independent assessment of bone resorption and formation by measuring their concentrations in blood and urine. These markers provide early response evaluation posttreatment of osteoporosis compared to measuring BMD. The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend evaluating P1NP for bone formation activity and evaluating CTX-1 concentrations for bone resorption activity. In the study,the investigators chose walking exercise as an aerobic exercise that can be easily applied to people of all age groups and those with comorbidities. For these reasons, as the primary outcome of the study, the investigators aimed to measure the effects of aerobic exercise as a treatment method that can be recommended to the majority of patients, as bone turnover markers P1NP, CTX, OCN and total ALP respond quickly to treatment.
The serum levef of Cross-linked C-telopeptide of type I collagen (CTX) (ng/ml)
Time frame: From enrollment to the end of treatment at 12 weeks
During bone resorption, components of bone tissue are catabolized by osteoclasts. The released components are released into the bone microenvironment and secreted into the bloodstream. Some of them are also excreted in the urine. The level of C-telopeptide type 1 collagen(CTX)(ng/ml) can be measured in serum from these products. . The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend evaluating CTX-1 concentrations for bone resorption activity.
The serum levef of Osteocalcin(OCN) (ng/ml)
Time frame: From enrollment to the end of treatment at 12 weeks
During bone formation, osteoblasts fill the cavities with collagen-rich tissue and the molecules formed during their production are secreted into the blood. These products are; Type 1 procollagen N-terminal propeptide (P1NP), bone alkaline phosphatase, Osteocalcin, Type-1 procollagen C-terminal propeptide. These molecules also show bone formation activity.
The serum levef of nonbone-specific total alkaline phosphatase (ALP) (U/L)
Time frame: From enrollment to the end of treatment at 12 weeks
During bone formation, osteoblasts fill the cavities with collagen-rich tissue and the molecules formed during their production are secreted into the blood. These products are; Type 1 procollagen N-terminal propeptide (P1NP), bone alkaline phosphatase, Osteocalcin, Type-1 procollagen C-terminal propeptide. These molecules also show bone formation activity.
8 secondary outcomes
Serum level of Malondİaldehyde(MDA) (ng/ml) as a Oxidative stress marker
Time frame: From enrollment to the end of treatment at 12 weeks
Nottingham Health Profile questionnaire (NHP)
Time frame: From enrollment to the end of treatment at 12 weeks
Visual analog scale (VAS)
Time frame: From enrollment to the end of treatment at 12 weeks
6-minute walk test (6MWT)
Time frame: From enrollment to the end of treatment at 12 weeks
International Physical Activity Questionnaire (short form)(IPAQs)
Time frame: From enrollment to the end of treatment at 12 weeks
Berg Balance Scale (BBS)
Time frame: From enrollment to the end of treatment at 12 weeks
30-second sit-to-stand test questionnaires(30s-CST)
Time frame: From enrollment to the end of treatment at 12 weeks
The serum levef of Parathyroid hormone (PTH)(pg/ml)
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 27594735Zhou Q, Zhu L, Zhang D, Li N, Li Q, Dai P, Mao Y, Li X, Ma J, Huang S. Oxidative Stress-Related Biomarkers in Postmenopausal Osteoporosis: A Systematic Review and Meta-Analyses. Dis Markers. 2016;2016:7067984. doi: 10.1155/2016/7067984. Epub 2016 Aug 10.
- Results publication: PubMed 36810543Voulgaridou G, Papadopoulou SK, Detopoulou P, Tsoumana D, Giaginis C, Kondyli FS, Lymperaki E, Pritsa A. Vitamin D and Calcium in Osteoporosis, and the Role of Bone Turnover Markers: A Narrative Review of Recent Data from RCTs. Diseases. 2023 Feb 8;11(1):29. doi: 10.3390/diseases11010029.
- Results publication: PubMed 22348982Eastell R, Garnero P, Audebert C, Cahall DL. Reference intervals of bone turnover markers in healthy premenopausal women: results from a cross-sectional European study. Bone. 2012 May;50(5):1141-7. doi: 10.1016/j.bone.2012.02.003. Epub 2012 Feb 12.
- Results publication: PubMed 30775467Siwapituk W, Kitisomprayoonkul W. Bone turnover increases during supervised treadmill walking in Thai postmenopausal women. Osteoporos Sarcopenia. 2016 Mar;2(1):41-44. doi: 10.1016/j.afos.2016.02.005. Epub 2016 Mar 21.
- Results publication: PubMed 32902207FilipoviC TN, LazoviC MP, BackoviC AN, FilipoviC AN, IgnjatoviC AM, DimitrijeviC SS, GopCeviC KR. A 12-week exercise program improves functional status in postmenopausal osteoporotic women: randomized controlled study. Eur J Phys Rehabil Med. 2021 Feb;57(1):120-130. doi: 10.23736/S1973-9087.20.06149-3. Epub 2020 Sep 9.
- Results publication: PubMed 33469276Hettchen M, von Stengel S, Kohl M, Murphy MH, Shojaa M, Ghasemikaram M, Bragonzoni L, Benvenuti F, Ripamonti C, Benedetti MG, Julin M, Risto T, Kemmler W. Changes in Menopausal Risk Factors in Early Postmenopausal Osteopenic Women After 13 Months of High-Intensity Exercise: The Randomized Controlled ACTLIFE-RCT. Clin Interv Aging. 2021 Jan 11;16:83-96. doi: 10.2147/CIA.S283177. eCollection 2021.
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- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are provided within the manuscript and supplementary information file.
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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.
Kübra Nur Deniz, M.D. principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise, cholecalciferol and calcium carbonate in people with Postmenopausal Osteopenia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 15 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The serum levef of Procollagen type 1 N-terminal propeptide (P1NP) (ng/ml) (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 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 NCT06866561, which also lists 30 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 12 Mar 2025.