The Effect of Aerobic Exercise on Bone Turnover Markers in Postmenopausal Patients

NCT ID: NCT06866561

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-11-15

Brief Summary

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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

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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

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Postmenopausal Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Patients who met the inclusion criteria were randomized into 2 groups with the investigator blinded.

Study Groups

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exercise group

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.

Group Type ACTIVE_COMPARATOR

aerobic exercise

Intervention Type OTHER

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.

cholecalciferol

Intervention Type OTHER

Participants were prescribed 2000 IU of vitamin D (cholecalciferol) daily for 12 weeks.

calcium carbonate

Intervention Type OTHER

Participants were prescribed 1200 mg of calcium carbonate daily for 12 weeks.

Control group

The control group did not participate in any exercise program.

Group Type OTHER

cholecalciferol

Intervention Type OTHER

Participants were prescribed 2000 IU of vitamin D (cholecalciferol) daily for 12 weeks.

calcium carbonate

Intervention Type OTHER

Participants were prescribed 1200 mg of calcium carbonate daily for 12 weeks.

Interventions

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aerobic exercise

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.

Intervention Type OTHER

cholecalciferol

Participants were prescribed 2000 IU of vitamin D (cholecalciferol) daily for 12 weeks.

Intervention Type OTHER

calcium carbonate

Participants were prescribed 1200 mg of calcium carbonate daily for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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,
* 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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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KÜBRA NUR DENİZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kübra Nur Deniz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

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Bursa Yüksek İhtisas Education and Research Hospital

Bursa, Yıldırım, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 27594735 (View on PubMed)

Voulgaridou 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.

Reference Type RESULT
PMID: 36810543 (View on PubMed)

Eastell 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.

Reference Type RESULT
PMID: 22348982 (View on PubMed)

Siwapituk 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.

Reference Type RESULT
PMID: 30775467 (View on PubMed)

FilipoviC 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.

Reference Type RESULT
PMID: 32902207 (View on PubMed)

Hettchen 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.

Reference Type RESULT
PMID: 33469276 (View on PubMed)

Zhang 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.

Reference Type RESULT
PMID: 36164342 (View on PubMed)

Cariati 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.

Reference Type RESULT
PMID: 34205747 (View on PubMed)

Shoback 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.

Reference Type RESULT
PMID: 32068863 (View on PubMed)

Eriksen EF. Treatment of osteopenia. Rev Endocr Metab Disord. 2012 Sep;13(3):209-23. doi: 10.1007/s11154-011-9187-z.

Reference Type RESULT
PMID: 21710179 (View on PubMed)

Kaplan AA. A simple and accurate method for prescribing plasma exchange. ASAIO Trans. 1990 Jul-Sep;36(3):M597-9.

Reference Type RESULT
PMID: 2252761 (View on PubMed)

Price 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.

Reference Type RESULT
PMID: 6226917 (View on PubMed)

Hunt 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.

Reference Type RESULT
PMID: 3989783 (View on PubMed)

Kucukdeveci 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.

Reference Type RESULT
PMID: 10826123 (View on PubMed)

Yang 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.

Reference Type RESULT
PMID: 24957524 (View on PubMed)

Zhao F, Guo L, Wang X, Zhang Y. Correlation of oxidative stress-related biomarkers with postmenopausal osteoporosis: a systematic review and meta-analysis. Arch Osteoporos. 2021 Jan 5;16(1):4. doi: 10.1007/s11657-020-00854-w.

Reference Type RESULT
PMID: 33400044 (View on PubMed)

Marcucci G, Domazetovic V, Nediani C, Ruzzolini J, Favre C, Brandi ML. Oxidative Stress and Natural Antioxidants in Osteoporosis: Novel Preventive and Therapeutic Approaches. Antioxidants (Basel). 2023 Feb 3;12(2):373. doi: 10.3390/antiox12020373.

Reference Type RESULT
PMID: 36829932 (View on PubMed)

Vasikaran S, Cooper C, Eastell R, Griesmacher A, Morris HA, Trenti T, Kanis JA. International Osteoporosis Foundation and International Federation of Clinical Chemistry and Laboratory Medicine position on bone marker standards in osteoporosis. Clin Chem Lab Med. 2011 Aug;49(8):1271-1274. doi: 10.1515/CCLM.2011.602. Epub 2011 May 24.

Reference Type RESULT
PMID: 21605012 (View on PubMed)

Mohr M, Helge EW, Petersen LF, Lindenskov A, Weihe P, Mortensen J, Jorgensen NR, Krustrup P. Effects of soccer vs swim training on bone formation in sedentary middle-aged women. Eur J Appl Physiol. 2015 Dec;115(12):2671-9. doi: 10.1007/s00421-015-3231-8. Epub 2015 Aug 9.

Reference Type RESULT
PMID: 26255288 (View on PubMed)

Jain S, Camacho P. Use of bone turnover markers in the management of osteoporosis. Curr Opin Endocrinol Diabetes Obes. 2018 Dec;25(6):366-372. doi: 10.1097/MED.0000000000000446.

Reference Type RESULT
PMID: 30299435 (View on PubMed)

Lorentzon M, Branco J, Brandi ML, Bruyere O, Chapurlat R, Cooper C, Cortet B, Diez-Perez A, Ferrari S, Gasparik A, Herrmann M, Jorgensen NR, Kanis J, Kaufman JM, Laslop A, Locquet M, Matijevic R, McCloskey E, Minisola S, Pikner R, Reginster JY, Rizzoli R, Szulc P, Vlaskovska M, Cavalier E. Algorithm for the Use of Biochemical Markers of Bone Turnover in the Diagnosis, Assessment and Follow-Up of Treatment for Osteoporosis. Adv Ther. 2019 Oct;36(10):2811-2824. doi: 10.1007/s12325-019-01063-9. Epub 2019 Aug 22.

Reference Type RESULT
PMID: 31440982 (View on PubMed)

Greenblatt MB, Tsai JN, Wein MN. Bone Turnover Markers in the Diagnosis and Monitoring of Metabolic Bone Disease. Clin Chem. 2017 Feb;63(2):464-474. doi: 10.1373/clinchem.2016.259085. Epub 2016 Dec 9.

Reference Type RESULT
PMID: 27940448 (View on PubMed)

Eastell R, Szulc P. Use of bone turnover markers in postmenopausal osteoporosis. Lancet Diabetes Endocrinol. 2017 Nov;5(11):908-923. doi: 10.1016/S2213-8587(17)30184-5. Epub 2017 Jul 7.

Reference Type RESULT
PMID: 28689768 (View on PubMed)

Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD000333. doi: 10.1002/14651858.CD000333.pub2.

Reference Type RESULT
PMID: 21735380 (View on PubMed)

Todd JA, Robinson RJ. Osteoporosis and exercise. Postgrad Med J. 2003 Jun;79(932):320-3. doi: 10.1136/pmj.79.932.320.

Reference Type RESULT
PMID: 12840119 (View on PubMed)

Benedetti MG, Furlini G, Zati A, Letizia Mauro G. The Effectiveness of Physical Exercise on Bone Density in Osteoporotic Patients. Biomed Res Int. 2018 Dec 23;2018:4840531. doi: 10.1155/2018/4840531. eCollection 2018.

Reference Type RESULT
PMID: 30671455 (View on PubMed)

NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy. JAMA. 2001 Feb 14;285(6):785-95. doi: 10.1001/jama.285.6.785.

Reference Type RESULT
PMID: 11176917 (View on PubMed)

Tu KN, Lie JD, Wan CKV, Cameron M, Austel AG, Nguyen JK, Van K, Hyun D. Osteoporosis: A Review of Treatment Options. P T. 2018 Feb;43(2):92-104.

Reference Type RESULT
PMID: 29386866 (View on PubMed)

Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993 Jun;94(6):646-50. doi: 10.1016/0002-9343(93)90218-e. No abstract available.

Reference Type RESULT
PMID: 8506892 (View on PubMed)

Deniz KN, Aksoy MK. "The effect of aerobic exercise on bone formation and resorption markers and the quality of life tests in postmenopausal osteopenic patients". BMC Musculoskelet Disord. 2025 Apr 21;26(1):385. doi: 10.1186/s12891-025-08578-z.

Reference Type DERIVED
PMID: 40259282 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSBY-FTR-KND-01

Identifier Type: -

Identifier Source: org_study_id

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