Clinical trial NCT06866561: The Effect of Aerobic Exercise on Bone Turnover Markers in Postmenopausal Patients
Official title: The Effect of Aerobic Exercise on Bone Formation and Resorption Markers And The Quality of Life Tests in Postmenopausal Osteopenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Osteopenia
Keywords: postmenopausal osteoporosis
aerobic exercise
bone turnover markers
Lead sponsor: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 45
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The serum levef of Procollagen type 1 N-terminal propeptide (P1NP) (ng/ml)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: The serum levef of Cross-linked C-telopeptide of type I collagen (CTX) (ng/ml)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: The serum levef of Osteocalcin(OCN) (ng/ml)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: The serum levef of nonbone-specific total alkaline phosphatase (ALP) (U/L)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Serum level of Malondİaldehyde(MDA) (ng/ml) as a Oxidative stress marker
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Nottingham Health Profile questionnaire (NHP)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Visual analog scale (VAS)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: 6-minute walk test (6MWT)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: International Physical Activity Questionnaire (short form)(IPAQs)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Berg Balance Scale (BBS)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: 30-second sit-to-stand test questionnaires(30s-CST)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: The serum levef of Parathyroid hormone (PTH)(pg/ml)
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Education and Research Hospital
state: Yıldırım
Study officials:
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Kübra Nur Deniz, M.D.
role: PRINCIPAL_INVESTIGATOR
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