OsteoporosisBONESNCT06606769
Physical Activity Guarantees Bone Density.
A study testing Exercise in people with Osteoporosis and Osteopenia, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
Bone tissue is crucial for overall health and quality of life, but it undergoes constant internal remodeling, leading to osteoporosis, a widespread bone disease. Regular physical activity can improve bone mineral density (BMD) and prevent osteoporosis. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 13 Sep 2024to 30 Jun 2027
- Phase
- Interventional
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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women
Who cannot join
- diagnosed osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fizyczne Aktywnosci Gwarantem Zdrowych Kosci
Bone tissue is crucial for overall health and quality of life, but it undergoes constant internal remodeling, leading to osteoporosis, a widespread bone disease. Regular physical activity can improve bone mineral density (BMD) and prevent osteoporosis. Studies have shown that premenopausal women with regular physical activity have greater BMD. Diagnosing bone resorption is essential, and dual-energy X-ray absorptiometry tests (DXA) and circulating microRNAs (miRNAs) may offer more prognostic potential than conventional markers. The gut microbiome may also regulate bone metabolism, with metabolites like trimethylamine N-oxide (TMAO) playing a role. A project aims to promote systematic physical activity to improve BMD and well-being, support societal mobilization, and conduct preventive examinations for osteoporosis risk. Implementing systematic prevention is important not only for health but also for reducing social and financial costs associated with osteoporosis and associated fractures.
Read the detailed description
Bone tissue, in addition to providing the body with supportive functions and protecting organs from injury, is a metabolically active tissue that influences the proper functioning of other organs. Therefore, bones are essential for overall health and quality of life. Bones undergo constant internal remodeling. With prolonged resorption dominance, bone mass decreases, accompanied by a deterioration of microarchitecture leading to impaired bone strength. This pathological condition is called osteoporosis and is one of the most widespread bone diseases in the world.
In recent years, there has been increasing discussion about the beneficial impact of physical activity on human health. Broadly understood physical activity affects the skeletal system, which translates into the stimulation of processes related to bone formation in the body. It is very important that exercises are performed regularly. Among premenopausal women who regularly engage in physical activity, a greater bone mineral density (BMD) has been observed compared to a group of women who do not participate in any physical activity. Therefore, there is a need to promote physical activity and to tailor physical activities according to the needs arising from both the principles of osteoporosis prevention and the age or hormonal status of women.
It is important to note that bone tissue loss is painless and progresses asymptomatically, gradually weakening the bones. Therefore, it is very important to conduct studies that diagnose the progress of bone resorption. A milestone in the diagnosis of osteoporosis is undoubtedly the dual-energy X-ray absorptiometry test. (DXA). Circulating microRNAs (miRNAs) may potentially serve as an attractive alternative or addition to the diagnostic arsenal and offer greater prognostic potential than conventional markers. Furthermore, an increasing number of studies show that the gut microbiome may be a key factor regulating bone physiology. It has been shown that bone metabolism can be regulated by metabolites dependent on the gut microbiome. The metabolite in question is trimethylamine N-oxide. (TMAO). However, so far, there have been few studies addressing the impact of TMAO on bone metabolism, as well as the underlying molecular mechanisms, and the results obtained are not conclusive.
The project aims to promote systematic physical activity that improves not only BMD but also the well-being of every individual who exercises. By increasing the availability of activation programs, this project supports the mobilization of society. Furthermore, the preventive examinations conducted among individuals qualified for the project allow for the early detection of an increased risk of developing osteoporosis. Early diagnosis of the disease prevents serious consequences in the future and increases the chances of a complete cure. At the same time, the project will undertake pioneering research aimed at enhancing the quality and excellence of the scientific and research staff.
The implementation of systematic prevention for this condition is particularly important not only in the context of health but also due to the significant social and financial costs of treating the consequences of osteoporosis and its associated fractures.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Exercise
- Keywords
- physical activity, bone mineral density
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
supervised exercise training; twice a week for 12 months
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | supervised exercise training; twice a week for 12 months Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
BMD using dual-energy X-ray absorptiometry (DXA)
Measured: before and after 12 months of intervention
Secondary outcomes (2)
blood markers
C-terminal telopeptide of type 1 collagen aminoterminal propeptide of type I procollagen trimethylamine N-oxide microRNA complete blood count
Measured: before and after 12 months of intervention
physical fitness tests
hand grip strength maximum vertical jump Chester step test
Measured: before and after 12 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start13 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A Olek, professor, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606769
- Sponsor's protocol ID
- RO_NdS_MNiSW2024
- Other IDs
- NdS-II/SP/0364/2023/01
- Acronym
- BONES
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will consider sharing individual participant data in the future