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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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.

Poland1 site
  • Poznan University of Physical Education

    Poznan, 61-871

Other trials in Poland

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.

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 groups in NCT06606769
Study groupRoleWhat they receive
exerciseExperimentalsupervised 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.

  1. bone mineral density

    BMD using dual-energy X-ray absorptiometry (DXA)

    Measured: before and after 12 months of intervention

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted23 Sep 2024
  2. Study start13 Sep 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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)
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

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