OsteoporosisPhase 1/2SBNCT06843486
SB: Promoting Bone Health in Women
A Phase 1/2 study testing Multicomponent Exercise in people with Osteoporosis, run by Instituto Politécnico de Bragança at 1 site in Portugal.
Trial summary
The goal of this clinical trial is to find out whether multicomponent training works to treat osteoporosis in women. It will also find out about the safety of multicomponent training in this specific population. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Multicomponent Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2024to 2 May 2025
- Phase
- Phase 1/2
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: Women over 65 years of age. Clinical diagnosis:
- Previous diagnosis of osteoporosis confirmed by DXA (T-score between -1.0 and -2.5 for osteopenia and ≤ -2.5 for osteoporosis).
- Ability to exercise: Medical clearance to participate in the exercise program. and ability to perform moderate-impact physical activities and muscular endurance.
- Level of physical activity: Sedentary women or women with low to moderate levels of physical activity, without regular practice of specific exercises for bone health in the last 6 months.
- Agreement to the study: Signing of the Free and Informed Consent Form (FICF) and availability to participate in the training program for 6 months.
Who cannot join
- Advanced clinical diagnosis: T-score below -3.0 (severe osteoporosis with high risk of fractures); History of severe osteoporotic fracture in the last 6 months.
- Associated diseases or conditions: Uncontrolled metabolic or endocrine diseases that affect bone metabolism (e.g., hyperparathyroidism, Cushing's syndrome, decompensated diabetes); Active chronic inflammatory diseases (e.g., advanced rheumatoid arthritis, systemic lupus erythematosus); Severe chronic renal failure (stages 4 or 5).
- Use of specific medications in the last 12 months: Bisphosphonates, denosumab, teriparatide or strontium ranelate; High-dose glucocorticoids (>5 mg/day for more than 3 months); Recent hormone therapy for osteoporosis.
- Orthopedic or neuromuscular conditions: Severe functional limitation that prevents the performance of physical exercises (e.g., severe osteoarthritis, advanced joint instability, neurological sequelae of stroke); Orthopedic surgery in the last 6 months or indication for elective surgery for the spine or lower limbs.
- Factors that limit adherence to the study: Difficulty in moving that prevents participation in in-person training (for the in-person MCT group); Lack of availability to attend sessions or follow the study protocol; History of low adherence to previous health-related interventions.
- Participation in another clinical study: Women enrolled in clinical trials that may interfere with the results of the study or adherence to the protocol.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto Politécnico de Bragança
Bragança, Braganza District, 5300-253
About this study
Official title: Strong Bones: Promoting Bone Health and Quality of Life in Postmenopausal Women.
The goal of this clinical trial is to find out whether multicomponent training works to treat osteoporosis in women. It will also find out about the safety of multicomponent training in this specific population. The main questions it aims to answer are:
Does multicomponent training improve bone mineral density in women?
Read more
What are the benefits of multicomponent training?
The researchers will compare the intervention group (MTC) with a control group that did not perform any type of intervention, to see if MTC training works in treating bone mineral density in women.
The participants will:
Perform MTC training for 6 months with a frequency of 3 times a week in sessions of 40-60 minutes. While the control group will carry out their daily activities normally and will only attend on the days of the assessments.
Read the detailed description
The Strong Bones Project is a randomized controlled trial (RCT) investigating the effects of Multicomponent Training (MCT) on bone mineral density (BMD), quality of life, and risk of osteoporosis in women.
The study adopts a hybrid approach combining cross-sectional observational analyses and randomized experimental interventions. Participants will be randomly allocated to an intervention group and a control group, allowing comparison of the impacts of MCT.
The interventions include a structured physical exercise program, with three distinct approaches:
- In-Person Supervised Multicomponent Training (MCT In-Person)
- Control Group (No active intervention, only clinical monitoring)
Training sessions will include aerobic, resistance, balance, and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention.
Data collection will include:
- Sociodemographic data
- Bone mineral density (BMD), assessed by DXA (Dual-Energy X-ray Absorptiometry)
- Functional fitness tests (e.g. handgrip strength test)
Participants will be followed for 6 months, with monthly assessments to monitor the progression of clinical variables.
Expected results include improved bone density, reduced risk of fractures, and improved quality of life.
The findings will be disseminated through scientific publications in peer-reviewed journals and presentations at international conferences on bone health and physical exercise.
This study seeks to contribute to the formulation of personalized physical exercise guidelines for the prevention of osteoporosis, especially in premenopausal women and men at intermediate risk of the disease.
- Conditions
- Osteoporosis
- Being tested
- Multicomponent Exercise
- Keywords
- Osteoporosis, Womens, Menopause
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent ExerciseOther
Training sessions will include aerobic, resistance, balance and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The group will not receive any type of intervention |
| Multicomponent Exercise | Experimental | Participants receive an intervention (a multi-component exercise program). Receives: Other: Multicomponent Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density (BMD)
Bone mineral density (BMD), measured in g/cm², assesses regions such as the lumbar spine, proximal femur, and total body. It is used to diagnose and monitor osteopenia and osteoporosis based on WHO criteria. The T-score, expressed in standard deviations (SD), compares the patient's BMD to that of a young, healthy population, classifying osteopenia (T-score -1.0 to -2.5 SD) and osteoporosis (T-score ≤ -2.5 SD). The Z-score compares BMD to age- and sex-matched averages, aiding in identifying secondary causes of osteoporosis.
Dual-energy X-ray absorptiometry (DXA) is the standard method for measuring BMD. Additionally, DXA provides body composition analysis, offering data on bone mass (grams), lean mass (grams/kilograms), and body fat percentage (%). These parameters enable a comprehensive assessment of musculoskeletal health and nutritional status.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (6)
Lower Limb Strength
Test: 30-Second Chair Stand Description: Participants sit on a standard chair (43 cm height) and stand up as many times as possible within 30 seconds, without using their arms for support.
Unit of Measure: Number of repetitions in 30 seconds
Measured: From enrollment to the end of treatment at 6 months
Upper Limb Strength
Test: Arm Curl Test Description: Participants perform as many full biceps curls as possible within 30 seconds while holding a dumbbell (2.27 kg for women).
Unit of Measure: Number of repetitions in 30 seconds
Measured: From enrollment to the end of treatment at 6 months
Lower Limb Flexibility
Test: Chair Sit-and-Reach Test Description: Participants sit on the edge of a chair with one leg extended and reach toward their toes.
Unit of Measure: Distance between fingers and toes (centimeters)
Measured: From enrollment to the end of treatment at 6 months
Upper Limb Flexibility
Test: Back Scratch Test Description: Participants attempt to touch their fingertips behind their back, reaching one arm over the shoulder and the other behind the back.
Unit of Measure: Distance between middle fingers (centimeters)
Measured: From enrollment to the end of treatment at 6 months
Agility/Balance
Test: Timed Up and Go (TUG) Test Description: Participants stand up from a chair, walk 2.45 meters, turn around, and return to the seated position as quickly as possible.
Unit of Measure: Time to complete the test (seconds)
Measured: From enrollment to the end of treatment at 6 months
Aerobic Endurance
Test: 2-Minute Step Test Description: Participants march in place for two minutes, ensuring that their knee reaches a predefined height (midpoint between patella and iliac crest).
Unit of Measure: Number of times the right knee reaches the marked height
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Oct 2024
- Primary completion2 May 2025
- Study completion2 May 2025
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Bragança
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Schneider, Instituto Politécnico de Bragança
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843486
- Sponsor's protocol ID
- 755614
- Acronym
- SB
- Status last verified
- May 2025
- First submitted
- 5 Feb 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Bones: Promoting Bone Health and Quality of Life in Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT06843486
- Acronym / sponsor ID
- SB / 755614
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Womens, Menopause
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Politécnico de BragançaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 25 Feb 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 goal of this clinical trial is to find out whether multicomponent training works to treat osteoporosis in women. It will also find out about the safety of multicomponent training in this specific population. The main questions it aims to answer are:
Does multicomponent training improve bone mineral density in women?
What are the benefits of multicomponent training?
The researchers will compare the intervention group (MTC) with a control group that did not perform any type of intervention, to see if MTC training works in treating bone mineral density in women.
The participants will:
Perform MTC training for 6 months with a frequency of 3 times a week in sessions of 40-60 minutes. While the control group will carry out their daily activities normally and will only attend on the days of the assessments.
Detailed description
The Strong Bones Project is a randomized controlled trial (RCT) investigating the effects of Multicomponent Training (MCT) on bone mineral density (BMD), quality of life, and risk of osteoporosis in women.
The study adopts a hybrid approach combining cross-sectional observational analyses and randomized experimental interventions. Participants will be randomly allocated to an intervention group and a control group, allowing comparison of the impacts of MCT.
The interventions include a structured physical exercise program, with three distinct approaches:
- In-Person Supervised Multicomponent Training (MCT In-Person)
- Control Group (No active intervention, only clinical monitoring)
Training sessions will include aerobic, resistance, balance, and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention.
Data collection will include:
- Sociodemographic data
- Bone mineral density (BMD), assessed by DXA (Dual-Energy X-ray Absorptiometry)
- Functional fitness tests (e.g. handgrip strength test)
Participants will be followed for 6 months, with monthly assessments to monitor the progression of clinical variables.
Expected results include improved bone density, reduced risk of fractures, and improved quality of life.
The findings will be disseminated through scientific publications in peer-reviewed journals and presentations at international conferences on bone health and physical exercise.
This study seeks to contribute to the formulation of personalized physical exercise guidelines for the prevention of osteoporosis, especially in premenopausal women and men at intermediate risk of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The group will not receive any type of intervention |
| Multicomponent Exercise | Experimental | Other: Multicomponent ExerciseParticipants receive an intervention (a multi-component exercise program). |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range: Women over 65 years of age. Clinical diagnosis:
- Previous diagnosis of osteoporosis confirmed by DXA (T-score between -1.0 and -2.5 for osteopenia and ≤ -2.5 for osteoporosis).
- Ability to exercise: Medical clearance to participate in the exercise program. and ability to perform moderate-impact physical activities and muscular endurance.
- Level of physical activity: Sedentary women or women with low to moderate levels of physical activity, without regular practice of specific exercises for bone health in the last 6 months.
- Agreement to the study: Signing of the Free and Informed Consent Form (FICF) and availability to participate in the training program for 6 months.
Key exclusion criteria (6 listed)
- Advanced clinical diagnosis: T-score below -3.0 (severe osteoporosis with high risk of fractures); History of severe osteoporotic fracture in the last 6 months.
- Associated diseases or conditions: Uncontrolled metabolic or endocrine diseases that affect bone metabolism (e.g., hyperparathyroidism, Cushing's syndrome, decompensated diabetes); Active chronic inflammatory diseases (e.g., advanced rheumatoid arthritis, systemic lupus erythematosus); Severe chronic renal failure (stages 4 or 5).
- Use of specific medications in the last 12 months: Bisphosphonates, denosumab, teriparatide or strontium ranelate; High-dose glucocorticoids (>5 mg/day for more than 3 months); Recent hormone therapy for osteoporosis.
- Orthopedic or neuromuscular conditions: Severe functional limitation that prevents the performance of physical exercises (e.g., severe osteoarthritis, advanced joint instability, neurological sequelae of stroke); Orthopedic surgery in the last 6 months or indication for elective surgery for the spine or lower limbs.
- Factors that limit adherence to the study: Difficulty in moving that prevents participation in in-person training (for the in-person MCT group); Lack of availability to attend sessions or follow the study protocol; History of low adherence to previous health-related interventions.
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 |
|---|---|---|
| Multicomponent ExerciseTraining sessions will include aerobic, resistance, balance and flexibility exercises, following the American College of Sports Medicine (ACSM) guidelines for osteoporosis prevention. | Other | Multicomponent Exercise |
Primary outcome
Bone mineral density (BMD)
Time frame: From enrollment to the end of treatment at 6 months
Bone mineral density (BMD), measured in g/cm², assesses regions such as the lumbar spine, proximal femur, and total body. It is used to diagnose and monitor osteopenia and osteoporosis based on WHO criteria. The T-score, expressed in standard deviations (SD), compares the patient's BMD to that of a young, healthy population, classifying osteopenia (T-score -1.0 to -2.5 SD) and osteoporosis (T-score ≤ -2.5 SD). The Z-score compares BMD to age- and sex-matched averages, aiding in identifying secondary causes of osteoporosis. Dual-energy X-ray absorptiometry (DXA) is the standard method for measuring BMD. Additionally, DXA provides body composition analysis, offering data on bone mass (grams), lean mass (grams/kilograms), and body fat percentage (%). These parameters enable a comprehensive assessment of musculoskeletal health and nutritional status.
6 secondary outcomes
Lower Limb Strength
Time frame: From enrollment to the end of treatment at 6 months
Upper Limb Strength
Time frame: From enrollment to the end of treatment at 6 months
Lower Limb Flexibility
Time frame: From enrollment to the end of treatment at 6 months
Upper Limb Flexibility
Time frame: From enrollment to the end of treatment at 6 months
Agility/Balance
Time frame: From enrollment to the end of treatment at 6 months
Aerobic Endurance
Time frame: From enrollment to the end of treatment at 6 months
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 6 May 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Multicomponent Exercise in people with Osteoporosis, run by Instituto Politécnico de Bragança at 1 site in Portugal.
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 5 inclusion and 6 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 6 May 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 Portugal. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone mineral density (BMD) (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.