OsteoporosisNCT05721014
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
A study testing OsteoStrong and Individually Adapted and Combined Physical Training in people with Osteoporosis and Osteopenia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this clinical trial is to investigate the effect of the OsteoStrong training method and the Individually Adapted and Combined Training on the bone health of older women with high fracture risk. Additionally, the aim is also to explore the participants' experiences of each training method. Read more about this study
- Who is it for?
- Ages 65 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia, Bone Density, Low
- What is being tested?
- OsteoStrong and Individually Adapted and Combined Physical Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2021to 14 Feb 2024
- Phase
- Interventional
- 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 65 to 79 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Woman, 65-79 years old.
- Vaccinated against Covid-19.
- Be able to participate in nine months of training.
- Untreated with Osteoporosis-medications, or have an ongoing treatment since at least one year back.
Who cannot join
- Ongoing treatment with Osteoporosis-medications with an onset within a year, or a previous treatment which was terminated within the last five years.
- Ongoing treatment with Osteoporosis-medications that has been delayed for more than eight months for Denosumab, or more than 18 months for bisphosphonates.
- Vertebral fracture, that have been diagnosed within three months.
- Vertebral fracture or hip fracture, that have not previously been treated with Osteoporosis-medications or been assessed by a physician.
- Bilateral hip replacements.
- Symptomatic disc herniation, inguinal herniation or umbilical herniation.
Show all 11Show fewer
- Untreated hypertension.
- Other diseases that can affect the results and participation in the study: malignant diseases, muscle dystrophy, secondary osteoporosis, or other conditions that would hinder study participation.
- Ongoing treatment with oral cortisone pills (≥ 5 mg Prednisolone).
- Conditions that hinders the conduction of impact microindentation with OsteoProbe: large edema, skin infection, allergy towards local anaesthetics.
- Ongoing or previous training (within the last year) at OsteoStrong.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care
Huddinge, Stockholm County, 141 52
About this study
Official title: Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial
The aim of this clinical trial is to investigate the effect of the OsteoStrong training method and the Individually Adapted and Combined Training on the bone health of older women with high fracture risk. Additionally, the aim is also to explore the participants' experiences of each training method.
Participants will be randomised to either treatment arm A (OsteoStrong) or treatment arm B (Individually Adapted and Combined Training). Participants in both groups will train for nine months. Treatment arm A will train individually once a week and treatment arm B will train in a group twice a week. Both groups will have a training instructor who will supervise and give training instructions.
Researchers will compare the groups to see the effects of the training methods on the participants' bone health among other outcome measures. The participants will be tested at baseline and post-intervention (9 months later).
- Conditions
- Osteoporosis, Osteopenia, Bone Density, Low, Bone Loss
- Being tested
- OsteoStrong, Individually Adapted and Combined Physical Training
- Keywords
- osteoporosis, osteopenia, bone mineral density, bone density, physical activity, strength training, isometric training
- 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.
OsteoStrongOther
This training method is an isometric high-impact loading in four different training machines (Spectrum) and balance training on a vibration plate. The four machines are "chest press", "leg press", "pull-down" and "deadlift". The participants press and/or pull isometrically for around 10-15 seconds 1-3 times on every machine.
The training session takes around 20 minutes and is performed individually by the participants with the help of a training instructor.
Individually Adapted and Combined Physical TrainingOther
This training method is based on the current recommendations on physical activity for people with osteoporosis.
The training is divided into two training sessions:
Circuit training with ten stations with different exercises for the whole body (strength, balance, endurance, weight-bearing). The participants spend 40 seconds on each station. This is repeated during 40 minutes. The training session starts with a joint warm-up and ends with a cool-down.
Strength training with machines for the whole body with the intensity of up to 70-80 % of one repetition max (1RM). The training session starts with a joint warm-up and and a voluntary individual cool-down.
The training session takes around 60 minutes and is performed in a group with the help of a training instructor. The participants also have the option to do a home based exercise programme that they could do in a few cases when they were unable to attend the physical group training.
| Study group | Role | What they receive |
|---|---|---|
| OsteoStrong | Experimental | Training following the OsteoStrong-method. Receives: Other: OsteoStrong |
| Individually Adapted and Combined Physical Training | Active comparator | Training based on current recommendations on exercise for people with osteoporosis. Receives: Other: Individually Adapted and Combined Physical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Material Strength Index (BMSI)
Bone Material Strength Index measured with impact microindentation using OsteoProbe
Measured: Change from baseline at 9 months
Secondary outcomes (23)
Bone Mineral Density (BMD)
Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
Measured: Change from baseline at 9 months
Procollagen Type 1 N-terminal propeptide (S-PINP)
Bone biomarker
Measured: Change from baseline at 3 and 9 months
Serum C-telopeptide cross-link type 1 collagen (S-CTX)
Bone biomarker
Measured: Change from baseline at 3 and 9 months
Sclerostin
Bone biomarker
Measured: Change from baseline at 3 and 9 months
Bone alkaline phosphatase (S-BALP)
Bone biomarker
Measured: Change from baseline at 3 and 9 months
Self-rated health questionnaire (SF-36)
A questionnaire with multiple choice questions about general health
Measured: Change from baseline at 9 months
Falls Efficacy Scale (FES)
A questionnaire about self-efficacy and fear of falling, 1-10, where 0 equals "not sure at all" and 10 equals "completely sure". Higher scores equals better outcome.
Measured: Change from baseline at 9 months
Socialstyrelsens questionnaire for lifestyle habits
A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking
Measured: Change from baseline at 9 months
Numerical Rating Scale (NRS)
A pain rating scale from 0-10, where 0 equals "no pain" and 10 equals "maximum/worst possible pain imaginable". Higher scores equals worse outcome.
Measured: Change from baseline at 3 and 9 months
Back extension strength
Measuring back extension strength with Digimax
Measured: Change from baseline at 9 months
Grip strength
Measuring grip strength with hand dynamometer (JAMAR)
Measured: Change from baseline at 9 months
Chair stand test
5 seconds, 30 seconds and time for making 50 chair stands
Measured: Change from baseline at 9 months
Back extension endurance
Measuring back extension endurance with Sörensen's test
Measured: Change from baseline at 9 months
Static sit-up
Sitting with the upper body in 45 degrees
Measured: Change from baseline at 9 months
Lung capacity
Lung capacity measured with dynamic spirometry (Welch Allyn)
Measured: Change from baseline at 9 months
One leg standing (eyes open)
Balance test
Measured: Change from baseline at 9 months
One leg standing (eyes closed)
Balance test
Measured: Change from baseline at 9 months
Two leg standing on a straight line (eyes open)
Balance test
Measured: Change from baseline at 9 months
Two leg standing on a straight line (eyes closed)
Balance test
Measured: Change from baseline at 9 months
Walking forward on a straight line
Balance test
Measured: Change from baseline at 9 months
Walking backwards between to lines
Balance test
Measured: Change from baseline at 9 months
BtrackS
Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed.
Measured: Change from baseline at 9 months
Accelerometry
Accelerometers worn around the waist to measure physical activity levels for up to nine days.
Measured: Change from baseline at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start4 Oct 2021
- Primary completion12 Jul 2023
- Study completion14 Feb 2024
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, The Swedish School of Sport and Health Sciences, Linkoeping University
- Responsible party
- Principal investigator, Helena Salminen, Karolinska Institutet
- Investigators
- Helena Salminen, Ass. prof., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721014
- Sponsor's protocol ID
- 2020-04359 Osteostrong
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05721014
- Acronym / sponsor ID
- 2020-04359 Osteostrong
- Conditions
- Osteoporosis, Osteopenia, Bone Density, Low, Bone Loss
- Keywords
- osteoporosis, osteopenia, bone mineral density, bone density, physical activity, strength training, isometric training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, The Swedish School of Sport and Health Sciences, Linkoeping University
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 9 Feb 2023 (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 aim of this clinical trial is to investigate the effect of the OsteoStrong training method and the Individually Adapted and Combined Training on the bone health of older women with high fracture risk. Additionally, the aim is also to explore the participants' experiences of each training method.
Participants will be randomised to either treatment arm A (OsteoStrong) or treatment arm B (Individually Adapted and Combined Training). Participants in both groups will train for nine months. Treatment arm A will train individually once a week and treatment arm B will train in a group twice a week. Both groups will have a training instructor who will supervise and give training instructions.
Researchers will compare the groups to see the effects of the training methods on the participants' bone health among other outcome measures. The participants will be tested at baseline and post-intervention (9 months later).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsteoStrong | Experimental | Other: OsteoStrongTraining following the OsteoStrong-method. |
| Individually Adapted and Combined Physical Training | Active comparator | Other: Individually Adapted and Combined Physical TrainingTraining based on current recommendations on exercise for people with osteoporosis. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Woman, 65-79 years old.
- Vaccinated against Covid-19.
- Be able to participate in nine months of training.
- Untreated with Osteoporosis-medications, or have an ongoing treatment since at least one year back.
Key exclusion criteria (11 listed)
- Ongoing treatment with Osteoporosis-medications with an onset within a year, or a previous treatment which was terminated within the last five years.
- Ongoing treatment with Osteoporosis-medications that has been delayed for more than eight months for Denosumab, or more than 18 months for bisphosphonates.
- Vertebral fracture, that have been diagnosed within three months.
- Vertebral fracture or hip fracture, that have not previously been treated with Osteoporosis-medications or been assessed by a physician.
- Bilateral hip replacements.
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 |
|---|---|---|
| OsteoStrongThis training method is an isometric high-impact loading in four different training machines (Spectrum) and balance training on a vibration plate. The four machines are "chest press", "leg press", "pull-down" and "deadlift". The participants press and/or pull isometrically for around 10-15 seconds 1-3 times on every machine. The training session takes around 20 minutes and is performed individually by the participants with the help of a training instructor. | Other | OsteoStrong |
| Individually Adapted and Combined Physical TrainingThis training method is based on the current recommendations on physical activity for people with osteoporosis. The training is divided into two training sessions: Circuit training with ten stations with different exercises for the whole body (strength, balance, endurance, weight-bearing). The participants spend 40 seconds on each station. This is repeated during 40 minutes. The training session starts with a joint warm-up and ends with a cool-down. Strength training with machines for the whole body with the intensity of up to 70-80 % of one repetition max (1RM). The training session starts with a joint warm-up and and a voluntary individual cool-down. The training session takes around 60 minutes and is performed in a group with the help of a training instructor. The participants also have the option to do a home based exercise programme that they could do in a few cases when they were unable to attend the physical group training. | Other | Individually Adapted and Combined Physical Training |
Primary outcome
Bone Material Strength Index (BMSI)
Time frame: Change from baseline at 9 months
Bone Material Strength Index measured with impact microindentation using OsteoProbe
23 secondary outcomes
Bone Mineral Density (BMD)
Time frame: Change from baseline at 9 months
Procollagen Type 1 N-terminal propeptide (S-PINP)
Time frame: Change from baseline at 3 and 9 months
Serum C-telopeptide cross-link type 1 collagen (S-CTX)
Time frame: Change from baseline at 3 and 9 months
Sclerostin
Time frame: Change from baseline at 3 and 9 months
Bone alkaline phosphatase (S-BALP)
Time frame: Change from baseline at 3 and 9 months
Self-rated health questionnaire (SF-36)
Time frame: Change from baseline at 9 months
Falls Efficacy Scale (FES)
Time frame: Change from baseline at 9 months
Socialstyrelsens questionnaire for lifestyle habits
Time frame: Change from baseline at 9 months
Numerical Rating Scale (NRS)
Time frame: Change from baseline at 3 and 9 months
Back extension strength
Time frame: Change from baseline at 9 months
Grip strength
Time frame: Change from baseline at 9 months
Chair stand test
Time frame: Change from baseline at 9 months
Back extension endurance
Time frame: Change from baseline at 9 months
Static sit-up
Time frame: Change from baseline at 9 months
Lung capacity
Time frame: Change from baseline at 9 months
One leg standing (eyes open)
Time frame: Change from baseline at 9 months
One leg standing (eyes closed)
Time frame: Change from baseline at 9 months
Two leg standing on a straight line (eyes open)
Time frame: Change from baseline at 9 months
Two leg standing on a straight line (eyes closed)
Time frame: Change from baseline at 9 months
Walking forward on a straight line
Time frame: Change from baseline at 9 months
Walking backwards between to lines
Time frame: Change from baseline at 9 months
BtrackS
Time frame: Change from baseline at 9 months
Accelerometry
Time frame: Change from baseline at 9 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 10 Apr 2024.
- The website for the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
Helena Salminen, Ass. prof. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsteoStrong and Individually Adapted and Combined Physical Training in people with Osteoporosis and Osteopenia, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 11 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 10 Apr 2024. 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 Sweden. 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.
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 Material Strength Index (BMSI) (time frame: Change from baseline at 9 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 10 Apr 2024.