OsteopeniaOsteoAppNCT07897929
Exercise and Fall Prevention for Fracture Reduction
A study testing Guideline-based home exercise training in people with Osteopenia and Osteoporosis, run by Wolfgang Kemmler, PhD at 1 site in Germany.
Trial summary
According to the current guideline of the German Osteology Association (DVO), pharmacological treatment is a cornerstone of osteoporosis-related fracture prevention, effectively increasing bone mineral density and reducing fracture risk. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteopenia, Osteoporosis, High Fall Risk
- What is being tested?
- Guideline-based home exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- community dwelling,
- Identification of osteopenia or osteoporosis via bone density scan (DXA),
- two or more falls during the last 12 months,
- ability to walk unaided without a walking aid,
- Sufficient knowledge of the German language to understand the study information, training instructions and questionnaires (participation is possible provided that adequate support from family members, friends or other suitable translation aids can be guaranteed, and the safe delivery of the training and the collection of valid data are ensured),
- ability to complete the questionnaires independently,
- provision of written informed consent
Who cannot join
- Regular exercise or structured physical training (≥ 2 training sessions per week over the last 12 months)
- Osteoporotic fracture within the last 3 months
- planned orthopaedic or other major surgery during the intervention period
- medical contraindication to physical training or lack of medical clearance to participate
- severe cardiovascular diseases with reduced exercise tolerance (e.g. unstable angina pectoris, decompensated heart failure, uncontrolled cardiac arrhythmias)
- severe neurological diseases with significant impairment of balance or mobility (e.g. advanced Parkinson's disease, stroke with pronounced residual effects)
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- severe visual or hearing impairments that prevent the safe comprehension of training instructions
- cognitive impairments with reduced ability to understand study documents and training instructions (e.g. Mini-Mental State Examination [MMSE] < 24 points or equivalent clinical assessment)
- medication with a potential impact on the study endpoints or the safety of the training programme (e.g. strongly sedative medicines, high-dose psychotropic drugs, systemic corticosteroids with a relevant effect on muscle metabolism or the risk of falls)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Institute of Radiologie, University-Hospital Erlangen
Erlangen, Bavaria, 91052
Wolfgang Kemmler, PhD, ++49 9131 8523999, wolfgang.kemmler@fau.de
Simon von Stengel, PhD, ++49 9131 8523999, simon-von.tengel@fau.de
About this study
Official title: Evaluation of a Guideline-based Home Exercise Programme for the Prevention of Falls and Fractures
According to the current guideline of the German Osteology Association (DVO), pharmacological treatment is a cornerstone of osteoporosis-related fracture prevention, effectively increasing bone mineral density and reducing fracture risk. However, particularly in older adults, falls represent a major independent fracture risk factor. Pharmacological treatment has limited effects on fall-related factors such as muscle strength, balance, mobility, and fall incidence.
Physical exercise, either alone or combined with pharmacological treatment, can address these risk factors and improve fracture prevention. However, specialized osteoporosis exercise programs are not widely available, often face high demand, and require qualified instructors and suitable facilities. Older adults, particularly those with mobility limitations, face additional barriers to participation. Many prefer flexible home-based exercise, whereas fixed schedules and organizational requirements of group programs may compromise adherence and effectiveness.
Read more
Currently available home-based osteoporosis exercise programs do not consistently follow the guideline "Physical Exercise for Fracture Prevention", which targets specific fracture risk determinants according to individual risk profiles. Moreover, these programs lack scientific evaluation.
To address these limitations, our research group developed a home-based exercise program based on our S3 guideline "Physical Exercise for Fracture Prevention". The program differentiates between fracture risk profiles and enables accessible, flexible, and location-independent exercise.
The present study will evaluate the effectiveness of this program in women with reduced bone strength and increased fall risk, a particularly relevant combination of osteoporotic fracture risk factors. Outcomes include surrogate measures of bone strength, fall risk, and mobility under real-world conditions.
Research Question Is a guideline-based, fracture risk-adapted home exercise program effective in improving fracture risk determinants in women with reduced bone strength and increased fall risk when performed independently at home under real-world conditions?
- Conditions
- Osteopenia, Osteoporosis, High Fall Risk
- Being tested
- Guideline-based home exercise training
- Keywords
- Osteoporosis, falls risk, exercise, video guided, intervention
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline-based home exercise trainingOther
Guideline based, video guided home exercise training 3x 15 min for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Guideline-based home training | Experimental | Guideline-based, video-guided hometraining 3x 15 min/week for 16 weeks Receives: Other: Guideline-based home exercise training |
| Inactive control group | No intervention | Waiting control group without any exercise, that maintain their habitual lifestyle during the study period of 16 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of chair rise test performance
Time for the 5 times sit to stand test (5tSTS) in s
Measured: Changes in the 5tStS from the baseline measurement to the 16-week follow-up (FU) assesment
Changes in static balance performance
Balance performance applying the modified balance test based on the Short Physical Performance Battery (SPPB). Score from 0-4 with higher values indicationg better static balance
Measured: Changes in balance performance from the baseline measurement to the 16-week follow-up (FU) assessment.
Secondary outcomes (11)
Changes in the timed up and go test (TUG)
TUG: Time needed to stand up, walk 3 meters, turn, return, and sit down (in s)
Measured: Changes in the TUG test results from the baseline measurement to the 16-week follow-up.
Changes in habitual walking speed
Habitual walking speed over 10 metres, measured using photoelectric sensors (in s)
Measured: Changes in the habitual walking speed from the baseline measurement to the 16-week follow-up.
Changes in maximum strength of the hip- and leg-extensors
Isokinetic maximum strength of the hip- and leg-extensors as determined by an isokinetic leg press (NM)
Measured: Changes in the isokinetic maximum strength of the hip- and leg-extensors from the baseline measurement to the 16-week follow-up.
Change in maximum trunk extensors strength
Maximum isometric strength of the trunk extensors (kg) as determined by a Dr. Wolff BackCheck
Measured: Change in the maximum isometric strength of the trunk extensors from the baseline measurement to the 16-week follow-up.
Changes in fear of falling
Fear of falling as determined by the "Short Falls Efficacy Scale-International" (FES I). 7 Items, Score from 7-28, with higher scores indicating higher concerns of falling
Measured: Change in FES I from the baseline measurement to the 16-week follow-up.
Changes in bone formation biomarkers
Changes in the bone formation marker "Procollagen Type I N-terminal Propeptide" (PINP, ng/ml)) as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Note: Only in women not receiving medication for osteoporosis
Measured: Change in PINP from the baseline measurement to the 16-week follow-up.
Changes in bone resorption biomarkers
Changes in the bone resorption marker "C-terminal telopeptide of type I collagen" (CTX, ng/ml) as determined by Enzyme-Linked Immunosorbent Assay (ELISA).
Note: Only in women not receiving medication for osteoporosis
Measured: Change in CTX from the baseline measurement to the 16-week follow-up.
Changes in fat free mass
Fat free mass (FFM, kg, g) as determined by Bioelectrical Impedance Analysis (BIA)
Measured: Change in FFM from the baseline measurement to the 16-week follow-up.
Changes in total body fat rate
Total body fat rate (%) as determined by Bioelectrical Impedance Analysis (BIA)
Measured: Changes in total body fat rate from the baseline measurement to the 16-week follow-up.
Changes in bone structure (Broadband Ultrasound Attenuation )
Bone structure as determined by Broadband Ultrasound Attenuation (BUA, dB/MHz) at the calcaneus site using an quantitative ultrasound system (QUS)
Measured: Changes in BUA from the baseline measurement to the 16-week follow-up.
Changes in bone structure (Speed of Sound )
Bone structure as determined by Speed of Sound (SOS, m/s) at the calcaneus site using an quantitative ultrasound system (QUS)
Measured: Changes in SOS from the baseline measurement to the 16-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfgang Kemmler, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Erlangen
- Responsible party
- Sponsor-investigator, Wolfgang Kemmler, PhD, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897929
- Sponsor's protocol ID
- OsteoApp1
- Other IDs
- OsteoApp_UKER, OsteoApp_UKER
- Acronym
- OsteoApp
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly, as participants did not provide informed consent for the publication of their anonymized data in a clinical trial registry.
Publications
Kemmler W, Schoene D, Kohl M, Thomasius F, Jakob F, Kerschan-Schindl K, Lange U, Peters S, Stengel SV. Exercise for fracture prevention - evidence and consensus-based practice guideline of the osteology umbrella association (DVO). BMC Endocr Disord. 2026 Feb 16;26(1):98. doi: 10.1186/s12902-026-02194-1.
PubMed 41699562
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Guideline-based Home Exercise Programme for the Prevention of Falls and Fractures
- ClinicalTrials.gov ID
- NCT07897929
- Acronym / sponsor ID
- OsteoApp / OsteoApp1
- Conditions
- Osteopenia, Osteoporosis, High Fall Risk
- Keywords
- Osteoporosis, falls risk, exercise, video guided, intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Wolfgang Kemmler, PhDUniversity, hospital or other
- Collaborators
- University Hospital Erlangen
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
According to the current guideline of the German Osteology Association (DVO), pharmacological treatment is a cornerstone of osteoporosis-related fracture prevention, effectively increasing bone mineral density and reducing fracture risk. However, particularly in older adults, falls represent a major independent fracture risk factor. Pharmacological treatment has limited effects on fall-related factors such as muscle strength, balance, mobility, and fall incidence.
Physical exercise, either alone or combined with pharmacological treatment, can address these risk factors and improve fracture prevention. However, specialized osteoporosis exercise programs are not widely available, often face high demand, and require qualified instructors and suitable facilities. Older adults, particularly those with mobility limitations, face additional barriers to participation. Many prefer flexible home-based exercise, whereas fixed schedules and organizational requirements of group programs may compromise adherence and effectiveness.
Currently available home-based osteoporosis exercise programs do not consistently follow the guideline "Physical Exercise for Fracture Prevention", which targets specific fracture risk determinants according to individual risk profiles. Moreover, these programs lack scientific evaluation.
To address these limitations, our research group developed a home-based exercise program based on our S3 guideline "Physical Exercise for Fracture Prevention". The program differentiates between fracture risk profiles and enables accessible, flexible, and location-independent exercise.
The present study will evaluate the effectiveness of this program in women with reduced bone strength and increased fall risk, a particularly relevant combination of osteoporotic fracture risk factors. Outcomes include surrogate measures of bone strength, fall risk, and mobility under real-world conditions.
Research Question Is a guideline-based, fracture risk-adapted home exercise program effective in improving fracture risk determinants in women with reduced bone strength and increased fall risk when performed independently at home under real-world conditions?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guideline-based home training | Experimental | Other: Guideline-based home exercise trainingGuideline-based, video-guided hometraining 3x 15 min/week for 16 weeks |
| Inactive control group | No intervention | –Waiting control group without any exercise, that maintain their habitual lifestyle during the study period of 16 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- community dwelling,
- Identification of osteopenia or osteoporosis via bone density scan (DXA),
- two or more falls during the last 12 months,
- ability to walk unaided without a walking aid,
- Sufficient knowledge of the German language to understand the study information, training instructions and questionnaires (participation is possible provided that adequate support from family members, friends or other suitable translation aids can be guaranteed, and the safe delivery of the training and the collection of valid data are ensured),
Key exclusion criteria (9 listed)
- Regular exercise or structured physical training (≥ 2 training sessions per week over the last 12 months)
- Osteoporotic fracture within the last 3 months
- planned orthopaedic or other major surgery during the intervention period
- medical contraindication to physical training or lack of medical clearance to participate
- severe cardiovascular diseases with reduced exercise tolerance (e.g. unstable angina pectoris, decompensated heart failure, uncontrolled cardiac arrhythmias)
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 |
|---|---|---|
| Guideline-based home exercise trainingGuideline based, video guided home exercise training 3x 15 min for 16 weeks | Other | Guideline-based home training |
Primary outcome
Changes of chair rise test performance
Time frame: Changes in the 5tStS from the baseline measurement to the 16-week follow-up (FU) assesment
Time for the 5 times sit to stand test (5tSTS) in s
Changes in static balance performance
Time frame: Changes in balance performance from the baseline measurement to the 16-week follow-up (FU) assessment.
Balance performance applying the modified balance test based on the Short Physical Performance Battery (SPPB). Score from 0-4 with higher values indicationg better static balance
11 secondary outcomes
Changes in the timed up and go test (TUG)
Time frame: Changes in the TUG test results from the baseline measurement to the 16-week follow-up.
Changes in habitual walking speed
Time frame: Changes in the habitual walking speed from the baseline measurement to the 16-week follow-up.
Changes in maximum strength of the hip- and leg-extensors
Time frame: Changes in the isokinetic maximum strength of the hip- and leg-extensors from the baseline measurement to the 16-week follow-up.
Change in maximum trunk extensors strength
Time frame: Change in the maximum isometric strength of the trunk extensors from the baseline measurement to the 16-week follow-up.
Changes in fear of falling
Time frame: Change in FES I from the baseline measurement to the 16-week follow-up.
Changes in bone formation biomarkers
Time frame: Change in PINP from the baseline measurement to the 16-week follow-up.
Changes in bone resorption biomarkers
Time frame: Change in CTX from the baseline measurement to the 16-week follow-up.
Changes in fat free mass
Time frame: Change in FFM from the baseline measurement to the 16-week follow-up.
Changes in total body fat rate
Time frame: Changes in total body fat rate from the baseline measurement to the 16-week follow-up.
Changes in bone structure (Broadband Ultrasound Attenuation )
Time frame: Changes in BUA from the baseline measurement to the 16-week follow-up.
Changes in bone structure (Speed of Sound )
Time frame: Changes in SOS from the baseline measurement to the 16-week follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 41699562Kemmler W, Schoene D, Kohl M, Thomasius F, Jakob F, Kerschan-Schindl K, Lange U, Peters S, Stengel SV. Exercise for fracture prevention - evidence and consensus-based practice guideline of the osteology umbrella association (DVO). BMC Endocr Disord. 2026 Feb 16;26(1):98. doi: 10.1186/s12902-026-02194-1.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly, as participants did not provide informed consent for the publication of their anonymized data in a clinical trial registry.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline-based home exercise training in people with Osteopenia and Osteoporosis, run by Wolfgang Kemmler, PhD at 1 site in Germany.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Kemmler, PhD (++49 9131 8523999, wolfgang.kemmler@fau.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of chair rise test performance (time frame: Changes in the 5tStS from the baseline measurement to the 16-week follow-up (FU) assesment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07897929, which also lists 1 linked publication.
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 29 Oct 2026.