Age-Related OsteoporosisNCT05164679
Training in a Local Community Aimed Upon Musculoskeletal Health Promotion for Postmenopausal Women
A study testing multimodal training (MMT) in people with Age-Related Osteoporosis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
To minimize fracture risk, diverse and varied training of high intensity (multimodal training) is recommended to increase bone strength. However, the effectiveness of different training programmes performed in community settings remain uncertain. Read more about this study
- Who is it for?
- Ages Up to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Age-Related Osteoporosis
- What is being tested?
- multimodal training (MMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2019to 9 Jul 2019
- 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 Up to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- past menopause
- non-smoking
- BMI <30 kg/m2
Who cannot join
- T-score < -3 SD in the lumbar spine or hip
- Z-score > 1.5 SD)
- use of hormone therapy, medical treatment or supplements that affect bone metabolism
- previous or current medical condition affecting bone health
- engagement in regular and systemic weight-bearing training or strength training during the preceding two years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Nutrition, Exercise and Sports
Copenhagen, 2200
About this study
Official title: A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion With Special Emphasis on Musculoskeletal Health Effects
To minimize fracture risk, diverse and varied training of high intensity (multimodal training) is recommended to increase bone strength. However, the effectiveness of different training programmes performed in community settings remain uncertain. The present study aimed to evaluate the feasibility and the effectiveness of 19-week of multimodal training in a local community center in Copenhagen, Denmark. The health promotion initiative had special emphasis on musculoskeletal health in postmenopausal women.
Read the detailed description
A local community center was offering supervised multimodal training (MMT) to postmenopausal, healthy women twice weekly, and the aim of the present study was to evaluate the feasibility and the musculoskeletal health promoting effects of the training. The evaluation study lasted for 19 weeks, and the average attendance rate of MMT participants had to be > 1 hour weekly. The primary outcomes were bone mineral density (BMD) assessed by Dual-Energy X-ray Absorptiometry (DXA) scanning and the fasted plasma concentration of bone turnover markers (BTM): N-terminal propeptide of type I procollagen (P1NP) , C-terminal telopeptide of type I collagen (CTX), Osteocalcin), while secondary outcomes were body composition variables, dynamic postural balance and functional muscle strength. To test within- and between-group differences in the pre and post outcomes the training group (MMT) was compared with a sedentary control group (CON).
Every participant was fully informed before giving her written informed consent to the procedures and potential discomfort associated with the study. The study was conducted in accordance with the Declaration of Helsinki and approved by the local ethics committee of the Capital Region of Denmark, H-18044190.
- Conditions
- Age-Related Osteoporosis
- Being tested
- multimodal training (MMT)
- Keywords
- Bone mineral density, bone turnover marker, high-impact, odd-impact, resistance exercise, menopause, health promotion
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal training (MMT)Behavioural
Also called Sedentary control group (CON)
Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks
| Study group | Role | What they receive |
|---|---|---|
| MMT | Experimental | Intervention group performing multimodal training (MMT) 1-2 hours weekly Receives: Behavioral: multimodal training (MMT) |
| CON | No intervention | Sedentary control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body and regional BMD
bone mineral density (g/cm2)
Measured: 19 weeks
Osteocalcin
Concentration of Osteocalcin in plasma in fasted state (µg/l)
Measured: 3 weeks and 19 weeks
P1NP
Concentration of P1NP in plasma in fasted state (µg/l)
Measured: 3 weeks and 19 weeks
CTX
Concentration of CTX in plasma in fasted state (ng/l)
Measured: 3 weeks and 19 weeks
Secondary outcomes (9)
Body fat percentage
Body fat percentage (%)
Measured: 19 weeks
Visceral adipose tissue (VAT)
Volume (m3)
Measured: 19 weeks
Body weight
kg
Measured: 19 weeks
BMI
kg/m2
Measured: 19 weeks
Total fat mass
kg
Measured: 19 weeks
Total lean body mass (LBM)
kg
Measured: 19 weeks
Whole-body bone mineral content (BMC)
g
Measured: 19 weeks
dynamic balance
time to fulfill a four-square-balance test (sec)
Measured: 19 weeks
dynamic muscle strength
Jump-and-reach-test (cm)
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start4 Jan 2019
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
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 Age-Related OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy, sedentary postmenopausal women aged below 70 years were eligible to participate in the present study. Inclusion criteria were: * non-smoker * body mass index (BMI) \<30 kg/m2. Exclusion criteria were: * T-score \< -3 SD in the lumbar spine or hip * high BMD in relation to age (Z-score \> 1.5 SD) * use of hormone therapy, medical treatment, or supplements that affect bone metabolism * previous or current medical condition affecting bone health * engagement in regular and systematic weight-bearing training or strength training during the preceding two years. Initially, twenty women were recruited to the training via an online advertisement and a local newspaper, but only 19 showed up for pre-testing. After a medical examination, one participant was excluded due to low BMD (T-score \< -3 SD), and two were excluded due to high BMI (≥30 kg/m2).
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewa Wulff Helge, University of Copenhagen
- Investigators
- Eva W Helge, Ph.D., Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164679
- Sponsor's protocol ID
- Knoglestaerk
- Status last verified
- Dec 2021
- First submitted
- 4 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prawiradilaga RS, Bendtsen M, Esrup S, Jorgensen NR, Yulianto FA, Helge EW. Feasibility Study of Community-Based Training for Musculoskeletal Health Promotion. F1000Res. 2024 Sep 4;11:51. doi: 10.12688/f1000research.73698.3. eCollection 2022.
PubMed 39263388
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion With Special Emphasis on Musculoskeletal Health Effects
- ClinicalTrials.gov ID
- NCT05164679
- Acronym / sponsor ID
- Knoglestaerk
- Conditions
- Age-Related Osteoporosis
- Keywords
- Bone mineral density, bone turnover marker, high-impact, odd-impact, resistance exercise, menopause, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 21 Dec 2021 (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.
To minimize fracture risk, diverse and varied training of high intensity (multimodal training) is recommended to increase bone strength. However, the effectiveness of different training programmes performed in community settings remain uncertain. The present study aimed to evaluate the feasibility and the effectiveness of 19-week of multimodal training in a local community center in Copenhagen, Denmark. The health promotion initiative had special emphasis on musculoskeletal health in postmenopausal women.
Detailed description
A local community center was offering supervised multimodal training (MMT) to postmenopausal, healthy women twice weekly, and the aim of the present study was to evaluate the feasibility and the musculoskeletal health promoting effects of the training. The evaluation study lasted for 19 weeks, and the average attendance rate of MMT participants had to be > 1 hour weekly. The primary outcomes were bone mineral density (BMD) assessed by Dual-Energy X-ray Absorptiometry (DXA) scanning and the fasted plasma concentration of bone turnover markers (BTM): N-terminal propeptide of type I procollagen (P1NP) , C-terminal telopeptide of type I collagen (CTX), Osteocalcin), while secondary outcomes were body composition variables, dynamic postural balance and functional muscle strength. To test within- and between-group differences in the pre and post outcomes the training group (MMT) was compared with a sedentary control group (CON).
Every participant was fully informed before giving her written informed consent to the procedures and potential discomfort associated with the study. The study was conducted in accordance with the Declaration of Helsinki and approved by the local ethics committee of the Capital Region of Denmark, H-18044190.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy, sedentary postmenopausal women aged below 70 years were eligible to participate in the present study. Inclusion criteria were: * non-smoker * body mass index (BMI) <30 kg/m2. Exclusion criteria were: * T-score < -3 SD in the lumbar spine or hip * high BMD in relation to age (Z-score > 1.5 SD) * use of hormone therapy, medical treatment, or supplements that affect bone metabolism * previous or current medical condition affecting bone health * engagement in regular and systematic weight-bearing training or strength training during the preceding two years. Initially, twenty women were recruited to the training via an online advertisement and a local newspaper, but only 19 showed up for pre-testing. After a medical examination, one participant was excluded due to low BMD (T-score < -3 SD), and two were excluded due to high BMI (≥30 kg/m2).
| Arm | Type | Receives |
|---|---|---|
| MMT | Experimental | Behavioral: multimodal training (MMT)Intervention group performing multimodal training (MMT) 1-2 hours weekly |
| CON | No intervention | –Sedentary control group |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- past menopause
- non-smoking
- BMI <30 kg/m2
Key exclusion criteria (5 listed)
- T-score < -3 SD in the lumbar spine or hip
- Z-score > 1.5 SD)
- use of hormone therapy, medical treatment or supplements that affect bone metabolism
- previous or current medical condition affecting bone health
- engagement in regular and systemic weight-bearing training or strength training during the preceding two years
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 |
|---|---|---|
| multimodal training (MMT)Also: Sedentary control group (CON)Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks | Behavioural | MMT |
Primary outcome
Whole-body and regional BMD
Time frame: 19 weeks
bone mineral density (g/cm2)
Osteocalcin
Time frame: 3 weeks and 19 weeks
Concentration of Osteocalcin in plasma in fasted state (µg/l)
P1NP
Time frame: 3 weeks and 19 weeks
Concentration of P1NP in plasma in fasted state (µg/l)
CTX
Time frame: 3 weeks and 19 weeks
Concentration of CTX in plasma in fasted state (ng/l)
9 secondary outcomes
Body fat percentage
Time frame: 19 weeks
Visceral adipose tissue (VAT)
Time frame: 19 weeks
Body weight
Time frame: 19 weeks
BMI
Time frame: 19 weeks
Total fat mass
Time frame: 19 weeks
Total lean body mass (LBM)
Time frame: 19 weeks
Whole-body bone mineral content (BMC)
Time frame: 19 weeks
dynamic balance
Time frame: 19 weeks
dynamic muscle strength
Time frame: 19 weeks
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 21 Dec 2021.
- Derived from this study: PubMed 39263388Prawiradilaga RS, Bendtsen M, Esrup S, Jorgensen NR, Yulianto FA, Helge EW. Feasibility Study of Community-Based Training for Musculoskeletal Health Promotion. F1000Res. 2024 Sep 4;11:51. doi: 10.12688/f1000research.73698.3. eCollection 2022.
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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.
Eva W Helge, Ph.D. principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal training (MMT) in people with Age-Related Osteoporosis, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 5 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 21 Dec 2021. 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 Denmark. 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?
Whole-body and regional BMD (time frame: 19 weeks). The study lists 4 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 NCT05164679, 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 21 Dec 2021.