OsteoporosisNCT02339051
The Effect of Mechanical Loading on Bone Material Strength and Microarchitecture in Postmenopausal Women
A study testing Jumping on one leg in people with Osteoporosis and Postmenopause, run by Mattias Lorentzon.
Trial summary
Osteoporosis is a large public health disease, characterized by low bone mass and micro architectural deterioration of bone tissue, resulting in enhanced bone fragility and consequent increase in fracture risk. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopause
- What is being tested?
- Jumping on one leg
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2015
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 50 and 60 years,
- no history of osteoporosis,
- not undertaken resistance training and/or weight-bearing impact exercise more than once a week in the past three months,
- be able and willing to perform the intervention program (one leg jumping), and
- be reachable via telephone once weekly throughout the study
Who cannot join
- current smoking,
- current or prior (past 6 months) use of hormone replacement therapy,
- having sustained a low trauma fragility fracture in the past 6 months,
- any medical condition (e.g. type 1 diabetes,
- chronic kidney failure or liver disease, cancer) or
- use of medication known to influence bone metabolism or fracture risk (e.g. glucocorticoids, thiazide diuretics, anticonvulsants, bisphosphonates), or
- initiating calcium or vitamin D supplementation in the preceding 6 months
About this study
Osteoporosis is a large public health disease, characterized by low bone mass and micro architectural deterioration of bone tissue, resulting in enhanced bone fragility and consequent increase in fracture risk. Osteoporosis is present when bone mineral density (BMD) or content (BMC), measured by dual-energy X-ray absorptiometry (DXA), is more than 2.5 SDs below the mean value of the young adult. BMD measured by DXA is a surrogate measure of bone strength and is the primary determinant of fracture risk in both men and women. However, the majority of fragility fractures occur in women and in individuals who do not have osteoporosis according to these standards, indicating that BMD is just one among several indicators of bone health and that assessment of fracture risk should also rely on other bone properties. Newer imaging methods, such as quantitative computerized tomography (QCT), can complement information from DXA-measurements due to its ability to assess volumetric BMD and bone geometry and to differentiate between cortical and trabecular bone compartments. Bones are composite materials made predominantly of living cells, extracellular matrix, water and lipids. This composite nature of the bone material enables it to absorb stresses by elastic deformation and to endure high loads before fracturing. A new in vivo measurements of bone material strength can be used to evaluate bone mechanical properties and thereby the fracture risk. It is well established that the skeleton benefits, in terms of increased density, from regular physical activity. However, changes in BMD are still the main surrogate for assessing improvements in exercise-induced bone health despite the experimental findings as well as findings in humans showing that improvements in mechanical bone properties are independent of changes in BMD. These improvements in mechanical bone properties may be due to changes in bone shape or matrix composition. It could then be argued that a decrease in BMD is only one of the possible manifestations of osteoporosis and that bone strength or fragility is multifactorial. The objective for this study is to investigate the role of mechanical loading on bone material strength and bone microarchitecture in middle-aged women. The overall hypothesis is that mechanical loading is a regulator of bone material strength and microarchitecture in middle-aged women. This is an intervention study where the participants will act as their own controls. The investigators intend to include 40 postmenopausal and healthy women 50-60 years of age in the study. Advertisements in local papers and at the hospital will be used to come into contact with suitable study subjects. The women will be asked to perform an intervention program, including jumping on one leg every day during a 3-month period according to a protocol with a gradually increasing load/number of jumps. The women have to choose one of their legs as intervention-leg and stick to the chosen leg throughout the study. The leg without intervention will be used as a control. Both bone material strength (BMS) and bone microarchitecture will be measured before and after intervention in both legs (tibia). The operators measuring BMS (OsteoProbe®) and bone microarchitecture (high resolution pQCT) will be blinded concerning each participant's choice of leg for intervention. In addition, subjects will be asked to register daily physical activity in a structured diary. The primary outcome measure will be changes in bone material strength (BMS) in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention. Participants will attend two clinic visits, at baseline and after 3 months when the intervention period is completed. The secondary outcome measures will be changes in total volumetric density, cortical volumetric density, cortical cross sectional area and trabecular bone volume fraction in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention.
- Conditions
- Osteoporosis, Postmenopause
- Being tested
- Jumping on one leg
- Keywords
- Basic Science
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jumping on one legBehavioural
| Study group | Role | What they receive |
|---|---|---|
| One leg jumping | Experimental | Study subjects will jump on one leg on repeated occasions (incremental daily repetitions) for a period of three months. The same leg will be used for jumping throughout the study. The other leg will serve as control. Receives: Behavioral: Jumping on one leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone material strength in the tibia (measured using OsteoProbe®)
Bone material strength measured using OsteoProbe®
Measured: Three months
Secondary outcomes (4)
Changes in total volumetric density in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Measured using high-resolution pQCT device (HR-pQCT) (XtremeCT, Scanco Medical AG, Switzerland)
Measured: Three months
Changes in cortical volumetric density in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Measured using high-resolution pQCT device (HR-pQCT) (XtremeCT, Scanco Medical AG, Switzerland)
Measured: Three months
Changes in cortical cross sectional area in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Measured using high-resolution pQCT device (HR-pQCT) (XtremeCT, Scanco Medical AG, Switzerland)
Measured: Three months
Changes in trabecular bone volume fraction in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Measured using high-resolution pQCT device (HR-pQCT) (XtremeCT, Scanco Medical AG, Switzerland)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mattias Lorentzon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mattias Lorentzon, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339051
- Sponsor's protocol ID
- Dnr 563-14
- Status last verified
- Jul 2016
- First submitted
- 12 Jan 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Loading on Bone Material Strength and Microarchitecture in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02339051
- Acronym / sponsor ID
- Dnr 563-14
- Conditions
- Osteoporosis, Postmenopause
- Keywords
- Basic Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mattias LorentzonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jan 2015 (estimated)
- 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.
Osteoporosis is a large public health disease, characterized by low bone mass and micro architectural deterioration of bone tissue, resulting in enhanced bone fragility and consequent increase in fracture risk. Osteoporosis is present when bone mineral density (BMD) or content (BMC), measured by dual-energy X-ray absorptiometry (DXA), is more than 2.5 SDs below the mean value of the young adult. BMD measured by DXA is a surrogate measure of bone strength and is the primary determinant of fracture risk in both men and women. However, the majority of fragility fractures occur in women and in individuals who do not have osteoporosis according to these standards, indicating that BMD is just one among several indicators of bone health and that assessment of fracture risk should also rely on other bone properties. Newer imaging methods, such as quantitative computerized tomography (QCT), can complement information from DXA-measurements due to its ability to assess volumetric BMD and bone geometry and to differentiate between cortical and trabecular bone compartments. Bones are composite materials made predominantly of living cells, extracellular matrix, water and lipids. This composite nature of the bone material enables it to absorb stresses by elastic deformation and to endure high loads before fracturing. A new in vivo measurements of bone material strength can be used to evaluate bone mechanical properties and thereby the fracture risk. It is well established that the skeleton benefits, in terms of increased density, from regular physical activity. However, changes in BMD are still the main surrogate for assessing improvements in exercise-induced bone health despite the experimental findings as well as findings in humans showing that improvements in mechanical bone properties are independent of changes in BMD. These improvements in mechanical bone properties may be due to changes in bone shape or matrix composition. It could then be argued that a decrease in BMD is only one of the possible manifestations of osteoporosis and that bone strength or fragility is multifactorial. The objective for this study is to investigate the role of mechanical loading on bone material strength and bone microarchitecture in middle-aged women. The overall hypothesis is that mechanical loading is a regulator of bone material strength and microarchitecture in middle-aged women. This is an intervention study where the participants will act as their own controls. The investigators intend to include 40 postmenopausal and healthy women 50-60 years of age in the study. Advertisements in local papers and at the hospital will be used to come into contact with suitable study subjects. The women will be asked to perform an intervention program, including jumping on one leg every day during a 3-month period according to a protocol with a gradually increasing load/number of jumps. The women have to choose one of their legs as intervention-leg and stick to the chosen leg throughout the study. The leg without intervention will be used as a control. Both bone material strength (BMS) and bone microarchitecture will be measured before and after intervention in both legs (tibia). The operators measuring BMS (OsteoProbe®) and bone microarchitecture (high resolution pQCT) will be blinded concerning each participant's choice of leg for intervention. In addition, subjects will be asked to register daily physical activity in a structured diary. The primary outcome measure will be changes in bone material strength (BMS) in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention. Participants will attend two clinic visits, at baseline and after 3 months when the intervention period is completed. The secondary outcome measures will be changes in total volumetric density, cortical volumetric density, cortical cross sectional area and trabecular bone volume fraction in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One leg jumping | Experimental | Behavioral: Jumping on one legStudy subjects will jump on one leg on repeated occasions (incremental daily repetitions) for a period of three months. The same leg will be used for jumping throughout the study. The other leg will serve as control. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged between 50 and 60 years,
- no history of osteoporosis,
- not undertaken resistance training and/or weight-bearing impact exercise more than once a week in the past three months,
- be able and willing to perform the intervention program (one leg jumping), and
- be reachable via telephone once weekly throughout the study
Key exclusion criteria (7 listed)
- current smoking,
- current or prior (past 6 months) use of hormone replacement therapy,
- having sustained a low trauma fragility fracture in the past 6 months,
- any medical condition (e.g. type 1 diabetes,
- chronic kidney failure or liver disease, cancer) or
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 |
|---|---|---|
| Jumping on one leg | Behavioural | One leg jumping |
Primary outcome
Changes in bone material strength in the tibia (measured using OsteoProbe®)
Time frame: Three months
Bone material strength measured using OsteoProbe®
4 secondary outcomes
Changes in total volumetric density in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Time frame: Three months
Changes in cortical volumetric density in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Time frame: Three months
Changes in cortical cross sectional area in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Time frame: Three months
Changes in trabecular bone volume fraction in the tibia (Measured using high-resolution pQCT device (HR-pQCT)
Time frame: Three 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 11 Jul 2016.
Related trials for Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
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.
Questions about this trial
What is this clinical trial studying?
A study testing Jumping on one leg in people with Osteoporosis and Postmenopause, run by Mattias Lorentzon.
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 7 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in bone material strength in the tibia (measured using OsteoProbe®) (time frame: Three 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 11 Jul 2016.