Bone ResorptionHEPNCT01576081
The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature
A study testing HEPHAISTOS in people with Bone Resorption, run by DLR German Aerospace Center at 1 site in Germany.
Trial summary
The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- HEPHAISTOS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Jul 2012
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- age: 20-40 years
- BMI: 20-30
- passing the psychological and medical check up.
- signed consent to participate in the study
- faultless certificate of good conduct
Who cannot join
- smoking
- professional athletes
- diabetes
- muscle or joint disease
- trabecular bone density in the distal tibia epiphysis < 160mg/cm3
- increase risk of thrombosis
Show all 24Show fewer
- bone fractures 12 months prior to the study
- metal implants, any material of osteosynthesis
- participation in another clinical intervention study 2 months prior to the study
- bleeding disorder
- anesthetic intolerance
- vascular disease
- epilepsy
- claustrophobia
- herniated disk
- pacemaker
- alcohol or drug abuse
- anti-inflammatory drug intake during the study
- hyperlipidemia
- kidney disease
- hyperhomocysteinaemia
- vitamin d deficit
- chronical back pain
- detained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a 56day Unilateral Muscular Unloading Intervention With a Novel Device That Allows Normal Ambulation While Reducing Muscle Activation Drastically, on Muscles, Bones and Vessels.
The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.
Read the detailed description
The 56day unloading intervention with HEPHAISTOS had the following key objectives:
- Primary objective: Assessment and evaluation of bone adaptation.
- Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
- Third objective: Assessment and evaluation of functional and structural vascular adaptations.
- Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.
- Conditions
- Bone Resorption
- Being tested
- HEPHAISTOS
- Keywords
- bone density, weight bearing, muscle atrophy, vascular degeneration, gravitational loading, muscular unloading
- Medical subject headings
- Bone Resorption, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPHAISTOSDevice
HEPHAISTOS unloading orthotic
| Study group | Role | What they receive |
|---|---|---|
| Unilateral orthotic intervention | Experimental | The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects. Receives: Device: HEPHAISTOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density as measured with pQCT
subjects will be followed for one year, starting from the onset of the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joern Rittweger, Prof. Dr., Study director, DLR German Aerospace CenterTobias Weber, Principal investigator, DLR German Aerospace CenterMichel Ducos, Principal investigator, DLR German Aerospace Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576081
- Sponsor's protocol ID
- DLR
- Acronym
- HEP
- Status last verified
- Aug 2012
- First submitted
- 3 Apr 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weber T, Ducos M, Mulder E, Beijer A, Herrera F, Zange J, Degens H, Bloch W, Rittweger J. The relationship between exercise-induced muscle fatigue, arterial blood flow and muscle perfusion after 56 days local muscle unloading. Clin Physiol Funct Imaging. 2014 May;34(3):218-29. doi: 10.1111/cpf.12087. Epub 2013 Oct 7.
PubMed 24119174Weber T, Ducos M, Mulder E, Herrera F, Bruggemann GP, Bloch W, Rittweger J. The specific role of gravitational accelerations for arterial adaptations. J Appl Physiol (1985). 2013 Feb;114(3):387-93. doi: 10.1152/japplphysiol.01117.2012. Epub 2012 Dec 6.
PubMed 23221961
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 56day Unilateral Muscular Unloading Intervention With a Novel Device That Allows Normal Ambulation While Reducing Muscle Activation Drastically, on Muscles, Bones and Vessels.
- ClinicalTrials.gov ID
- NCT01576081
- Acronym / sponsor ID
- HEP / DLR
- Conditions
- Bone Resorption
- Keywords
- bone density, weight bearing, muscle atrophy, vascular degeneration, gravitational loading, muscular unloading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Apr 2012 (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.
The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.
Detailed description
The 56day unloading intervention with HEPHAISTOS had the following key objectives:
- Primary objective: Assessment and evaluation of bone adaptation.
- Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
- Third objective: Assessment and evaluation of functional and structural vascular adaptations.
- Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral orthotic intervention | Experimental | Device: HEPHAISTOSThe HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male
- age: 20-40 years
- BMI: 20-30
- passing the psychological and medical check up.
- signed consent to participate in the study
Key exclusion criteria (24 listed)
- smoking
- professional athletes
- diabetes
- muscle or joint disease
- trabecular bone density in the distal tibia epiphysis < 160mg/cm3
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 |
|---|---|---|
| HEPHAISTOSHEPHAISTOS unloading orthotic | Device | Unilateral orthotic intervention |
Primary outcome
Bone density as measured with pQCT
Time frame: 1 year
subjects will be followed for one year, starting from the onset of the study
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 16 Aug 2012.
- Derived from this study: PubMed 24119174Weber T, Ducos M, Mulder E, Beijer A, Herrera F, Zange J, Degens H, Bloch W, Rittweger J. The relationship between exercise-induced muscle fatigue, arterial blood flow and muscle perfusion after 56 days local muscle unloading. Clin Physiol Funct Imaging. 2014 May;34(3):218-29. doi: 10.1111/cpf.12087. Epub 2013 Oct 7.
- Derived from this study: PubMed 23221961Weber T, Ducos M, Mulder E, Herrera F, Bruggemann GP, Bloch W, Rittweger J. The specific role of gravitational accelerations for arterial adaptations. J Appl Physiol (1985). 2013 Feb;114(3):387-93. doi: 10.1152/japplphysiol.01117.2012. Epub 2012 Dec 6.
- Webpage German Aerospace Center (DLR), Division Space PhysiologyLink provided by the sponsor.
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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.
Joern Rittweger, Prof. Dr. study director
DLR German Aerospace Center
Tobias Weber principal investigator
DLR German Aerospace Center
Michel Ducos principal investigator
DLR German Aerospace Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEPHAISTOS in people with Bone Resorption, run by DLR German Aerospace Center 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 6 inclusion and 24 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 16 Aug 2012. 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?
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 density as measured with pQCT (time frame: 1 year). 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 NCT01576081, which also lists 2 linked publications.
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 16 Aug 2012.