To investigate in vivo whether a measurable increase in systemic ATP levels occurs in response to mechanical stimulation of bone in humans.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As the primary outcome parameter, a change in extracellular ATP concentrations
following the mechanical intervention will be assessed systemically.
Secondary outcome
N.a.
Background summary
Mechanical loading is well-known to have a strong anabolic effect on bone. It
has therefore been proposed that a mechanical intervention could be an
effective non-pharmacological approach to treat bone loss associated with
conditions such as osteopenia and osteoporosis. Data from in vitro experiments
indicate that the purine nucleotide adenosine 5*-triphosphate (ATP) is released
by bone cells and mediates cellular crosstalk via P2 purinergic receptors in
response to mechanical stimulation. ATP release by bone cells may thus be part
of a general mechanism by which mechanical loading ultimately results in
increased bone formation, but this remains to be investigated in humans in
vivo. We hypothesize that a mechanical intervention in humans leads to a rise
in systemic ATP concentrations due to ATP release from bone.
Study objective
To investigate in vivo whether a measurable increase in systemic ATP levels
occurs in response to mechanical stimulation of bone in humans.
Study design
Intervention study with a non-randomized, non-blinded design. All subjects will
participate in one experiment. During the experiment, which will last
approximately 3 hours, subjects will receive a mechanical intervention at a
fixed dose.
Intervention
Subjects will receive a gentle and safe mechanical intervention, which will be
administered by means of a Juvent 1000 Vibration Platform delivering
low-magnitude mechanical stimuli to the forearm. The mechanical stimulation
will be given at a frequency of 90 Hz and amplitude of 10 µm. The mechanical
stimulation will be administered in an intermittent fashion, i.e. three
10-minute periods of stimulation with 10-minute rest periods in between; so 50
minutes in total.
Study burden and risks
Each subject participates in 1 experiment of about 3 hours. During the
experiment, blood samples will be collected on 8 different time points (approx
123 ml in total). Additionally, muscle actvity will be assessed by surface EMG
(elctromyography), for which electrodes will be applied to the skin of the
forearm.
Postbus 616
6200 MD Maastricht
Nederland
Postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
- Healthy human volunteers;
- Age 18-35 years;
- Cannulation of veins in forearm possible.
Exclusion criteria
- Metabolic bone disease (osteoporosis, Paget's disease, hyperparathyroidism, osteomalacia) or any other condition affecting bone metabolism (e.g. corticoid-treated rheumatoid arthritis);
- Recent bone fracture of any kind <= 12 months preceding the study.
- Blood donors.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01130428 |
| CCMO | NL31517.068.10 |