Pilot Study on the Effect of Mechanical Stimulation of Bone on ATP Release in Humans in Vivo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in systemic ATP levels in response to mechanical stimulation
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
Rationale: 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. The investigators hypothesize that a mechanical intervention in humans leads to a rise in systemic ATP concentrations due to ATP release from bone.
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 a single experiment, lasting approximately 3 hours, during which the subjects will receive a mechanical intervention at a fixed dose.
Study population: Maximally 10 healthy human volunteers (18-35 y). 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 (i.e. vibrations) to the forearm. The mechanical stimulation will be administered at a frequency of 90 Hz and amplitude of 10 µm in an intermittent fashion, i.e. three 10-minute periods of stimulation with 10-minute rest periods in between.
Main outcome parameters: As the primary outcome parameter, a change in extracellular ATP concentrations as a result of the mechanical intervention will be assessed systemically.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy human volunteers;
- •Age 18-35 years;
- •Cannulation of veins in forearm possible;
- •Written informed consent.
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.
Outcomes
Primary Outcomes
Change in systemic ATP levels in response to mechanical stimulation
Time Frame: Pre-post treatment comparison
As the primary outcome parameter, ATP release from bone after a mechanical intervention will be investigated in humans in vivo by assessing a change in systemic concentrations of ATP and its metabolites in response to mechanical stimulation as an objective outcome measure. A change in levels of ATP (or its metabolites) is defined as the average of three concentrations after the intervention minus the average of three concentrations before the intervention (i.e. baseline).