Clinical trial NCT01130428: Mechanical Bone Stimulation and Adenosine 5'-Triphosphate (ATP) Release in Humans
Official title: Pilot Study on the Effect of Mechanical Stimulation of Bone on ATP Release in Humans in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoporosis
Keywords: Mechanical stimulation
Vibration platform
Bone metabolism
ATP release
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Research Center for Ageing and Osteoporosis, Copenhagen University Hospital, Copenhagen, Denmark.
name: University of Sheffield
First posted: 2010-05-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change in systemic ATP levels in response to mechanical stimulation
timeFrame: Pre-post treatment comparison
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center, Department of Epidemiology
name: PC Dagnelie, PhD
role: STUDY_CHAIR
affiliation: Maastricht University Medical Center, Department of Epidemiology
name: MJL Bours, PhD
role: PRINCIPAL_INVESTIGATOR
References: