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Clinical Trials/NCT01130428
NCT01130428
Completed
Phase 1

Pilot Study on the Effect of Mechanical Stimulation of Bone on ATP Release in Humans in Vivo

Maastricht University Medical Center1 site in 1 country10 target enrollmentOctober 2010
ConditionsOsteoporosis

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
December 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

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).

Study Sites (1)

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