Osteoporosis Clinical Trial
Official title:
Treatment of Osteoporosis With Unfocused Extracorporeal Shock Wave Therapy: Pilot Study
Rationale: Osteoporotic fractures are associated with high morbidity and mortality. This is
why prevention of these fractures is important. The investigators have shown in animal
studies that a single treatment with unfocused extracorporeal shock wave therapy leads to
highly increased bone mass and improved biomechanical properties. Unfocused extracorporeal
shock wave therapy could have important implications for the prevention of osteoporotic
fractures.
Objective: To assess the effect of unfocused extracorporeal shock wave therapy on bone mass.
Study design: A clinical pilot study. Study population: Twelve female patients are eligible
if they are undergoing elective surgery of the lower extremity or elective spinal surgery
under general anesthesia in the investigators hospital.
Intervention: When the patient is under general anaesthesia he/she will receive 3000
unfocused extracorporeal shock waves (energy flux density 0.3mJ/mm2) to one distal forearm.
The contra lateral forearm will not be treated and serves as a control.
Main study parameters/endpoints:
The investigators will examine the effect on bone mass with the use of repeated dual energy
X-ray absorptiometry measurements. These results are necessary to calculate the number of
patients that are needed for larger studies. Furthermore, the investigators will assess
patient's discomfort.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: General anaesthesia is performed during treatment and pain after the procedure
will be evaluated using pain scales and, if necessary pain medication will be prescribed by
the orthopaedic surgeon. The dual energy X-ray absorptiometry-scans and X-rays will cause
very low radiation exposure to the patient.
n/a
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