Shock Wave Therapy for Osteoporosis

Osteoporosis Clinical Trial

— BOEST  

Official title:

Treatment of Osteoporosis With Unfocused Extracorporeal Shock Wave Therapy: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630381
• Other study ID #: NL40580.078.12
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2015
• Last updated: October 11, 2017
• Start date: May 18, 2015
• Est. completion date: September 19, 2016

Study information

• Verified date: October 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 19, 2016
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• female sex, age 50-80 years, normal dietary intake inclusive calcium and/or milk products and willing to participate

Exclusion Criteria:

• skin disease, systemic corticosteroid use, known systemic disease that interacts with bone (eg. rheumatoid arthritis, multiple myeloma, hyper(para)thyroidism, Paget's disease or Cushing's disease) or a previous wrist fracture

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Device:
• Unfocused extracoporeal shock wave therapy
Shock waves are acoustical pulses that are characterized by high amplitude (~500 bar) and short rise time (~20 ns), which are followed by a longer low-magnitude negative wave (~-100 bar). Extracorporeal shock waves are widely used to disintegrate kidney stones, which is called lithotripsy. In orthopedics, shock wave therapy, called orthotripsy, is used safely in a variety of musculoskeletal disorders like non unions, osteonecrosis of the hip, Achilles and patellar tendinopathy, lateral epicondylitis of the elbow and fasciitis plantaris. Until recently extracorporeal shock wave therapy for musculoskeletal disorders was applied with a focused character, in which the waves converge in a focal point similar to lithotripsy. For the prevention of fractures in osteoporosis a focused character is not preferable because large skeletal regions have to be treated, so unfocused shock waves have been developed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements		12 weeks
Primary	Bone mineral density will be assessed with the use of repeated dual energy X-ray		6 weeks
Secondary	Pain on the VAS scale		day before and first week after treatment
Secondary	Patient's side effects and complications on a questionnaire		12 weeks