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Shock Wave Therapy for Osteoporosis (BOEST)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Unfocused extracoporeal shock wave therapy
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring high-energy shock waves

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Shock wave arm

    Contra-lateral arm

    Arm Description

    Unfocused extracorporeal shock wave therapy will be applied on the distal radius on one site when the patient is receiving general anaesthesia for surgery on the lower extremity or spine.

    The distal radius and/or wrist that did not receive UESWT will not be treated

    Outcomes

    Primary Outcome Measures

    Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements
    Bone mineral density will be assessed with the use of repeated dual energy X-ray

    Secondary Outcome Measures

    Pain on the VAS scale
    Patient's side effects and complications on a questionnaire

    Full Information

    First Posted
    December 7, 2015
    Last Updated
    October 11, 2017
    Sponsor
    UMC Utrecht
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02630381
    Brief Title
    Shock Wave Therapy for Osteoporosis
    Acronym
    BOEST
    Official Title
    Treatment of Osteoporosis With Unfocused Extracorporeal Shock Wave Therapy: Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 18, 2015 (Actual)
    Primary Completion Date
    September 19, 2016 (Actual)
    Study Completion Date
    September 19, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    UMC Utrecht

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    high-energy shock waves

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Shock wave arm
    Arm Type
    Experimental
    Arm Description
    Unfocused extracorporeal shock wave therapy will be applied on the distal radius on one site when the patient is receiving general anaesthesia for surgery on the lower extremity or spine.
    Arm Title
    Contra-lateral arm
    Arm Type
    No Intervention
    Arm Description
    The distal radius and/or wrist that did not receive UESWT will not be treated
    Intervention Type
    Device
    Intervention Name(s)
    Unfocused extracoporeal shock wave therapy
    Other Intervention Name(s)
    Extracorporeal shock waves, Extracorporeal shock wave therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements
    Time Frame
    12 weeks
    Title
    Bone mineral density will be assessed with the use of repeated dual energy X-ray
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Pain on the VAS scale
    Time Frame
    day before and first week after treatment
    Title
    Patient's side effects and complications on a questionnaire
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Shock Wave Therapy for Osteoporosis

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