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The LIFTMOR-M (Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men) trial: protocol for a semirandomised controlled trial of supervised targeted exercise to reduce risk of osteoporotic fracture in older men with low bone mass
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  • Published on:
    Response to Dr Conviser's comments
    • Belinda R Beck, Academic/Researcher Menzies Health Institute QLD and School of Allied Health Sciences, Griffith University
    • Other Contributors:
      • Amy T Harding, PhD student
      • Benjamin K Weeks, Academic/Researcher
      • Steven L Watson, PhD student

    Dear Dr Conviser,

    Thank you for your comments. Please find our responses to those comments below, itemised 1 to 6:

    1. Your protocol calls for 8 months of exposure to the bio Density system. Manufacturers recommendations supported by peer reviewed studies have shown that BMD changes require a minimum of 9 months and many individuals begin to show changes with DEXA at the 11 and 12 month period.

    OUR RESPONSE:
    Could you please clarify to which specific manufacturer recommendations and peer-reviewed studies you refer?
    We note that BMD changes have indeed been observed within 6 months when an intervention has been sufficiently intense [1]. A single BMU will complete a full remodelling cycle in roughly 4 months, but we certainly agree the mineralisation lag limits sensitivity of ionising radiation devices to detect change before 6 months [2]. We therefore balanced an imperative to apply our intervention for longer than 6 months to increase our opportunity to detect a BMD treatment effect, with the requirement to complete the trial within the time period that we have access to the bioDensity device. Our confidence that 8 months will provide a sufficient intervention duration is derived from the BMD response observed in the LIFTMOR trial for women where we applied the identical training duration (see early findings publication [3] - final outcomes are under revision.) In light of your concerns, we are interested in the rationale behind your ch...

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    Conflict of Interest:
    None declared.
  • Published on:
    Jason Conviser, Ph.D., FACSM
    • Jason Conviser, Exercise Physiologist Consultant to Performance Health Systems

    I have read the protocol for The LIFTMOR-M (Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men) trial: protocol for a semi-randomised controlled trial of supervised targeted exercise to reduce risk of osteoporotic fracture in older men with low bone mass and have questions and concerns that I wish your consideration and response:
    1. Your protocol calls for 8 months of exposure to the bio Density system. Manufacturers recommendations supported by peer reviewed studies have shown that BMD changes require a minimum of 9 months and many individuals begin to show changes with DEXA at the 11 and 12 month period.
    2. Those studies which have shown changes in DEXA as a result of bio Density exposure have done so with subjects who are in osteopenia and not osteoporosis. Your inclusion of males in osteopenia could complicate analysis and conclusions. The best that we have seen is a baseline of those with osteopenia (not getting worse). Also the greater the negative DEXA (ie -3.0, or greater we have seen the greatest change with bio Density exposure). Regression to the mean can be expected.
    3. The protocol allows for 2 x per week exposure. The manufacturers recommendations call for once a week.
    4. I question if it is appropriate to ask 50 year old men to not perform any form of exercise for 8 or more months while participating in this study. Will the health risk of not exercising be acceptable to the IRB? Other st...

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    Conflict of Interest:
    None declared.