Osteoporosis affects men, too!
Osteoporosis affects more than 2 million men in the United States today and nearly 12 million more have osteopenia. Osteoporosis is the cause of 85% of all hip fractures and 90% of vertebral fractures in men, but, nevertheless, often goes undiagnosed and inadequately treated. Unlike women who are often identified as osteopenic or osteoporotic via routine DXA scan, men are usually diagnosed with osteoporosis only after experiencing a fragility fracture, back pain or diminished stature. However, even after suffering an osteoporosis-related fracture, >90% of men remain undiagnosed and untreated. Post-fracture, men are less likely to receive follow-up care than women, including calcium and vitamin D supplementation and prescription of anti-resorptive pharmacotherapy.
Research on effective treatment of male osteoporosis is severely lacking
The majority of osteoporosis treatment and prevention studies, including pharmacologic interventions, have been conducted in female populations. Although antiresorptive medications are an FDA-approved treatment for osteoporosis in males, less than 10% of men with osteoporotic fractures are treated with bisphosphonates. Enthusiasm for use of these medications in men appears to be limited by the relative lack of long-term safety and efficacy studies in men, the especially poor treatment compliance in males, and data suggesting poor cost effectiveness of bisphosphonate treatment in men. Exercise-based interventions are an attractive alternative to medication due to the reduced cost, fewer serious side effects, e.g., severe suppression of bone turnover and gastrointestinal complications, and additional health benefits, including improved balance and fall reduction. Resistance training and structured jump-training interventions increase BMD of the spine in girls and pre- and post-menopausal women. Data supporting the efficacy of activity-based interventions to increase BMD in adult males with osteopenia are virtually non-existent. Because body composition and hormonal status modify bone response to mechanical loading, there may be sex differences in the response to exercise-based interventions. Thus, studies that aim to identify safe and effective, yet practicable, exercise-based interventions to increase BMD in adult men with osteopenia are desperately needed.
Goal of the present study: exercise-based treatment for low bone mass in men
The overall goal of this research project is reduction in both the personal and societal costs associated with low bone density and related fractures in men. The availability of a well-defined exercise-based treatment with demonstrated effectiveness will increase overall treatment accessibility and compliance, thereby reducing both the number of incident fractures and fracture-related mortality.
This study is being done to determine if either plyometrics (jump training) or resistance training (along with calcium and vitamin D supplementation) for 12 months will increase bone mass in men with low bone mineral density who are otherwise healthy.
This study consists of two phases; the Screening Phase and the Experimental Phase.
During the Screening Phase, you will meet with the study coordinator so we can explain the study more thoroughly to you. You will also read the consent form.
IF YOU CHOOSE, YOU MAY GO HOME AND DISCUSS YOUR POTENTIAL PARTICIPATION IN THIS STUDY WITH YOUR FAMILY AND FRIENDS.
If you decide to participate, you will sign the consent form and have your bone mineral density measured by dual-energy X-ray (DXA). During the DXA scan, you will be required to lie still for approximately 10 minutes and you will be exposed to a small amount of radiation (equivalent to 1/10th of a chest x-ray). You will be provided with the results of your bone density scan. You will also fill out a medical and physical activity history questionnaire and a physical activity readiness questionnaire (PAR-Q).
If you qualify for the study, you will be randomly assigned to either the resistance training or plyometric treatment. You will also be given a diet and physical activity log to fill out for one week every three months. For the next 12 months, you will perform the prescribed training in McKee Gym under the supervision of study personnel 2-3 times per week between 6:00 AM and 7:00 PM, Monday through Friday.
During this phase, you will have a small amount (about a tablespoon) of blood drawn for measurement of markers of bone turnover and hormones. This will occur at the beginning of the study and every three months thereafter. We will also retest your bone mineral density using DXA after 6 months and at the end of the study. All procedures will be provided at no cost to you.
You will also have to fill out a diet and physical activity log for one week every three months during your participation.
You will be required to take a calcium/vitamin D supplement daily.
You will receive $1000 compensation upon completion of the study.
IF YOU ARE ELIGIBLE:
FOR THE 12 MONTH INTERVENTION
You must not:
If you are interested in participation, you will be required to:
If you meet the eligibility requirements for the study, you will be required to:
There are many benefits of participation in this study, including:
Exercise sessions will take place in McKee Gym (on the MU campus) under the supervision of research staff. All procedures will also be performed in McKee Gym.
Consent Form (PDF)
For more information, contact:
Peggy Nigh, Study Coordinator
Phone: (573) 882-9917
Screening and Consent
Q: When does the study start, and when can I come in?
A: The study has already started. Call or email the Study Coordinator and we will make every effort to accommodate your schedule.
Contact information for the Study Coordinator, Peggy Nigh:
Phone: (573) 882-9917
Q: How long does the screening and consent meeting last?
A: 45-60 minutes.
Q: Is the DXA scan safe?
A: Yes. The DXA scan produces very little radiation. It is equivalent to 1/10th of a chest X-ray.
Q: When do I get to see the DXA results?
A: DXA results will be provided to you at the beginning and end of the study.
Q: Will I get copies of the study results for my personal records?
A: Yes. We will provide you a copy of your results.
Q: I am active at my job. Does that contribute to the amount of physical activity I participate in each week?
A: No. Only planned, structured, leisure time physical activity is counted toward the 4 hours of physical activity per week you must do to participate in the study.
Q: Can I still do my regular exercise?
A: Yes, we ask you to continue your regular exercise routine.
Q: I have never done resistance training or plyometrics. Can I still participate?
A: Yes. Trained personnel will demonstrate techniques and ensure you understand how to properly complete the exercise.
Q: How often do I have to come in?
A: If you are randomized into the resistance training group, you will need to come in 2 times per week on non-consecutive days. If you are randomized into the plyometrics group, you will need to come in 3 times per week.
Q: How long do the exercise sessions last?
A: The resistance exercise training lasts approximately 1 hour. The plyometrics exercise training lasts approximately 30 minutes.
Q: Do I have to warm up before exercise?
A: Yes. You will complete 10 minutes of a warm-up in McKee Gym. You have the option to run or cycle to McKee Gym as your warm up.
Q: What is the intensity of the exercise sessions?
A: The exercise sessions will increase in intensity, from light to heavy, as the 6 week exercise cycle progresses.
Q: Will I be supervised?
A: Yes. There will be trained study personnel supervising you.
Q: Is there a place I can keep my personal belongings while exercising?
A: Yes, there are lockers available. However, you must provide your own lock.
Q: Can I use the gym to work out?
A: No, the gym is reserved for your study-related training sessions.
Exercise Testing and Blood Draws
Q: How much blood do you take during blood draws?
A: We will collect approximately 15 mL (~0.5 ounce) of blood 3 times during the 24-hour period following a high-intensity plyometrics or resistance training session at the beginning, 6 months, and 12 months into the study. In addition, we will collect 15 mL of blood at 3 and 9 months into the study.
Q: Do I have to fast before testing?
A: You must fast only before blood draws. Before blood draws, you must fast for 10 hours prior to exercise testing.
Q: Do I have to change my diet during the study?
A: No, you may follow your usual diet throughout the study.
Q: How much money would I receive for participation, and when would I be paid?
A: You will be compensated $1000 after completion of all study-related procedures. If you complete only 6 months of the study, you will receive $300. You will not receive any compensation for completing less than 6 months of the study.
Q: Is there parking available?
A: Yes. There is temporary parking available during your exercise session.
Q: What if I have to be out of town?
A: We appreciate advanced notice of your absence and will try to adjust accordingly.
Q: What happens if I get too far behind on exercise sessions?
A: We will remind you as you begin to fall behind. However, if you fall too far behind, you will be removed from the study.
Q: Can I bring someone with me (e.g. spouse, child, or friend) to my exercise training sessions?
A: The exercise facilities in McKee Gym are dedicated to research and, therefore, are available only to study participants. We would prefer you do not bring an additional person unless absolutely necessary.
Primary Investigator: Dr. Pam Hinton, Associate Professor of Nutrition & Exercise Physiology
Co-Investigator: Dr. John Thyfault, Assistant Professor of Nutrition & Exercise Physiology
Study Research Coordinator: Peggy Nigh
Exercise Physiology Graduate Student: Melissa Carter
Exercise Physiology Graduate Research Assistant: Tim Sinak
Exercise Physiology Graduate Research Assistant Jiang Jun (JJ)
Undergraduate Research Assistant: Lynn Eaton
Links to Related Research Studies from Dr. Hinton’s Lab:
Links to News Articles About Dr. Hinton’s Research: