Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

For 50 to 70 year old patients with low bone density, what is the comparative effectiveness of 6 Licensed Physical Therapist specified protocol (measured load bearing techniques and specific gait/balance movement training exercise treatment sessions) vs. no exercise training with BOTH groups receiving the same specified drug therapy (preferably the most recognized drug therapy product being prescribed currently)?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

1. Changes in diagnostic imaging bone density measures and distribution of bone density: In femoral neck, and in thoracic spine vertebral bodies pre- and post- intervention period of at least 6 months and with 18 to 24 month follow-up.

• These changes would be compared for age groups within population eg. age 50 to 55, age 56 - 60, age 61 - 65, etc.
• All participants would report their total minutes of loadbearing activity per day/week using a standardized diary system. Those values would be ranked and create another category group for comparative analysis - ie. between highest ave. minutes/day vs. lowest minutes/day groups vs. their bone density and distribution measures.

2. Incidence in fracture in vertebrae, pelvis, or femur of study groups.
3. Incidence in falls requiring medical visit: without fracture, with fracture
4. Changes in balance/gait measures predictive of falls including single leg stance, Tandem measures, gait velocity.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Male or female, age 50 to 70, active or sedentary, all living independently in home setting, all with low bone mineral density measures.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

1. Those with high loadbearing activity minutes per day vs. those with low loadbearing activity minutes per day.
2. Ethnic groups could be compared if represented equally in each group
3. Those participants who begin to exhibit EARLY DEMENTIA onset indicators should be compared between two study groups.
4. Those participants who report "joint pain/stiffness" or "arthritic pain/stiffness" should be compared between groups.
5. Low income participants should be compared between groups.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

1. Prevention of osteoporosis/low bone mineral density related fractures and associated loss of life quality measures, medical costs
2. Maximized improvement in osteoporosis patient treatment efficacy emphasizing qualified and quantified MOVEMENT/EXERCISE INTERVENTION and ACTIVITY MEASURES that are meaningful and applicable when an effective bone density drug therapy IS prescribed.
3. Reduction in osteoporosis population falls risk associated with balance and gait measures.

Describe any health-related risks, side effects, or harms that you are concerned about.

Side effects of prescribed bone density drug therapy included in study.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Dementia, including Alzheimer's disease
• Functional limitations and disability

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Financial and life quality benefits to all baby boomers and future aging populations who are not getting enough exercise as osteoporosis and fracture risks increase.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

In reviews of research being conducted, the comparison between drug therapies do not include enough focus on exercise or loadbearing

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

no

If yes, please explain:

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Describe the timeframe in which an answer to your question is needed.

Now - next 2 - 4 y

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

Are you making a suggestion as an individual or on behalf of an organization?

Individual

Please tell us how you heard about the Effective Health Care Program