Skip to navigation bar Skip to breadcrumbs Skip to page content Skip to comments area
clear place holder
Envelope icon E-mail Updates Teal square Text size:  a A A
You are here: HomePublic Comments and NominationsOpportunity for Public CommentDraft Research Plan : Draft Research Plan

Draft Research Plan

Draft Research Plan for Osteoporosis to Prevent Fractures: Screening

This opportunity for public comment expired on July 15, 2015 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Send Us Your Comments

In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

Comment period is not open at this time.

Draft: Proposed Analytic Framework

* Osteoporosis defined as a T-score of ≤−2.5; low bone mass defined as a T-score of −1.0 to −2.5.

Text Description.

This figure is an analytic framework depicting the proposed key questions (KQs) to be addressed in the systematic review. This figure illustrates the screening pathway for the population of interest, namely asymptomatic adults age 40 years and older without known reasons for secondary osteoporosis. The overarching question (KQ 1) for the review is whether screening for osteoporosis, low bone mass, or high fracture risk reduce fractures and fracture-related morbidity and mortality. KQs 2a and 2b relate to the accuracy and reliability of validated risk assessment tools and the evidence to support the use of different thresholds based on risk assessment. KQ 2c focuses on the evidence for risk assessment and bone measurement screening intervals. KQ 2d examines how well peripheral dual energy x-ray absorptiometry and qualitative ultrasound predict fracture risks. For the subset of the population at increased risk, KQ 3 examines the harms of screening for osteoporosis, low bone mass, or high fracture risk. For persons with osteoporosis or low bone mass, KQ 4 examines the relationship between treatment of osteoporosis and outcomes (specifically fractures and fracture-related morbidity and mortality). Finally, as part of the assessment of treatment, KQ 5 examines the harms associated with pharmacotherapy for the prevention or treatment of osteoporosis or low bone mass.

Draft: Proposed Key Questions to Be Systematically Reviewed

1. Does screening (clinical risk assessment, bone measurement testing, or both) for osteoporosis (defined as a T-score of ≤−2.5), low bone mass (defined as a T-score of −1 to −2.5), or high fracture risk reduce fractures and fracture-related morbidity and mortality in asymptomatic adults age 40 years and older without known reasons for secondary osteoporosis?

2a. What is the accuracy and reliability of validated risk assessment approaches to identify adults who are at increased risk for osteoporosis, low bone mass, or high fracture risk?

2b. What is the evidence to support the use of different thresholds, based on risk assessment, for identifying patients who should have bone measurement testing?

2c. What is the evidence to determine risk assessment and bone measurement screening intervals?

2d. How well do peripheral dual energy x-ray absorptiometry and qualitative ultrasound predict fracture risk?

3. What are the harms of screening (clinical risk assessment, bone measurement testing, or both) for osteoporosis, low bone mass, or high fracture risk?

4a. What is the effectiveness of pharmacotherapy for the treatment of osteoporosis (defined as a bone mass T-score of ≤−2.5), specifically in reducing fracture-related morbidity and mortality?

4b. What is the effectiveness of pharmacotherapy for the prevention of osteoporosis in persons with low bone mass (defined as a T-score of −1.0 to −2.5), specifically in reducing fracture-related morbidity and mortality?

4c. What is the effectiveness of pharmacotherapy for the prevention of osteoporosis in persons with low bone mass or for the treatment of osteoporosis by subgroup, specifically in postmenopausal women, premenopausal women, men, younger age groups (age <65 years), and older age groups (age ≥65 years)?

4d. What is the effectiveness of pharmacotherapy for the reduction of fracture-related morbidity and mortality in patients with low bone mass, as measured by peripheral dual energy x-ray absorptiometry or qualitative ultrasound?

5. What are the harms associated with pharmacotherapy for the prevention of osteoporosis in persons with low bone mass or for the treatment of osteoporosis?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the evidence from modeling studies about different risk thresholds for identifying patients who should have bone measurement testing?
  2. What is the evidence from modeling studies about the effectiveness of screening strategies (screening, risk assessment, or bone measurement) that use a) different ages at which to start and stop screening and b) different screening intervals?

Draft: Proposed Research Approach

  Include Exclude
Populations KQs 1–3: Asymptomatic men and women age ≥40 years

KQs 4, 5: Adults age ≥40 years with low bone mass (defined as a T-score of −1.0 to −2.5) or osteoporosis (defined as a T-score of ≤−2.5)

KQs 1–5:
  • Majority of study population has known reasons for secondary osteoporosis (e.g., untreated premature ovarian failure or surgical menopause, endocrine disorder such as thyroid, parathyroid, or Cushing disease, chronic use of glucocorticoid medications) or is already receiving treatment
  • Nonhuman populations
  • Majority of study population comprises adults younger than age 40 years

KQs 4, 5: Adults with normal bone mass (defined as a T-score of >−1.0)

Interventions KQs 1–3: Risk assessment tool for low bone mass and/or high fracture risk, bone measurement testing, or both (available in the United States)

KQs 4, 5: Pharmacotherapy approved by the U.S. Food and Drug Administration for the treatment or prevention of osteoporosis

KQs 1–3:
  • Not risk assessment or bone measurement testing
  • Screening intervention not available in the United States

KQs 2, 3: Not diagnostic test

KQs 4, 5: Interventions not described in the inclusion criteria

Comparators KQ 1 (control interventions): Usual care or no screening group

KQs 2, 3 (control interventions): Other risk assessment/testing approach, threshold, or interval

KQ 4 (control interventions): Placebo

KQ 5 (control interventions): Placebo or no treatment

KQ 1 (control interventions): Lack of usual care or no screening group (active comparator)

KQs 2, 3 (control interventions): Not an active comparator

KQs 4, 5 (control interventions): Active comparator

Outcomes All KQs: Fractures, fracture-related morbidity, fracture-related mortality, or all-cause mortality

KQs 2, 3:

  • Screening test characteristics of risk assessment, bone mass measurement, or both (e.g., sensitivity, specificity)
  • Fracture risk

KQ 3: Harms (e.g., unnecessary radiation, labeling, anxiety, false-positive results)

KQ 5: Harms (e.g., cardiovascular events, hot flashes, esophageal cancer, gastrointestinal events, osteonecrosis of the jaw, atypical fractures of the femur, rashes)

KQ 1:
  • Nonvalidated fractures, fracture-related morbidity, or fracture-related mortality
  • Bone measurement testing (T-scores, z-scores)

KQs 2–4: Outcomes other than those described in the inclusion criteria

KQ 5: None

Timing KQ 1: ≥6 months following screening

KQs 2, 3: All timings

KQs 4, 5: ≥6 months following initiation of treatment

KQ 1: Within 6 months of screening

KQs 2, 3: None

KQs 4, 5: Within 6 months of initiation of treatment

Settings All KQs: U.S. adult population or comparable populations (i.e., those categorized as “Very High” on the Human Development Index, as defined by the United Nations Development Programme)

KQ 1: Primary care or primary care–like settings

KQs 2–5: Primary care or primary care–like settings, specialists

All KQs: Settings not comparable or applicable to U.S. adult population

KQ 1: Inpatient, medical specialty (e.g., endocrinology), or nursing home settings

KQs 2–5: Inpatient or nursing home settings

Study designs KQs 1–3:
  • Randomized, controlled trials
  • Controlled clinical trials
  • Systematic reviews of trials

KQs 2, 3: Observational studies other than case series and case reports

KQs 4, 5: Systematic reviews

KQ 4d: In addition:

  • Randomized, controlled trials
  • Controlled clinical trials
KQ 1: Nonrandomized, controlled trials; noncontrolled clinical trials, or nonsystematic reviews of trials

KQs 2, 3: Case series, case reports

KQs 4, 5: Nonsystematic review

KQ 4d: Nonrandomized, controlled trials or noncontrolled clinical trials

Quality Good and fair quality Poor quality
Language English Languages other than English
Publication type KQs 1–3: Published or unpublished original research

KQs 4, 5: Published or unpublished systematic reviews

KQs 1–3: Nonsystematic review article, letter, or editorial; articles in which results are reported elsewhere; articles with no original data

KQs 4, 5: Nonsystematic review article, letter, or editorial; articles in which results are reported elsewhere

Date of search November 1, 2009 onward Before November 1, 2009
Current as of: June 2015

Internet Citation: Draft Research Plan: Osteoporosis to Prevent Fractures: Screening. U.S. Preventive Services Task Force. June 2015.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan181/osteoporosis-screening1

USPSTF Program Office   5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857