Draft Research Plan
Osteoporosis to Prevent Fractures: Screening
June 18, 2015
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.
* Osteoporosis defined as a T-score of ≤−2.5; low bone mass defined as a T-score of −1.0 to −2.5.
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.
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?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the evidence from modeling studies about different risk thresholds for identifying patients who should have bone measurement testing?
- 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?
| 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:
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:
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:
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:
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:
KQs 2, 3: Observational studies other than case series and case reports KQs 4, 5: Systematic reviews KQ 4d: In addition:
|
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 |