Skip to main content

Advertisement

Table 3 Key question 3 (benefits and harms of treatment) study eligibility criteria

From: Screening to prevent fragility fractures among adults 40 years and older in primary care: protocol for a systematic review

CriteriaIncludeExclude
PopulationKQ3a:
Adults ≥ 40 years in the general population who are at risk of (as per study authors) fragility fracture (we will include studies where ≥ 80% of the sample or the sample mean age − 1 standard deviation is ≥ 40 years)
KQ3b:
Adults ≥ 40 years who are at risk of fragility fracture
Subgroups for decision-making: age, sex, menopausal status
Methods subgroups (KQ3a): prior fracture, predicted fracture risk, length of follow-up
KQ3a:
 ■ Adults < 40 years (mean age – 1 standard deviation < 40)
 ■ > 50% with prior fragility fracture, endocrine or other disorders likely to be related to metabolic bone disease, chronic use of glucocorticoid medications, cancer
KQ3b:
 ■ Adults < 40 years
 ■ Endocrine or other disorders likely related to metabolic bone disease, cancer
InterventionPharmacotherapy currently approved by Health Canada for the treatment of osteoporosis or prevention of fragility fractures (see Additional file 3) that is commonly used in Canada as a first-line treatment:
 ■ Bisphosphonates (alendronate, risedronate, zoledronic acid only); harms of bisphosphonates as a class will be included if > 90% of participants are taking alendronate or risedronate, or if within-study subgroup analysis for these drugs is available
 ■ Denosumab
Adjunct calcium and/or vitamin D (but not other drugs) will be included if it is used identically in both the intervention and comparison group
 ■ Pharmacotherapies not commonly used in Canada: hormone therapy, etidronate, raloxifene, teriparatide, calcitonin (no longer recommended)
 ■ 5 mg/day dosage of alendronate
 ■ Drugs used in combination
 ■ Off-label pharmaceuticals and dosages
 ■ Natural health products, dietary supplements (e.g., vitamins, minerals)
 ■ Complex interventions (e.g., pharmacotherapy + exercise)
ComparatorKQ3a: Placebo
KQ3b: Placebo or no treatment; no comparator for the outcomes of osteonecrosis of the jaw and atypical femoral fractures
In both cases adjunct calcium and/or vitamin D will be included if it is used identically in both the intervention and comparison group.
 ■ Other drugs, dosages, or drug combinations
 ■ Complex interventions (e.g., pharmacotherapy + exercise)
OutcomesKQ3a:
 ■ Hip fractures
 ■ Fracture-related mortality
 ■ Functionality and disability (includes surrogate measures such as frailty questionnaires and long-term care admissions)
 ■ Quality of life or well being
 ■ All clinical fragility fracturesa
 ■ All-cause mortality
KQ3b:
 ■ Discontinuations due to adverse events
 ■ Serious AEsb including all serious cardiovascular events; serious cardiac rhythm disturbances (e.g., serious atrial fibrillation or ventricular arrhythmia); serious gastrointestinal events (excluding cancers); gastrointestinal cancer; atypical femoral fractures; osteonecrosis of the jaw; fractures related to rebound effects after stopping treatment
 ■ Non-serious adverse events (including any adverse events or adverse (drug) reactions; any non-serious adverse events)
 
Timeframe≥ 6 months follow-up< 6 months follow-up
SettingKQ3a: Primary health care [117]
KQ3b: Primary health care or long-term care
KQ3a: long-term care
KQ3b: All other settings
Study design and publication statusKQ3a:
 ■ Randomized controlled trials
 ■ Manuscripts, reports, abstracts, dissertations, and clinical trials registers, if data are available
KQ3b:
 ■ Randomized controlled trials
 ■ Controlled observational studies (> 1000 participants) for serious adverse events only
 ■ Uncontrolled cohort studies for osteonecrosis of the jaw and atypical fractures only
 ■ Manuscripts, reports, abstracts, dissertations, and clinical trials registers if data are available
KQ3a:
 ■ Systematic reviews, meta-analyses, and pooled analyses
 ■ All other primary study designs
 ■ Non-research (e.g., editorials)
 ■ Studies available only as conference proceedings or other grey literature, unless data are available and adequate to assess risk of bias
KQ3b:
 ■ Systematic reviews, meta-analyses, and pooled analyses
 ■ Non-research (e.g., editorials)
 ■ Studies available only as conference proceedings or other grey literature, unless data are available and adequate to assess risk of bias
 ■ Case reports and series
LanguageEnglish or FrenchAll other languages
Date of publicationAnyAny
  1. a Clinical fragility fractures include only symptomatic and radiologically confirmed fractures; sites per author definition, and may be defined as major osteoporotic fracture.
  2. b A serious adverse event is any untoward medical occurrence that at any dose (a) results in death, (b) is life-threatening, (c) requires inpatient hospitalization or prolongation of existing hospitalization, (d) results in persistent or significant disability/incapacity, (e) is a congenital anomaly/birth defect, (f) is a medically important event or reaction [118]