Table 3 Key question 3 (benefits and harms of treatment) study eligibility criteria
Criteria | Include | Exclude |
|---|---|---|
Population | KQ3a: 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 |
Intervention | Pharmacotherapy 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) |
Comparator | KQ3a: 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) |
Outcomes | KQ3a:  ■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 |
Setting | KQ3a: Primary health care [117] KQ3b: Primary health care or long-term care | KQ3a: long-term care KQ3b: All other settings |
Study design and publication status | KQ3a:  ■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 |
Language | English or French | All other languages |
Date of publication | Any | Any |