Table 1.

Source of evidence for adverse reactions to treatments in osteoporosis

	Source of evidence			Duration of postapproval experience in 2010
	RCT	Pharmacovigilance	Case series
Bisphosphonates				Alendronate, 15 years Risedronate, 10 years Ibandronate (oral), 5 years Ibandronate (IV), 4 years Zoledronic acid, 3 years
GI effects	✓	✓
Musculoskeletal pain		✓
Acute-phase reactions	✓	✓
Atrial fibrillation	✓	✓
Atypical fracture/delayed fracture healing		✓	✓
Osteonecrosis of the jaw		✓	✓
Hypersensitivity reactions		✓	✓
Renal impairment		✓
Denosumab				New agent
Severe infection	✓
Osteonecrosis of the jaw		✓	✓
Cancer	✓
SERMs				Raloxifene, 13 years Bazedoxifene, new agent Lasofoxifene, new agent
Hot flushes	✓	✓
Leg cramps	✓	✓
Venous thromboembolism	✓	✓
Stroke	✓
Endometrial effects	✓
Strontium ranelate				8 years
Venous thromboembolism	✓
Hypersensitivity reactions		✓	✓
Teriparatide or PTH(1–84)				8 years
Headache, nausea, dizziness, and limb pain	✓	✓
Osteosarcoma		✓	✓