Table 4: Adverse events of denosumab in GIOP.

Study

Adverse events/reactions

Denosumab

Bisphosphonates

Suzuki 2018

No serious adverse event, such as hypocalcemia or atypical bone fracture, occurred during the study.

N/A

Iseri [32]

Skin rash (n = 1)
Pulmonary tuberculosis (n = 1)
Hypocalcemia (n = 2)
Femur neck fracture (n = 1)

none

Akashi [27]

Not reported

N/A

Dore [26]

Adverse events were comparable between denosumab and placebo groups

N/A

Ishiguro [24]

Hypocalcemia (n = 0)

Jaw osteonecrosis (n = 0)
Atypical femoral fracture (n = 0)

N/A

Sawamura [25]

Upper respiratory infections (n = 2)

N/A

Iwamoto [29]

Herpes zoster (n = 2)
Pneumonia (n = 1)
Upper respiratory infection (n = 2)
Acute gastritis (n = 1)
Gastric ulcer (n = 1)
Fragility fracture (n = 2)
Colon cancer (n = 2)

N/A

Saag [31]

Pneumonia (n = 5)

Cardiac failure (n = 3)

Transient ischemic attack (n = 3)
Atypical femoral fracture (n = 1)

Osteoporosis related fractures (n = 26/398)

Malignancy (n = 5)
Back pain (n = 18)
Arthralgia (n = 17)
Hypertension (n = 15)
Diverticulitis (n = 1)

Pyelonephritis acute (n = 1)

Anti-denosumab antibody (n = 1)

Pneumonia (n = 6)

Osteoporosis related fractures (n = 23/397)

Malignancy (n = 3)
Back pain (n = 17)

Arthralgia (n = 21)

Hypertension (n = 13)

Diverticulitis (n = 1)

Pyelonephritis acute (n = 1)

Bronchitis (n = 2)

Kadoba [33]

Osteonecrosis of the jaw (n = 1)

Transient hypocalcemia (n = 3)

Osteoporotic fractures (n = 7)

Avascular necrosis of femoral head (n = 8)

Osteonecrosis of the jaw (n = 1)

Transient hypocalcemia (n = 6)

Tanaka [34]

Vertebral fracture (n = 2)

Vertebral fracture (n = 24)

Yoshi [30]

Not reported

Not reported

Mok [35]

Fever after injection (n = 1)
Infective episodes (n = 7)
Dyspepsia/reflux (n = 3)
Dizziness/vertigo (n = 2)
High blood pressure (n = 1)
Arthralgia (n = 1)
Skin rash (n = 1)
Alopecia (n = 1)
Keratitis (n = 1)

Infective episodes (n = 1)
High blood pressure (n = 1)
Arthralgia (n = 1)
Skin rash (n = 1)
Menorrhagia (n = 1)

N/A- not applicable.