Alendronate Safety Profile in Postmenopausal Women with Osteoporosis

Serious but Rare Adverse Events

The American College of Physicians suggests that the incidence of osteonecrosis of the jaw is less than 1 case per 100,000 person-years with osteoporosis dosing, but risk increases with longer duration of use 2
The incidence range of osteonecrosis of the jaw is 0.01-0.3% of users overall 3
Recent dental surgery or tooth extraction is the most consistent risk factor for osteonecrosis of the jaw 2
The US Preventive Services Task Force recommends ensuring dental work is completed before initiating or continuing bisphosphonate therapy to reduce the risk of osteonecrosis of the jaw 2
The incidence of atypical femoral fractures is 3.0-9.8 cases per 100,000 patient-years, and risk escalates significantly after 5 years of continuous use 2
Asian patients face up to 8 times higher risk of atypical femoral fractures compared to White patients 2
The risk-benefit context suggests that an estimated 162 osteoporosis-related fractures are prevented for every one atypical femoral fracture associated with treatment 2
If atypical femoral fracture occurs, stopping bisphosphonates can reduce contralateral fracture risk, which is otherwise 25% 2

The American Gastroenterological Association recommends taking alendronate with a full glass of water, remaining upright for at least 30 minutes, and avoiding food or drink during this period to minimize the risk of esophageal adverse events 2
Contraindications for alendronate include abnormalities of the esophagus and inability to stand or sit upright for at least 30 minutes 4

The US Preventive Services Task Force found no clear evidence of association between alendronate and atrial fibrillation 2
Bisphosphonates probably resulted in no differences in risk for atrial fibrillation in randomized controlled trials, with low certainty evidence 5, 6

The American College of Endocrinology recommends correcting vitamin D deficiency prior to initiation of bisphosphonate therapy, particularly for intravenous therapy, as deficiency may increase the risk of bisphosphonate-related hypocalcemia 2

High-quality evidence shows that bisphosphonates resulted in no differences in risk for serious adverse events compared to placebo in randomized controlled trials at 12-36 months 5, 6

The American College of Physicians recommends that treatment benefit reduces after 5 years, while the risk of atypical femoral fractures increases 2
High-certainty evidence demonstrates fracture reduction benefits through 5 years without significant increases in serious adverse events during this timeframe 1, 2
Patients at low risk for fracture should be considered for drug discontinuation after 3-5 years 5, 6

Denosumab is preferred in patients with renal impairment, with a creatinine clearance of less than 60 mL/min 2
The National Kidney Foundation recommends that zoledronic acid is contraindicated in patients with a creatinine clearance of less than 35 mL/min per 1.73 m² and acute renal impairment 4