From the Guidelines
Alendronate, a bisphosphonate, is associated with several risks, including mild upper GI symptoms, atypical subtrochanteric fractures, and osteonecrosis of the jaw, although the incidence of these events is rare.
Risks Associated with Alendronate
- Mild upper GI symptoms: such as esophagitis, dysphagia, and gastric ulcers, which can be mitigated by taking the medication with plenty of water and remaining upright for at least 30 minutes after administration 1
- Atypical subtrochanteric fractures: a rare but potentially serious side effect, with an incidence ranging from 3.0 to 9.8 cases per 100,000 patient-years 2
- Osteonecrosis of the jaw (ONJ): a rare but serious side effect, with an incidence of less than 1% to 10% in patients receiving intravenous bisphosphonates, and less than 10,000-100,000 in patients receiving oral bisphosphonates for osteoporosis 3
- Other rare side effects: such as atrial fibrillation, bone pain, and esophageal cancer, although the evidence for these associations is limited and inconclusive 2, 3 ### Important Considerations
- Patient education: clinicians should discuss the importance of adherence to bisphosphonate therapy, as well as the potential risks and side effects, with their patients 4
- Dental examination: patients should undergo a dental examination and receive prophylactic measures before starting bisphosphonate therapy to minimize the risk of ONJ 3
- Monitoring: patients receiving bisphosphonates should be monitored for signs of upper GI symptoms, atypical fractures, and ONJ, and clinicians should be aware of the potential for rare but serious side effects 2, 3
From the FDA Drug Label
In placebo-controlled clinical studies of alendronate sodium, the percentages of patients with these symptoms were similar in the alendronate sodium and placebo groups. 5. 4 Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including alendronate sodium.
- 5 Atypical Subtrochanteric and Diaphyseal Femoral Fractures Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. 5.6 Renal Impairment Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min.
The risks associated with Alendronate (bisphosphonate) include:
- Osteonecrosis of the Jaw (ONJ): associated with tooth extraction, local infection, and delayed healing
- Atypical Subtrochanteric and Diaphyseal Femoral Fractures: low-energy or low trauma fractures of the femoral shaft
- Renal Impairment: not recommended for patients with creatinine clearance less than 35 mL/min These risks should be considered on an individual basis, with treatment interruption or discontinuation considered pending a risk/benefit assessment 5
From the Research
Risks Associated with Alendronate (Bisphosphonate)
The following are some of the risks associated with Alendronate (bisphosphonate):
- Upper gastrointestinal discomfort, including abdominal pain, nausea, dyspepsia, acid regurgitation, and musculoskeletal pain 6, 7, 8, 9
- Acute phase reactions for intravenous forms 6, 8
- Hypocalcaemia and renal injury, which could be potentially serious 6, 8
- Severe musculoskeletal pain and ocular events, which may be ignored by physicians, delaying their diagnosis and management 6
- Osteonecrosis of the jaw, more common in cancer sufferers who receive high doses of intravenous bisphosphonates 6, 8, 10
- Atypical femoral fractures, very rare compared with osteoporotic fractures that bisphosphonates prevent 6, 8, 10
- Association with esophageal cancer, hepatotoxicity, and atrial fibrillation, which remains doubtful or not well supported by current data 6, 7, 10
- Cutaneous reactions, oral ulcerations, and hepatitis, with a few case reports relating bisphosphonates to these conditions 8
- Renal toxicity, associated with intravenous bisphosphonates such as pamidronate and zoledronic acid 8