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 1
- 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 1
- Other rare side effects: such as atrial fibrillation, bone pain, and esophageal cancer, although the evidence for these associations is limited and inconclusive 1
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 1
- Dental examination: patients should undergo a dental examination and receive prophylactic measures before starting bisphosphonate therapy to minimize the risk of ONJ 1
- 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 1
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. 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 2
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 3, 4, 5, 6
- Acute phase reactions for intravenous forms 3, 5
- Hypocalcaemia and renal injury, which could be potentially serious 3, 5
- Severe musculoskeletal pain and ocular events, which may be ignored by physicians, delaying their diagnosis and management 3
- Osteonecrosis of the jaw, more common in cancer sufferers who receive high doses of intravenous bisphosphonates 3, 5, 7
- Atypical femoral fractures, very rare compared with osteoporotic fractures that bisphosphonates prevent 3, 5, 7
- Association with esophageal cancer, hepatotoxicity, and atrial fibrillation, which remains doubtful or not well supported by current data 3, 4, 7
- Cutaneous reactions, oral ulcerations, and hepatitis, with a few case reports relating bisphosphonates to these conditions 5
- Renal toxicity, associated with intravenous bisphosphonates such as pamidronate and zoledronic acid 5