Is alendronate (bisphosphonate) contraindicated in an 83-year-old female with osteoporosis, impaired renal function (GFR 31, creatinine (crea) 1.75), and a history of breast cancer?

From the Guidelines

Alendronate is contraindicated in this 83-year-old female patient due to her impaired renal function, with a GFR of 31 mL/min and creatinine of 1.75 mg/dL, which falls below the recommended threshold for bisphosphonate therapy. According to the American College of Physicians guideline update 1, alendronate is recommended for patients with osteoporosis, but its use in patients with severe renal impairment is not supported due to the lack of efficacy data and increased risk of adverse effects. The drug is primarily eliminated by the kidneys, and impaired renal function can lead to drug accumulation, potentially causing renal toxicity and worsening kidney function.

For this patient with osteoporosis and a history of breast cancer, alternative osteoporosis treatments should be considered, such as denosumab (Prolia), which does not have the same renal restrictions 1. However, any alternative treatment should be carefully selected considering her breast cancer history, and a nephrology consultation would be advisable before initiating any osteoporosis therapy given her renal impairment. It is also important to note that the use of bisphosphonates in patients with metastatic breast cancer has been studied, and zoledronic acid may be superior to pamidronate in lytic breast metastasis 1, but this patient's primary concern is osteoporosis, not metastatic bone disease.

Key considerations for alternative treatments include:

• Denosumab (Prolia) as a potential alternative to bisphosphonates, given its different mechanism of action and lack of renal restrictions 1
• Careful selection of treatment considering the patient's breast cancer history and renal impairment
• Nephrology consultation before initiating any osteoporosis therapy to ensure safe and effective treatment.

From the FDA Drug Label

Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min due to lack of experience with alendronate in renal failure 5.6 Renal Impairment Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min.

The patient's GFR is 31, which is less than 35 mL/min. Alendronate is contraindicated in this patient due to renal impairment 2, 2.

From the Research

Alendronate Contraindication in Osteoporosis Patient with Impaired Renal Function

• The patient in question is an 83-year-old female with osteoporosis, impaired renal function (GFR 31, creatinine 1.75), and a history of breast cancer.
• According to the studies, alendronate is not absolutely contraindicated in patients with impaired renal function, but its use requires careful consideration.
• A study from 2021 3 found that alendronate use in older patients with reduced renal function (creatinine clearance <35ml/min) was not associated with significant deterioration in renal function from baseline nor increased incidence of osteoporotic fractures or acute kidney injury.
• Another study from 2024 4 suggested that fracture incidence on alendronate was constant regardless of renal function, and that the incidence of vertebral fractures on teriparatide-alendronate was lower than alendronate monotherapy in patients with CKD 1/2.
• However, it is essential to note that the studies do not provide a clear consensus on the use of alendronate in patients with severe renal impairment (GFR <30).
• The decision to use alendronate in this patient should be based on a careful assessment of the benefits and risks, taking into account the patient's individual characteristics, including her history of breast cancer and impaired renal function.

Key Considerations

• Renal function: The patient's GFR is 31, which indicates severe renal impairment.
• Osteoporosis: The patient has osteoporosis, which increases her risk of fractures.
• Breast cancer history: The patient's history of breast cancer may affect her treatment options.
• Alendronate efficacy and safety: The studies suggest that alendronate can be effective in preventing fractures, but its use in patients with severe renal impairment requires careful consideration.

Treatment Options

• Alendronate: May be considered, but with careful monitoring of renal function and potential side effects.
• Other bisphosphonates: May be considered as alternatives to alendronate, depending on the patient's individual characteristics.
• Non-bisphosphonate treatments: May be considered, such as denosumab, which has been shown to improve glomerular filtration rate in osteoporotic patients with normal kidney function by lowering serum phosphorus 5.