From the Guidelines
Patients with osteopenia who have been on alendronate for 3-5 years should be considered for a drug holiday, with the duration of the holiday individualized based on their fracture risk. The decision to discontinue alendronate when bones have improved from osteoporosis to osteopenia involves weighing the benefits of continued treatment against the potential risks, such as atypical femur fractures and osteonecrosis of the jaw, which increase with longer duration of therapy 1. For patients who initially had osteoporosis but now have osteopenia and have been on alendronate for 5 years or more, a drug holiday of 2-3 years is often recommended, with bone density monitoring every 1-2 years during this period. Key factors to consider when deciding on the duration of the drug holiday include:
- Fracture risk: Patients at higher fracture risk (previous fractures, older age, multiple risk factors) may benefit from shorter holidays or continued treatment 1.
- Bone density: Regular monitoring of bone density is crucial to assess the need for continued therapy or resumption of treatment 1.
- Clinical risk factors: A comprehensive evaluation of clinical risk factors, such as family history, lifestyle, and comorbidities, should be performed when considering resumption of therapy 1. Alendronate has a long half-life in bone tissue, providing residual protective effects even after discontinuation, which supports the feasibility of a drug holiday approach 1.
From the FDA Drug Label
The optimal duration of use has not been determined. The safety and effectiveness of alendronate sodium for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Discontinuation of alendronate in patients with osteopenia should be considered on a case-by-case basis.
- Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use.
- The need for continued therapy should be re-evaluated on a periodic basis.
- Risk for fracture should be re-evaluated periodically in patients who discontinue therapy 2.
From the Research
Duration of Alendronate Treatment for Osteopenia
- The provided studies do not directly address the duration of alendronate treatment for patients with osteopenia who were previously taking the medication 3, 4, 5, 6, 7.
- However, it is mentioned that osteopenia does not in itself constitute a treatment imperative, and treatment is usually considered for patients with low energy fracture(s) or very high risk for future fracture 6.
- The studies suggest that alendronate can be effective in maintaining bone mineral density (BMD) gains after denosumab treatment is discontinued 4, and that it can be used as an alternative to other treatments such as risedronate 5.
- The decision to stop or continue alendronate treatment should be based on individual patient risk factors and fracture risk assessment, rather than solely on the presence of osteopenia 6, 7.
- There is no specific guidance on the duration of alendronate treatment for patients with osteopenia, and the treatment plan should be determined on a case-by-case basis, taking into account the patient's overall health and fracture risk 3, 4, 5, 6, 7.