From the Guidelines
The typical duration of a drug holiday from alendronate (bisphosphonate) therapy is after 5 years of treatment, with consideration for stopping unless the patient has a strong indication for treatment continuation. When considering a drug holiday, several factors should be taken into account, including the patient's risk of fracture, bone density, and history of prior fractures.
- Patients at lower risk of fracture may be able to stop treatment after 5 years,
- while those at higher risk may need to continue therapy without interruption or take a shorter holiday. This approach is based on current evidence suggesting that increasing the duration of bisphosphonate therapy to longer than 3 to 5 years reduces risk for new vertebral fractures but not risk for other fractures, and is associated with increased risk for long-term harms 1. During the drug holiday period, bone mineral density should be monitored, and treatment should be resumed if there is significant bone loss, a fracture occurs, or high-risk factors develop. Adequate calcium and vitamin D intake should also be maintained during this period to support bone health, as recommended by current clinical guidelines 1. The decision to stop or continue bisphosphonate treatment should be individualized, taking into account the patient's specific risk factors and medical history.
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.
The typical duration of a drug holiday from alendronate therapy is 3 to 5 years of use, after which patients at low-risk for fracture should be considered for drug discontinuation 2.
- Key points:
- Re-evaluation: The need for continued therapy should be re-evaluated on a periodic basis.
- Discontinuation: Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
From the Research
Duration of Drug Holiday from Alendronate
The typical duration of a drug holiday from alendronate therapy can vary depending on several factors, including the patient's fracture risk, bone mineral density, and overall health.
- A drug holiday of two to three years is recommended for most patients after long-term bisphosphonate therapy, including alendronate 3.
- The optimal length of a drug holiday has not been established, but existing data suggest up to 5 years with alendronate 4.
- Discontinuation of alendronate beyond 2 years was associated with increased risk of hip, humerus, and clinical vertebral fractures 5.
- A study suggested that 3-5 years for alendronate can be recommended as a drug holiday duration, after which the patient should be reassessed 6.
Factors Influencing Drug Holiday Duration
Several factors can influence the duration of a drug holiday from alendronate, including:
- Total bisphosphonate exposure 3
- Type of bisphosphonate used 3, 6
- Bone mineral density and falls risk 3, 4
- Patient sex and body weight 3
- Fracture risk, with patients at high risk potentially requiring longer treatment durations 6, 4
Reassessment and Treatment Resumption
After a drug holiday, patients should be reassessed to determine if treatment should be resumed.