From the Guidelines
Bisphosphonate therapy should be continued for up to 2 years, with less-frequent dosing considered in patients with responsive or stable disease, and resumed upon relapse with new-onset skeletal-related events. The recommended duration of bisphosphonate therapy is based on the latest guidelines from the American Society of Clinical Oncology, which suggest that bone-targeting treatment continue for a period of up to 2 years 1.
Key Considerations
- The Expert Panel recommends that serum creatinine should be monitored before each dose of pamidronate or zoledronic acid, in accordance with US Food and Drug Administration (FDA)–approved labeling 1.
- Denosumab does not require monitoring of renal function, but its use should not be stopped abruptly due to its reversible mechanism of action 1.
- Patients should be calcium and vitamin D repleted, and serum calcium should be monitored regularly, with serum vitamin D levels evaluated intermittently 1.
Monitoring and Maintenance
- The Expert Panel recommends intermittent evaluation—every 3 to 6 months—of all patients receiving pamidronate or zoledronic acid therapy for the presence of albuminuria on a spot urine sample 1.
- In patients who experience unexplained albuminuria, a 24-hour urine collection should be obtained to assess for . 500 mg/24 hours of urinary albumin, and discontinuation of the drug is advised until renal problems are resolved 1.
- Patients should receive a comprehensive dental examination and appropriate preventive dentistry before bone-modifying therapy, and active oral infections should be treated, with sites that are at high risk for infection eliminated 1.
Treatment Duration and Reassessment
- For patients who do not have active myeloma and are on maintenance therapy, the physician may consider a 3-month interval of bisphosphonate administration 1.
- There are no data to support a more precise recommendation for the duration of bisphosphonate therapy in this group of patients, and treatment duration should be individualized based on a risk–benefit ratio and the severity of bone disease 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. Limitations of UseOptimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use
The recommended duration of bisphosphonate therapy is not explicitly stated, but it is suggested that patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use 2 3.
- Key points:
- The optimal duration of use has not been determined.
- Patients on bisphosphonate therapy should have their need for continued therapy re-evaluated periodically.
- Discontinuation should be considered for patients at low-risk for fracture after 3 to 5 years of use.
From the Research
Recommended Duration of Bisphosphonate Therapy
The recommended duration of bisphosphonate therapy for patients with osteoporosis varies depending on several factors, including the type of bisphosphonate used, patient response to treatment, and fracture risk.
- Discontinuation of bisphosphonates should be considered in patients who have been treated for more than five years with alendronate, risedronate, or zoledronic acid 4.
- For patients who have not experienced fractures before or during therapy and have a low fracture risk, a "drug holiday" can be recommended, with suggested durations of:
- After the drug holiday, patients should be reassessed, and treatment resumed if a new fracture is experienced, fracture risk has increased, or bone mineral density (BMD) remains low (femoral neck T-score ≤-2.5) 4, 5.
- A narrative review suggests that a drug holiday of two to three years is recommended for most patients after long-term bisphosphonate therapy, considering the continued fracture protection and potential for rare adverse events associated with long-term use 6.
Factors Influencing Treatment Duration
Several factors can influence the duration of bisphosphonate therapy, including:
- Total bisphosphonate exposure 6
- Type of bisphosphonate used 6
- Bone mineral density and falls risk 6
- Patient sex and body weight 6
- Patient response to treatment and fracture risk 4, 5
Clinical Considerations
Clinical studies have shown that long-term use of bisphosphonates results in persistent antifracture and BMD-increasing effects beyond 3 years of treatment, with no unexpected adverse events identified 5.
- BMD monitoring and fracture risk assessments should be conducted regularly to determine whether treatment could be stopped or should be reinitiated 5.
- Treatment decisions should be based on anti-fracture efficacy data, as well as individual patient conditions affecting compliance and persistence, and patient preferences 7.