When should a patient with osteoporosis stop taking Actonel (risedronate)?

When to Stop Actonel (Risedronate) in Osteoporosis

Clinicians should consider stopping Actonel after 5 years of treatment in patients who do not have strong indications for continuation, as this represents the standard treatment duration supported by clinical trial evidence. 1, 2

Standard Treatment Duration

• The American College of Physicians strongly recommends 5 years as the standard bisphosphonate treatment duration for osteoporotic patients. 1, 2
• Most clinical trials demonstrating fracture reduction efficacy with risedronate continued therapy for 3-5 years, with some extension studies showing maintained benefits through 7 years. 1, 3, 4
• Evidence shows that extending treatment beyond 5 years probably reduces vertebral fractures but not other fracture types, while increasing the risk of long-term harms. 1

Risk Stratification for Continuation vs. Drug Holiday

Patients Who Should STOP After 5 Years:

• No previous hip or vertebral fractures during treatment 2
• Hip BMD T-score > -2.5 after treatment 2
• Low to moderate fracture risk without multiple risk factors 1, 2
• Age <80 years without glucocorticoid use 2

Patients Who Should CONTINUE Beyond 5 Years:

• Previous hip or vertebral fractures (even while on treatment) 2
• Multiple non-spine fractures 2
• Hip BMD T-score ≤ -2.5 despite treatment 2
• Age >80 years 2
• Ongoing glucocorticoid use (≥7.5 mg/day prednisone equivalent) 1
• Very high FRAX scores or multiple risk factors for fracture 2

Critical Considerations for Drug Holidays

• The decision to stop should be based on baseline fracture risk, medication type and half-life, duration of treatment, and balance of benefits versus harms. 1, 2
• Risedronate has a shorter bone half-life compared to alendronate or zoledronic acid, meaning its effects dissipate more quickly after discontinuation. 3, 5
• After stopping risedronate, bone turnover markers increase but remain below pre-treatment baseline for up to 2 years, and hip BMD decreases by approximately 1.6% over 2 years. 5

Monitoring During and After Treatment

• Do NOT perform routine BMD monitoring during the initial 5-year treatment period, as fracture reduction occurs even without BMD increases. 1, 2
• During a drug holiday, reassess patients every 1-2 years for new fractures, changes in fracture risk profile, and BMD changes (particularly femoral neck T-score). 1, 2
• Resume risedronate if: a new fracture occurs during the holiday, fracture risk increases significantly, or BMD remains low (femoral neck T-score ≤ -2.5). 2

Common Pitfalls to Avoid

• Never automatically continue bisphosphonates beyond 5 years without reassessing fracture risk, as this exposes patients to unnecessary rare adverse events (osteonecrosis of the jaw, atypical femoral fractures) without proven additional benefit in low-risk individuals. 2, 6
• Ensure dental work is completed before continuing therapy beyond 5 years to reduce osteonecrosis of the jaw risk, which increases with duration of bisphosphonate exposure. 2, 6
• Maintain adequate calcium (1000-1200 mg/day) and vitamin D (800 IU/day) intake both during and after risedronate therapy, as deficiency reduces treatment efficacy and increases fracture risk. 1, 7, 6
• Address poor adherence proactively, as gaps in treatment are common (30% of patients who stop for 60+ days restart within 6 months), and the effectiveness of interrupted bisphosphonate use is unknown. 8

Special Warnings from FDA Label

• Upper gastrointestinal adverse reactions (esophagitis, ulcers, erosions) can occur; discontinue if patients develop dysphagia, odynophagia, retrosternal pain, or new/worsening heartburn. 6
• Hypocalcemia must be corrected prior to use and monitored during treatment. 6
• Severe bone, joint, and muscle pain may occur (onset from 1 day to several months); consider discontinuing if severe symptoms develop. 6
• Atypical femoral fractures have been reported; evaluate patients with new thigh or groin pain to rule out femoral fracture. 6

Alternative Considerations

• Do NOT switch to denosumab as a routine alternative after 5 years of risedronate, as denosumab discontinuation carries serious risk of rebound vertebral fractures and requires immediate bisphosphonate therapy within 6 months if stopped. 2
• If patients were initially treated with anabolic agents (teriparatide, romosozumab), they must receive an antiresorptive agent like risedronate after discontinuation to preserve gains and prevent rebound fractures. 1, 2