How long should someone be on Risedronate?

Duration of Risedronate Therapy for Osteoporosis

Treat osteoporotic patients with risedronate for 5 years initially, then reassess fracture risk to determine whether to continue, take a drug holiday, or discontinue treatment. 1

Initial Treatment Duration

The FDA label and clinical guidelines converge on a 5-year treatment period as the standard initial duration:

• For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use 2
• The American College of Physicians recommends treating osteoporotic women with pharmacologic therapy for 5 years 1
• Most studies evaluating bisphosphonate benefit continued therapy for up to 5 years 1

Reassessment After Initial Treatment Period

After the initial 5-year treatment course, clinical decision-making should be based on ongoing fracture risk:

For Low-Risk Patients:

• Consider discontinuation after 5 years if bone mineral density is stable and no fractures have occurred 3
• Patients at low fracture risk should be considered for drug discontinuation after 3 to 5 years 2
• All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis 2

For High-Risk Patients:

• Continue treatment up to 10 years for patients at high fracture risk 3
• Continuing treatment after the initial 5 years may be beneficial for some patients after reassessing risks and benefits 1
• After 10 years, consider a drug holiday of no more than 1-2 years, potentially with non-bisphosphonate treatment during that interval 3

Rationale for Drug Holidays

The pharmacokinetic properties of risedronate support periodic treatment interruption:

• Risedronate has a long terminal half-life of 480 hours, creating a bone reservoir that provides continued release for months or years after discontinuation 3, 4
• Studies suggest persisting antifracture efficacy for 1-2 years after stopping treatment following 3-5 years of therapy 3
• Sustained antifracture effect has been demonstrated through 5 years and suggested through 7 years of continuous treatment 3

Special Populations

Cancer Treatment-Induced Bone Loss:

• For patients on androgen deprivation therapy or aromatase inhibitors, treatment duration follows similar principles: initial 5-year course with reassessment 1
• Six-monthly dosing regimens are used for the duration of endocrine treatment or up to 5 years 1

Glucocorticoid-Induced Osteoporosis:

• Treatment should continue as long as glucocorticoid therapy continues, with periodic reassessment 1

Monitoring During Treatment

Do not perform bone density monitoring during the initial 5-year treatment period 1

• Moderate-quality evidence shows women benefit from reduced fractures with antiresorptive treatment even if BMD does not increase or decreases 1
• Current evidence does not support BMD monitoring during treatment 1

Common Pitfalls to Avoid

• Do not abruptly discontinue without reassessing fracture risk, as this may leave high-risk patients unprotected 1
• Avoid indefinite continuation without periodic reassessment, as rare adverse effects (osteonecrosis of the jaw, atypical femoral fractures) increase with prolonged use 3
• Do not use FRAX scores alone to guide continuation decisions, as evidence linking FRAX to treatment efficacy during therapy is lacking 1

The risk of severe adverse effects increases with prolonged bisphosphonate use, making the balance of benefits and harms most favorable when treatment duration is matched to fracture risk 1