Actonel (Risedronate) Dosing for Osteoporosis
For postmenopausal women with osteoporosis, risedronate 35 mg once weekly (taken at least 30 minutes before breakfast or as delayed-release immediately after breakfast) or 150 mg once monthly are the recommended dosing regimens, with the 5 mg daily dose being an alternative option. 1
Standard Dosing Regimens
Weekly Dosing
- Risedronate 35 mg once weekly is the most commonly used regimen for treatment of postmenopausal osteoporosis 1, 2
- The immediate-release formulation must be taken at least 30 minutes before breakfast with plain water 1
- A delayed-release formulation (35 mg) can be taken immediately after breakfast, providing greater convenience 1, 3
- Both formulations demonstrate equivalent efficacy in increasing lumbar spine BMD (approximately 4-5% over 2 years) 2, 3
Monthly Dosing Options
- Risedronate 150 mg once monthly provides similar efficacy and safety to daily dosing 4
- An alternative monthly regimen is 75 mg on two consecutive days each month, which showed non-inferior efficacy to daily dosing 5
- Monthly dosing may improve adherence for patients who prefer less frequent administration 4
Daily Dosing
- Risedronate 5 mg daily taken at least 30 minutes before breakfast remains an effective option 1, 2
- This was the original approved dose based on fracture reduction trials 1
Treatment Duration
The American College of Physicians recommends treating osteoporotic women with pharmacologic therapy for 5 years. 6
- Most efficacy studies evaluated treatment for up to 5 years 6
- Continuing treatment beyond 5 years may be appropriate after reassessing individual risk-benefit profiles 6
- BMD monitoring during the initial 5-year treatment period is not recommended 6
Supplementation Requirements
All patients on risedronate must receive adequate calcium and vitamin D supplementation. 1
- Calcium: 1000 mg daily 1, 2
- Vitamin D: 800-1000 IU daily if baseline 25-hydroxyvitamin D levels are adequate 1, 2
- Patients with vitamin D deficiency (25-hydroxyvitamin D <30 ng/mL) should receive correction before or concurrent with bisphosphonate initiation 7
Special Populations
Men with Osteoporosis
- Risedronate is recommended for men with clinically recognized osteoporosis, though this is a weak recommendation based on low-quality evidence 6
- The same dosing regimens used in postmenopausal women apply 1
Glucocorticoid-Induced Osteoporosis
- For adults ≥40 years at moderate-to-high fracture risk on chronic glucocorticoids, oral bisphosphonates (including risedronate) are strongly recommended 6
- Standard osteoporosis dosing regimens are used 6
Renal Impairment
- Risedronate is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min) due to lack of clinical experience 1
- Oral bisphosphonates have better renal safety than IV formulations in patients with reduced kidney function 7
Contraindications and Precautions
Risedronate is contraindicated in patients with: 1
- Esophageal abnormalities that delay esophageal emptying
- Inability to stand or sit upright for at least 30 minutes
- Hypocalcemia (must be corrected before initiating therapy)
- Hypersensitivity to any component
Important Safety Considerations
- Risk of osteonecrosis of the jaw, particularly with dental procedures or poor oral hygiene 6, 1
- Atypical subtrochanteric and diaphyseal femoral fractures with long-term use 1
- Upper gastrointestinal adverse events (esophagitis, gastritis, ulcers) 6, 1
- Severe musculoskeletal pain may occur; consider discontinuation if symptoms are incapacitating 1
Administration Instructions
For Immediate-Release Formulations
- Take at least 30 minutes before the first food, beverage, or medication of the day 1
- Swallow whole with 6-8 ounces of plain water only (not mineral water) 1
- Remain upright (sitting or standing) for at least 30 minutes after taking 1
For Delayed-Release Formulation
- Can be taken immediately after breakfast 1, 3
- Still requires remaining upright for at least 30 minutes 1
- This formulation contains EDTA and enteric coating to improve absorption when taken with food 8
Comparative Efficacy
Risedronate, along with alendronate, zoledronic acid, and denosumab, reduces the risk of hip, vertebral, and nonvertebral fractures in women with osteoporosis. 6