Risedronate for Osteoporosis Treatment
Risedronate is an effective and safe oral bisphosphonate for treating osteoporosis, with strong evidence showing reduction in vertebral fractures and improvement in bone mineral density. 1, 2
Efficacy of Risedronate
- Risedronate is FDA-approved for the prevention and treatment of postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, and Paget's disease of bone 1, 2
- Clinical studies demonstrate that risedronate increases bone mineral density (BMD) and decreases fracture incidence compared to placebo in patients with postmenopausal osteoporosis 1, 3
- Risedronate reduces the risk of vertebral fractures by up to 49% and non-vertebral fractures by up to 39% over 3 years in postmenopausal women with one or more prevalent vertebral fractures 3
- The reduction in vertebral fracture risk is significant from the first year of treatment (risk reduction up to 65%) 3, 4
- In patients with glucocorticoid-induced osteoporosis, risedronate has been shown to increase BMD with positive effects on vertebral fractures within the first year 3
Dosing Options
- Standard dosing is 5 mg daily or 35 mg once weekly 2, 5
- A 150 mg once-monthly formulation has been shown to be equally effective as the 5 mg daily regimen in increasing lumbar spine BMD and is well-tolerated 5
- The once-monthly regimen may provide a convenient alternative for patients who prefer less frequent dosing 5
Safety Profile
- Risedronate has a safety profile comparable to placebo in clinical studies 3, 4
- The upper gastrointestinal (GI) safety profile of risedronate is similar to placebo in endoscopic studies 3
- Risedronate appears to have better gastrointestinal tolerability than alendronate and may be preferred for patients with GI concerns 1
- No evidence of acute-phase reactions or primary mineralization defects has been observed 3, 4
Treatment Recommendations Based on Risk
- For adults ≥40 years with high or very high fracture risk, oral bisphosphonates like risedronate are strongly recommended over no treatment 6
- For adults with moderate fracture risk, bisphosphonates including risedronate are conditionally recommended 6
- For adults receiving high-dose glucocorticoids (initial dose ≥30 mg/day for >30 days or cumulative dose ≥5 g in 1 year), oral bisphosphonates are strongly recommended over no treatment 6
- For adults <40 years with moderate fracture risk, oral or IV bisphosphonates are conditionally recommended 6
Comparison with Other Treatments
- In glucocorticoid-induced osteoporosis, risedronate appears to be less effective than alendronate but more effective than etidronate in terms of effects on BMD and/or fracture risk 1
- In Paget's disease, risedronate has been reported to be more effective than etidronate in decreasing serum alkaline phosphatase levels and bone pain 1, 4
- For patients at very high fracture risk, PTH/PTHrP agonists are conditionally recommended over anti-resorptives like risedronate 6
- For patients at high fracture risk, PTH/PTHrP or denosumab are conditionally recommended over bisphosphonates 6
Duration of Therapy
- The optimal duration of bisphosphonate use has not been determined 7
- All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated periodically 7
- Patients at low risk for fracture should be considered for drug discontinuation after 3 to 5 years of use 7
- Patients who discontinue therapy should have their risk for fracture re-evaluated periodically 7
Important Considerations and Monitoring
- Optimize dietary and supplemental calcium and vitamin D intake in addition to bisphosphonate therapy 6
- Follow-up BMD with vertebral fracture assessment or spinal x-ray every 1-2 years during treatment 8
- Contraindications to oral bisphosphonates include esophageal abnormalities, inability to stand/sit upright, hypocalcemia, and chronic kidney disease with GFR < 35 ml/min/1.73 m² 8
- Risedronate should be taken on an empty stomach at least 30 minutes before breakfast for optimal absorption 5