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Risedronate Sodium (Actonel)
Risedronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption by binding to hydroxyapatite on the bone surface and blocking farnesyl pyrophosphate synthase in the mevalonate pathway.
Risedronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption by binding to hydroxyapatite on the bone surface and blocking farnesyl pyrophosphate synthase in the mevalonate pathway. Used for Postmenopausal osteoporosis (treatment and prevention), Glucocorticoid-induced osteoporosis, Paget's disease of bone.
At a glance
| Generic name | Risedronate Sodium (Actonel) |
|---|---|
| Sponsor | Sanofi |
| Drug class | Bisphosphonate |
| Target | Farnesyl pyrophosphate synthase (indirect); hydroxyapatite binding |
| Modality | Small molecule |
| Therapeutic area | Bone metabolism / Osteoporosis |
| Phase | FDA-approved |
Mechanism of action
Bisphosphonates like risedronate are taken up by osteoclasts during bone resorption and inhibit the enzyme farnesyl pyrophosphate synthase, disrupting the mevalonate pathway essential for osteoclast function and survival. This leads to decreased bone turnover and increased bone mineral density. The drug is particularly effective at reducing vertebral and hip fracture risk in osteoporosis by slowing bone loss.
Approved indications
- Postmenopausal osteoporosis (treatment and prevention)
- Glucocorticoid-induced osteoporosis
- Paget's disease of bone
- Osteoporosis in men
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, abdominal pain)
- Headache
- Musculoskeletal pain
- Diarrhea
- Osteonecrosis of the jaw (rare)
- Atypical femoral fractures (rare)
Key clinical trials
- Camrelizumab Plus Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study on Mechanisms and Efficacy (PHASE2)
- Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery (PHASE3)
- Effects of Bisphosphonates on OI-Related Hearing Loss (PHASE4)
- Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis (NA)
- Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women (PHASE4)
- Denosumab Safety Assessment in Multiple Observational Databases
- A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907) (PHASE3)
- A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Risedronate Sodium (Actonel) CI brief — competitive landscape report
- Risedronate Sodium (Actonel) updates RSS · CI watch RSS
- Sanofi portfolio CI