Risedronate for Osteoporosis: Recommended Use and Dosing
Risedronate is a first-line bisphosphonate for treating osteoporosis in both postmenopausal women and men, with standard dosing of 35 mg once weekly or 5 mg daily for treatment, and 35 mg weekly or 5 mg daily for prevention in postmenopausal women. 1
Approved Dosing Regimens
For Treatment of Established Osteoporosis
- 35 mg once weekly (standard treatment dose) 1
- 5 mg daily (alternative daily dosing) 1
- 75 mg on two consecutive days per month 1
- 150 mg once monthly 1
- 35 mg once weekly delayed-release formulation (Atelvia) for treatment only 1
For Prevention of Osteoporosis
- 35 mg once weekly or 5 mg daily in postmenopausal women 1
Clinical Indications and Patient Selection
Postmenopausal Women
Bisphosphonates including risedronate are recommended as first-line therapy, with selection based on patient preference. 1
Treatment is indicated for:
- Women with T-score ≤ -2.5 1
- Women with T-score between -1.0 and -2.5 who have 10-year risk of major osteoporotic fracture ≥20% or hip fracture risk ≥3% 1
- Women with prior low-trauma fracture, even without osteoporosis on DEXA 1
- Women with advanced osteopenia (T-score approaching -2.5) may benefit from risedronate, with 73% reduction in fragility fractures demonstrated in post-hoc analysis 1
Men with Osteoporosis
Oral bisphosphonates including risedronate should be recommended as first-line therapy for men with osteoporosis, similar to the approach in postmenopausal women. 1
- Risedronate monotherapy improved BMD at lumbar spine (mean difference 4.39%, 95% CI 3.46-5.31%), total hip (mean difference 2.46%, 95% CI 1.71-3.22%), and femoral neck (mean difference 1.95%, 95% CI 0.62-3.27%) 1
- These improvements exceed the surrogate threshold effect for fracture reduction 1
Special Populations Requiring Treatment
Patients with cancer treatment-induced bone loss should receive bisphosphonate therapy at higher bone density thresholds than standard recommendations. 1
This includes:
- Premenopausal women with chemotherapy-induced ovarian failure or suppression 1
- Postmenopausal women receiving aromatase inhibitors 1
- Men receiving androgen deprivation therapy 1
- Patients with chronic glucocorticoid use (≥3-6 months) 1, 2
For glucocorticoid-induced osteoporosis:
- Oral bisphosphonates are preferred first-line therapy for adults ≥40 years at moderate-to-high fracture risk 1
- Treatment recommended for patients on prednisone ≥5 mg/day for ≥3 months with T-score below -1 2
- Risedronate significantly reduces fracture incidence after 1 year in glucocorticoid-treated patients 2
Efficacy Data
Fracture Reduction
- Vertebral fracture risk reduced by 49-65% in postmenopausal women with established osteoporosis over 1-3 years 3, 4, 5
- Non-vertebral fracture risk reduced by up to 39% over 3 years 5
- Hip fracture risk reduced by 40-60% in elderly women with low bone density and clinical risk factors 3, 5
Bone Mineral Density Improvements
- Lumbar spine BMD increased by 3.1-4.49% at 1 year 6, 7
- Total hip and femoral neck BMD significantly improved compared to placebo 1, 7
- BMD improvements maintained at 24 months with continued treatment 7
Critical Contraindications and Precautions
Absolute Contraindications
- Abnormalities of the esophagus that delay esophageal emptying 1
- Inability to stand or sit upright for at least 30 minutes after dosing 1
- Severe renal impairment (creatinine clearance <30 mL/min) 6
- Hypocalcemia (must be corrected before initiating therapy) 1
Important Safety Considerations
Osteonecrosis of the jaw (ONJ) is a serious but rare complication requiring dental evaluation before initiating bisphosphonate therapy. 6
- Patients developing ONJ should receive care from an oral surgeon 6
- Consider discontinuation based on individual benefit/risk assessment 6
Atypical femoral fractures can occur with bisphosphonate use, typically presenting as prodromal thigh or groin pain. 6
- Patients with thigh or groin pain should be evaluated for incomplete femur fracture 6
- Assess contralateral limb in patients presenting with atypical fracture 6
- Consider interrupting therapy pending individual risk/benefit assessment 6
Severe musculoskeletal pain may develop from one day to several months after starting therapy. 6
- Most patients experience symptom relief after discontinuation 6
- Consider discontinuing if severe symptoms develop 6
Administration Guidelines
Standard Immediate-Release Formulation
- Administer at least 30 minutes before first food, beverage, or medication of the day 1
- Take with plain water only (6-8 oz) 1
- Patient must remain upright (sitting or standing) for at least 30 minutes after dosing 1
Delayed-Release Formulation (Atelvia)
- Administer immediately following breakfast 1, 6
- Administration before breakfast under fasting conditions resulted in significantly higher incidence of abdominal pain 6
Duration of Therapy
There appears to be a trend toward interrupting bisphosphonate therapy after 5-10 years, though optimal duration remains uncertain. 1
- Combination therapy with multiple osteoporosis medications is not recommended 1
- Consider drug holidays after 5-10 years based on individual fracture risk reassessment 1
Supplementation
Calcium (1000-1200 mg/day) and vitamin D (600-800 IU/day, serum level ≥20 ng/mL) should be added to risedronate therapy. 1
- Most bisphosphonate trials included calcium and vitamin D supplementation 1
- Dosages should be carefully monitored to avoid hypercalcemia 1
Common Pitfalls to Avoid
- Do not use in patients with creatinine clearance <30 mL/min due to lack of clinical experience 6
- Do not administer delayed-release formulation before breakfast as this significantly increases abdominal pain 6
- Do not overlook prodromal thigh/groin pain which may indicate impending atypical femoral fracture 6
- Ensure proper upright positioning for 30 minutes after immediate-release formulation to minimize esophageal adverse events 1, 6
- Screen for and correct hypocalcemia before initiating therapy 1