1 Adverse Reaction Overview Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis, esophageal ulcer and gastric ulcer. It is therefore important to follow the recommended dosing instructions. 4 Administration.
Musculoskeletal pain, rarely severe, has been reported as a common adverse event in patients who received risedronate sodium for all indications and dosage forms. In risedronate sodium osteoporosis studies, the most commonly reported adverse reactions were abdominal pain, dyspepsia and nausea.
In addition, diarrhea was the most commonly reported adverse reaction for the highest risedronate sodium monthly dose. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real- world use. Treatment and Prevention of Postmenopausal Osteoporosis: risedronate sodium 5 mg daily has been studied for up to 3 years in over 5000 women enrolled in Phase III clinical trials for treatment or prevention of postmenopausal osteoporosis.
Most adverse events reported in these trials were either mild or moderate in severity, and did not lead to discontinuation from the study. The distribution of severe adverse events was similar across treatment groups. In addition, the overall incidence of adverse events (AEs) was found to be comparable amongst risedronate sodium and placebo-treated patients.
Table 2 lists adverse events considered possibly or probably drug-related, reported in ≥ 1% of risedronate sodium 5 mg daily-treated patients, in Phase III postmenopausal osteoporosis trials. 0% of patients treated with placebo. 5 * Considered to be possibly or probably causally related by clinical study Investigators.
Weekly Dosing:
In the 1-year, double-blind, multicentre study comparing risedronate sodium 35 mg Once-a-Week to risedronate sodium 5 mg daily for the treatment of osteoporosis in postmenopausal women, the overall safety and tolerability profiles of the 2 oral dosing regimens were similar.
The proportion of patients who experienced an upper gastrointestinal adverse event and the pattern of those events were found to be similar between the risedronate sodium 35 mg Once- a-Week and risedronate sodium 5 mg daily-treated groups.
3%) was reported in ≥ 1% of patients and in more risedronate sodium 35 mg weekly treated patients than in risedronate sodium 5 mg daily treated patients. In the 1-year, double-blind, multicentre study comparing risedronate sodium 35 mg Once-a- Week to placebo for the prevention of osteoporosis in postmenopausal women, the overall safety and tolerability profiles of the two groups were comparable with the exception of arthralgia.
7% of placebo patients. The overall safety profile observed in this study showed no substantive difference from that observed in the risedronate sodium 5 mg daily versus risedronate sodium 35 mg Once-a-Week treatment study. _____________________________________________________________________________________________ Risedronate (risedronate sodium) Page 12 of 40 Treatment of Osteoporosis in Men, to Improve Bone Mineral Density: In a 2-year, double- blind, multicentre study using risedronate sodium 35 mg Once-a-Week (n=191) and placebo (n=93) in men with osteoporosis, the overall safety and tolerability profiles of the two treatment groups were similar.
The proportion of patients who experienced an upper gastrointestinal adverse event and the pattern of those events were higher in placebo (18%) than in risedronate sodium 35 mg Once- a-Week treated patients (8%). In addition to the previously described adverse events, the following adverse events were reported in ≥ 2% of patients and in more risedronate sodium - treated patients than placebo- treated patients in the male osteoporosis study (events are included without attribution of causality): hypoaesthesia (risedronate sodium 35 mg, 2%; placebo, 1%), nephrolithiasis (risedronate sodium 35 mg, 3%; placebo, 0%), benign prostatic hyperplasia (risedronate sodium 35 mg, 5%; placebo, 3%) and arrhythmia (risedronate sodium 35 mg, 2%; placebo, 0%).
Endoscopic Findings:
Risedronate sodium 5 mg daily clinical studies enrolled over 5700 patients for the treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis, many with pre-existing gastrointestinal disease and concomitant use of NSAIDs or ASA.
Investigators were encouraged to perform endoscopies in any patients with moderate-to- severe gastrointestinal complaints while maintaining the blind. These endoscopies were ultimately performed on equal numbers of patients between the treated and placebo groups […]