For the treatment of Paget's disease.

For the treatment of osteoporosis in postmenopausal females who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - a prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR - a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR - where a patient's 10-year fracture risk based on the CAROC or FRAX tool, is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors.

For the treatment of osteoporosis in males who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - a moderate 10-year fracture risk (10% to 20%) with a prior fragility fracture based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR - a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR - where the patient's 10-year fracture risk is below 10% based on the CAROC or FRAX tool, a high fracture risk based on evaluation of clinical risk factors for fracture Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors. In all cases, patients receiving Aclasta should not be receiving concomitant bisphosphonate therapy. The recommended dose of Aclasta (zoledronic acid) is a single IV injection of 5mg, once yearly.