Prolia (Preservative Free)

Only for patients established on Prolia (denosumab) therapy.

To increase bone mass in postmenopausal females with osteoporosis who meet the following criteria:

- High risk* for fracture; and

- Failed other available osteoporosis therapy (i.e. fragility fracture OR evidence of a decline in bone mineral density below pre-treatment baseline levels) despite adherence for one year.

*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.

Only for patients established on Prolia (denosumab) therapy.

To increase bone mass in postmenopausal females with osteoporosis who meet the following criteria:

- High risk* for fracture; and

- For whom oral bisphosphonates are contraindicated due to hypersensitivity OR 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.

Only for patients established on Prolia (denosumab) therapy.

To increase bone mass in males with osteoporosis who meet the following criteria:

- High risk* for fracture; and

- Failed other available osteoporosis therapy (i.e. fragility fracture OR evidence of a decline in bone mineral density below pre-treatment baseline levels) despite adherence for one year.

*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.

Only for patients established on Prolia (denosumab) therapy.

To increase bone mass in males with osteoporosis who meet the following criteria:

- High risk* for fracture; and

- For whom oral bisphosphonates are contraindicated due to hypersensitivity OR 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 increase bone mass in postmenopausal women with osteoporosis at high risk for fracture; increase bone mass in men with osteoprosis at high risk for fracture.

Patients must meet the following criteria:

- Patients who require palliative care during the transition period of November 29, 2024, to August 29, 2025.