What routine investigations should a patient on Prolia (denosumab) undergo annually?

From the Guidelines

Patients on Prolia (denosumab) should undergo routine annual investigations, including a comprehensive metabolic panel, serum calcium levels, vitamin D levels, and a bone mineral density (BMD) test every 1-2 years, as well as dental examinations and fracture risk assessments. These investigations are crucial to monitor the effectiveness of denosumab and identify potential side effects, such as hypocalcemia, and ensure the medication is effectively increasing bone density and reducing fracture risk 1. Key annual investigations for patients on denosumab include:

• Comprehensive metabolic panel to assess kidney and liver function
• Serum calcium levels to monitor for hypocalcemia
• Vitamin D levels to ensure adequacy
• Bone mineral density (BMD) test every 1-2 years to evaluate treatment effectiveness
• Complete blood count to monitor for potential hematological effects
• Dental examinations to assess the risk of osteonecrosis of the jaw
• Fracture risk assessments to evaluate the effectiveness of treatment Additionally, patients should be assessed for any new fractures or height loss during their annual visits, and their fracture risk should be reassessed annually 1. It is also essential to correct vitamin D deficiency and provide vitamin D supplementation with adequate intake of calcium throughout treatment to maintain normal serum calcium levels 1. Monitoring of creatinine clearance is required to guide dosing of zoledronic acid, but denosumab may be administered to patients with impaired renal function or even patients on hemodialysis, with careful monitoring of serum calcium levels 1. Overall, these routine annual investigations are essential to ensure the safe and effective use of denosumab in patients with bone metastases.

From the FDA Drug Label

A routine oral exam should be performed by the prescriber prior to initiation of Prolia treatment. Monitor serum calcium weekly for the first month after Prolia administration and monthly thereafter The routine investigations that should be done annually for a patient on Prolia include:

• Serum calcium and mineral levels (phosphorus and magnesium): Although the label does not specify annual monitoring, it does recommend monitoring serum calcium weekly for the first month and monthly thereafter.
• Routine oral exam: The label recommends a routine oral exam prior to initiation of treatment, but it can be implied that regular dental check-ups are necessary to monitor for Osteonecrosis of the Jaw (ONJ). It is also recommended to:
• Assess bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present, although the frequency of this assessment is not specified.
• Instruct patients to report new or unusual thigh, hip, or groin pain to rule out atypical femoral fractures 2.

From the Research

Routine Investigations for Patients on Prolia (Denosumab)

Patients on Prolia (denosumab) require regular monitoring to assess the effectiveness of treatment and potential side effects. The following investigations should be considered on an annual basis:

• Bone mineral density (BMD) measurements to assess changes in bone density 3, 4
• Laboratory tests, including:
  • Serum calcium and phosphate levels to monitor for hypocalcemia 5, 6
  • Alkaline phosphatase (ALP) and parathyroid hormone (PTH) levels to assess bone turnover 5, 6
  • Creatinine levels to monitor renal function 5
  • 25-hydroxyvitamin D levels to assess vitamin D status 5
• Monitoring for potential side effects, such as:
  • Osteonecrosis of the jaw (ONJ) 7, 3
  • Atypical femoral fracture (AFF) 7, 3
  • Severe renal failure 7

Additional Considerations

• Patients on denosumab should be educated on the importance of regular monitoring and the potential risks associated with treatment 7, 3
• Healthcare providers should be aware of the potential for rebound effects after discontinuation of denosumab and take steps to mitigate these effects 7, 3