Can a male patient with osteoporosis secondary to hyperparathyroidism continue taking Prolia (denosumab) beyond 2 years?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Article Review Status
Submitted
Under Review
Approved

Last updated: February 8, 2025 • View editorial policy

From the Guidelines

Yes, a male patient with osteoporosis secondary to hyperparathyroidism can continue taking Prolia (denosumab) beyond 2 years.

Rationale

  • The evidence-based guidelines for the management of osteoporosis in men recommend denosumab as a second-line treatment for men at a high risk of fracture 1.
  • Denosumab has been shown to provide benefits in BMD accrual compared with placebo in randomized controlled trials of men with osteoporosis over 2 years of follow-up 2.
  • A 2023 meta-analysis demonstrated the benefits of denosumab for BMD at the lumbar spine, femoral neck, and total hip 2.
  • While the guidelines do not specifically address the duration of denosumab treatment, they do recommend monitoring adherence to anti-resorptive therapy using biochemical markers of bone turnover 1.
  • It is essential to continue treatment with denosumab beyond 2 years if the patient is responding well to the therapy and has a high risk of fracture, as the benefits of treatment outweigh the risks.

Key Considerations

  • Ensure the patient's vitamin D and calcium levels are replete, as recommended by the guidelines 1.
  • Monitor the patient's bone turnover markers to assess adherence to denosumab therapy 1, 2.
  • Consider the patient's overall risk of fracture and adjust the treatment plan accordingly, using tools such as FRAX to adjudicate the type of anti-osteoporosis treatment used 1.

From the Research

Denosumab Treatment for Osteoporosis

  • Denosumab is a potent antiresorptive medication used to treat osteoporosis, and its efficacy in reducing fracture risk has been demonstrated in various studies 3.
  • However, rebound effects after denosumab cessation, including loss of bone mineral density and increased risk of osteoporotic fractures, have been reported 4, 5.

Rebound Hypercalcemia

  • Rebound hypercalcemia is a less frequently reported phenomenon after denosumab discontinuation, which may pose a diagnostic challenge to physicians 5.
  • This condition has been observed in patients with parathyroid carcinoma and may be associated with autonomous tertiary hyperparathyroidism 5.
  • Treatment approaches for rebound hypercalcemia include bisphosphonates or re-administration of denosumab, while a watch and wait strategy may be sufficient in asymptomatic cases 5.

Denosumab Treatment Beyond 2 Years

  • There is limited evidence on the long-term use of denosumab beyond 2 years, but some studies suggest that it may be safe and effective in reducing fracture risk in patients with osteoporosis 3, 6.
  • A study on men with osteoporosis found that denosumab reduced the risk of hip fractures by 36% compared to those who stopped treatment after one administration 3.
  • Another study on patients with glucocorticoid-induced osteoporosis refractory to previous treatment found that denosumab significantly increased bone mineral density and reduced serum levels of bone turnover markers over a 24-month period 6.

Elevated Parathyroid Hormone Levels

  • Elevated parathyroid hormone (PTH) levels have been observed in older women treated with denosumab for osteoporosis, and increasing age is associated with PTH elevations in these patients 7.
  • However, in the absence of any pathology, continuation of denosumab may be safe in lowering fracture risk, but a larger study may be required to confirm this 7.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.