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How many years should you take Prolia?

Medically reviewed by Melisa Puckey, BPharm. Last updated on March 22, 2022.

Official answer

by Drugs.com

How long can I stay on Prolia for?

For Prolia to work well at reducing fractures it needs to be taken long term and in one phase 2 clinical trial it has been used safely for up to 8 years with substantial increase in bone density, although most clinical trials are for 3 or 4 years.

Does taking Prolia Injections longer improve my fracture risk?

Prolia reduces the number of new vertebral fracture in postmenopausal women and the longer it is taken shows there is a bigger decrease in chance of vertibral fracture.

  • In the first year the Prolia group has 1.3% less fractures compared to the placebo group
  • In the first 2 years the Prolia group has 3.6% less fractures than placebo group
  • In the first 3 years the Prolia group has 4.9% less fracture than the placebo group

Percentage of Women with Fractures

Treatment Time Prolia Group Placebo Group

Difference Between Groups

0 - 1 year 0.9% 2.2% 1.3%
0 - 2 years 1.4% 5.0% 3.6%
0 - 3 years 2.3% 7.2% 4.9%

When should I stop Prolia?

It is important that you should NOT stop Prolia without discussing this with your healthcare professional.

  • Stopping Prolia can cause an increase in the number of multiple vertebral fractures often within a year of stopping.
  • The reason for this is once Prolia injections stop there is an increase in bone turnover and rapid bone resorption.
  • When stopping Prolia your healthcare profession may recommend you to take another osteoporosis medicine to prevent the increased risk of multiple vertebral fractures, due to the rebound increase in bone turnover.

Bottom Line:

  • There is no recommended time of treatment for Prolia Injections, clinical studies have often been three years and at least one study went for 8 years.
  • The longer you take Prolia Injection the bigger the improvement in fracture risk when compared to placebo.
  • Stopping Prolia injections can cause a rebound increase in bone turnover which increases risk of multiple vertebral fractures.
  • Do not stop taking Prolia injections without first discussing this with your prescribing health professional.
References
  • Prolia Professional Medication Information: https://www.drugs.com/pro/prolia.html
  • Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3536967/
  • Spontaneous vertebral fractures after denosumab discontinuation: A case collection and review of the literature: https://pubmed.ncbi.nlm.nih.gov/30826108/
  • Fracture risk and management of discontinuation of denosumab therapy: a systematic review and position statement by ECTS: https://pubmed.ncbi.nlm.nih.gov/33103722/
  • Warning of an Increased Risk of Vertebral Fracture after Stopping Denosumab: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5915244/

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