How many years should you take Prolia?
Prolia has been used safely for up to 8 years with a substantial increase in bone density in one phase 2 clinical trial, although most clinical trials are for 3 or 4 years.
Prolia needs to be taken long-term for it to work well at reducing fractures.
Does taking Prolia Injections longer improve my fracture risk?
Prolia reduces the number of new vertebral fractures in postmenopausal women, and the longer it is taken, the larger the decrease in the chance of vertebral fracture.
- In the first year, the Prolia group had 1.3% fewer fractures compared to the placebo group
- In the first 2 years, the Prolia group had 3.6% fewer fractures than the placebo group
- In the first 3 years, the Prolia group had 4.9% fewer fractures 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% |
Related questions
- What's the difference between Prolia and Reclast?
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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 that once Prolia injections stop, there is an increase in bone turnover and rapid bone resorption.
- When stopping Prolia, your healthcare professional may recommend that you 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 the 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/
Read next
Does Prolia cause weight gain?
Prolia (denosumab) has not been associated with weight gain in clinical studies. Prolia can cause peripheral edema (fluid retention) or swelling, and this may lead to weight gain in some people. Continue reading
Evenity vs Prolia: Which is right for you?
Evenity (romosozumab-aqqg) and Prolia (denosumab) are two injectable medications that help lower the risk of bone fracture.
Continue reading
Does Prolia increase bone density?
Prolia (denosumab) does increase bone density. Prolia works by targeting a molecule called RANKL that osteoclasts need to work. By stopping RANKL from binding to its receptor Prolia reduces bone breakdown, bone loss, bone pain, and other bone complications. BMD was increased by 8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck in trials that measured BMD after three years of treatment with Prolia. Continue reading
See also:
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