Alternative to Prolia Treatment | Osteoporosis | Amgen

PROLIA® TREATMENT SHOULD NOT BE STOPPED WITHOUT CONSIDERING ALTERNATIVE THERAPEUTIC OPTIONS1

Prolia® treatment is associated with continuous increases in BMD and sustained low incidence of vertebral, non-vertebral and hip fractures for up to 10 years of continuous therapy.2
The effects of Prolia® are reversible3 and treatment should not be stopped, without considering other anti-resorptive therapies.1
Percentage change in BMD over a month for lumber spine, total hip and one-third distal radius.
Data are percentage changes in BMD over 48 months, presented as least-squares means (95% confidence intervals) based on repeated measures models that adjust for treatment, strata, visit, baseline value, densitometer type, treatment-by-visit interaction, and baseline value-by-densitometer type interaction. Patients with a lumbar spine BMD T-score between -1.0 and -2.5 were eligible to participate in the study, Prolia® was discontinued at 24 months.3
*p≤0.0071.
After Prolia® discontinuation, the incidence of new vertebral fractures was higher than in patients who remained on treatment, but similar to the risk in patients who had never been treated. Multiple vertebral fractures may occur following discontinuation of treatment with Prolia®, particularly in patients with a history of vertebral fracture.4,5
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Prolia® on an individual patient basis, particularly after 5 or more years of use.6
Prolia® treatment should not be stopped without considering alternative therapeutic options. ECTS recommends that patients at high risk of fracture should continue therapy for up to 10 years. For patients at low risk, a decision to discontinue Prolia® after 5 years can be made, but bisphosphonate therapy should be considered to maintain accrued bone mass.1
Patients at high risk of fracture:1
  • Older age
  • Low hip BMD T-score or high fracture risk score
  • Previous major osteoporotic fractures
  • Fracture(s) on therapy
Find out more about the ECTS recommendations here.
Advise your patients not to discontinue Prolia® therapy without a physician’s advice. It is important to evaluate the individual benefit/risk before discontinuing treatment with Prolia®.
Click here to learn about developments in treat-to-target approaches to the management of osteoporosis.
Cases of ONJ have been observed in patients receiving anti-resorptive therapies, including Prolia®.2,6–9

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The risk of developing ONJ in patients with osteoporosis receiving anti-resorptive treatment is estimated as slightly higher, if at all, than the risk of ONJ in the general population who have not received anti-resorptive therapy.8
ONJ is associated with invasive OPEs, but few patients with OPEs subsequently developed ONJ in the FREEDOM extension study.10
AMG_ONJ CFE_Total ONJ cases
Patients with the following risk factors may have an increased risk of ONJ:6,8
AMG_ONJ CFE_ONJ risk factors
Preventive measures can help to minimize the risk of ONJ when taking anti-resorptive therapies6,8,10
AMG_ONJ CFE_Recommendations
Patients with osteoporosis receiving an anti-resorptive may continue with therapy if a routine dental procedure is required. Careful considerations of the risks and benefits is necessary if there are any concerns around ONJ.10
During treatment with Prolia®, all patients should be encouraged to immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores, or discharge.6

References:
BMD: bone mineral density; ECTS: European Calcified Tissue Society; ONJ: osteonecrosis of the jaw; OPEs: oral procedures and events.
  1. Tsourdi E, et al. Bone. 2017;105:11–7.
  2. Bone HG, et al. Lancet Diabetes Endocrinol. 2017;5:513–23.
  3. Bone HG, et al. J Clin Endocrinol Metab. 2011;96:972–80.
  4. Brown, et al. J Bone Miner Res. 2013;28:746–52.
  5. Cummings SR, et al. J Bone Miner Res. 2018;33:190–8.
  6. Prolia® (denosumab) Summary of Product Characteristics. Amgen. Last revised February 2020.
  7. Ruggiero SL, et al. J Oncol Pract. 2006;2:7–14.
  8. Khan AA, et al. J Clin Densitom. 2017;20:8–24.
  9. Ruggiero SL, et al. J Oral Maxillofac Surg. 2014;72:1938–56.
  10. Watts NB, et al. J Clin Endocrinol Metab. 2019 [online]; doi.org/10.1210/jc.2018-01965.

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