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  4. How does temporary interruption or abrupt withdrawal affect Forsteo® (teriparatide) treatment?
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Forsteo ® (teriparatide)

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How does temporary interruption or abrupt withdrawal affect Forsteo® (teriparatide) treatment?

Eli Lilly and Company has not identified any safety concerns associated with temporary interruption or abrupt withdrawal of teriparatide for treatment of osteoporosis. The effects of stopping and restarting teriparatide on its efficacy are not known.

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Adverse events following temporary interruption or abrupt stopping of treatment

Eli Lilly and Company (Lilly) has not identified any safety concerns, including adverse reactions or side effects, associated with temporary interruption or abrupt withdrawal of teriparatide therapy for the treatment of osteoporosis during our clinical studies or follow-up analyses.1-6

Effect of stopping and restarting teriparatide on the efficacy of treatment of osteoporosis

The recommended treatment time is 24 months.7

However, teriparatide was studied in once-a-day administration without interruption. Therefore, no data are available on interruption of therapy in patients receiving less than 24 months of treatment. It is not known what effect stopping and restarting teriparatide may have on the efficacy of the medication.

References

1Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344(19):1434-1441. http://dx.doi.org/10.1056/nejm200105103441904

2Orwoll ES, Scheele WH, Paul S, et al. The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. J Bone Miner Res. 2003;18(1):9-17. https://dx.doi.org/10.1359/jbmr.2003.18.1.9

3Lindsay R, Scheele WH, Neer R, et al. Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. Arch Intern Med. 2004;164(18):2024-2030. http://dx.doi.org/10.1001/archinte.164.18.2024

4Saag KG, Shane E, Boonen S, et al. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007;357(20):2028-2039. http://dx.doi.org/10.1056/NEJMoa071408

5Silverman S, Miller P, Sebba A, et al. The direct assessment of nonvertebral fractures in community experience (DANCE) study: 2-year nonvertebral fragility fracture results. Osteoporos Int. 2013;24(8):2309-2317. https://dx.doi.org/10.1007/s00198-013-2284-y

6Saag KG, Zanchetta JR, Devogelaer JP, et al. Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six–month results of a randomized, double-blind, controlled trial. Arthritis Rheum. 2009;60(11):3346-3355. https://doi.org/10.1002/art.24879

7Forsteo [package leaflet]. Eli Lilly Nederland B.V., The Netherlands.

Date of Last Review: 30 June 2023

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