Forsteo ® (teriparatid)

För fullständig produktresumé för Forsteo® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Forsteo® (teriparatid): Osteoporosmedicinering efter Teriparatide

Efter avslutad behandling med Forsteo kan patienterna fortsätta på andra osteoporosbehandlingar. Kliniska studier har utvärderat användningen av osteoporos läkemedel, inklusive bisfosfonater och raloxifen efter utsättande av teriparatid.

Bisphosphonates Therapy after Teriparatide

Bisphosphonates after Discontinuation of Teriparatide in the Fracture Prevention Trial

Follow-up studies to the Fracture Prevention Trial evaluated the impact of bisphosphonate therapy or no treatment after discontinuation of teriparatide on

  • bone mineral density (BMD)1,2,

  • vertebral fracture1, and

  • nonvertebral fragility fracture2.

The LS, FN, and TH BMD was preserved to a greater extent in women who received bisphosphonate therapy compared to no treatment after discontinuation of teriparatide.1,2

Logistic regression analysis did not show that bisphosphonate use enhanced the ability of prior teriparatide therapy to prevent VFs following withdrawal of teriparatide (OR 0.97, 95% CI 0.58-1.62, p=.91).1

Due to the design of the follow-up period, the effect of bisphosphonate therapy after discontinuation of teriparatide on nonvertebral fragility fracture risk was not evaluated.2

Zoledronic acid after Discontinuation of Teriparatide

A clinical study evaluated the effect of a single infusion of zoledronic acid to maintain the gains in bone mass achieved after 2 years of teriparatide treatment in 33 postmenopausal women (PMW) with osteoporosis.3

At the 12-month follow-up, more patients experienced either stable BMD or a significant increase in BMD than a significant decrease in BMD (significant change defined as ±0.030 g/cm2) at all sites: LS, TH, FN, and total body.3

Raloxifene Therapy After Teriparatide

Two prospective, open-label, randomized studies evaluated the effect of raloxifene therapy on BMD after discontinuation of teriparatide in PMW with osteoporosis.4,5

Study 1

In the study conducted by Adami et al., 329 women who completed 1-year of teriparatide treatment were randomized to receive either raloxifene 60 mg daily or placebo for 1-year.4

Compared to the placebo group, patients who received raloxifene had significantly

  • smaller decreases in LS BMD (-1 % raloxifene vs -4% placebo; p<.001), and

  • greater increases in FN BMD (2.3 % raloxifene vs .02% placebo, p<.001).4

Study 2

In the EUROFORS Sub-study, 507 PMW with osteoporosis who completed 1-year of teriparatide therapy were randomized to receive teriparatide, raloxifene, or placebo for 1-year.5

Compared to the placebo group, patients who received teriparatide or raloxifene had significantly

  • greater increases in LS BMD (p<.001 for both), and

  • greater increases in TH BMD (p<.001 for teriparatide and p <.05 for raloxifene).5

References

1. Lindsay 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

2. Prince R, Sipos A, Hossain A, et al. Sustained nonvertebral fragility fracture risk reduction after discontinuation of teriparatide treatment. J Bone Miner Res. 2005;20(9):1507-1513. http://dx.doi.org/10.1359/JBMR.050501

3. Tuthill K, Deal C, Kriegman A. Bone loss after discontinuation of teriparatide can be prevented with a single infusion of zoledronic acid [abstract FR0351]. J Bone Miner Res. 2009;24(suppl 1):S137. http://dx.doi.org/10.1002/jbmr.5650241302

4. Adami S, San Martin J, Muñoz-Torres M, et al. Effect of raloxifene after recombinant teriparatide [hPTH(1-34)] treatment in postmenopausal women with osteoporosis. Osteoporos Int. 2008;19(1):87-94. http://dx.doi.org/10.1007/s00198-007-0485-y

5. Eastell R, Nickelsen T, Marin F, et al. Sequential treatment of severe postmenopausal osteoporosis following teriparatide: final results of the randomized, controlled European Study of Forsteo (EUROFORS). J Bone Miner Res. 2009;24(4):726-736. http://dx.doi.org/10.1359/jbmr.081215

Glossary

BMD = bone mineral density

EUROFORS = European Study of Forsteo

FN = femoral neck

LS = lumbar spine

NVFX = nonvertebral fragility fracture

PMW = postmenopausal women

TH = total hip

VF = vertebral fracture

Datum fӧr senaste ӧversyn 2020 M03 09


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