Forsteo ® (teriparatid)

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Forsteo® (teriparatide): Användning efter annan osteoporosbehandling

Patienter som tidigare behandlats med ett antiresorptiva medel som bytte till teriparatid uppvisade förbättringar i benmineraltäthet och benomsättningsmarkörer i kliniska prövningar.

Clinical Trials on Switching From Antiresorptives to Teriparatide

Anabolics After Antiresorptives Study

In the prospective, open-label, nonrandomized AAA study, patients previously treated with alendronate (n=33) or raloxifene (n=26) for 18 to 36 months were switched to teriparatide.1

Primary and secondary endpoints after 12 months of follow-up included change in

  • LS and TH BMD

  • BTMs, and

  • safety.1

Changes in LS (p<.05) and TH (p<.05) BMD were significant in patients previously treated with raloxifene. Changes in LS (p<.05) BMD were significant in patients previously treated with alendronate while total hip BMD was not.1

At month 12 follow-up, BTMs exhibited rapid, significant changes from baseline during teriparatide treatment in both the alendronate (p<.05) and raloxifene (p<.05) pretreatment groups.1

Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide (OPTAMISE) Study

OPTAMISE was an open-label, multinational, nonrandomized, parallel-group study.2

Postmenopausal women previously treated with alendronate (n=146) or risedronate (n=146) for at least 24 months were switched to teriparatide for 12 months. Upon enrollment in the study, patients discontinued their current therapy and started on teriparatide with not more than a 1- or 2-week hiatus between cessation and initiation.2

During treatment with teriparatide, compared to the alendronate pretreated group, those previously treated with risedronate had significantly greater changes in

  • BTMs from months 1 to 5 (p<.05), and

  • areal and trabecular spine volumetric BMD (p<.05).2

Clinical Trials Using Teriparatide in Treatment Naïve vs Prior Antiresorptive Treated Patients

European Study of Forsteo

Secondary Analysis Based on Prior Antiresorptive Treatment

A secondary analysis of the 24-month, prospective, open-label, randomized trial conducted in a subset of 245 PMW with established osteoporosis investigated BMD changes stratified by prior antiresorptive treatment.3

Patients were stratified to

  • alendronate (n=107)

  • risedronate (n=59)

  • etidronate (n=30), or

  • non-bisphosphonate (n=49).3

In 6-month increments over 24 months, LS and TH BMD were measured, and bone formation markers were measured at months 1 and 6.3

Changes in LS BMD from baseline were significant in all subgroups at each 6-month time point (p<.05).3

Changes in TH and FN BMD were significant in all subgroups at 24 months (p<.05).3

After month 1, all subgroups experienced a significant increase in bone formation marker levels from baseline. After 6 months, bone formation marker levels were significantly greater in the prior risedronate group compared with the prior alendronate (p<.01) and non-bisphosphonate groups (p<.05).3

Analysis Based on Response to Antiresorptive

In a separate analysis based on the EUROFORS study, 503 women either treatment naïve or treated with antiresorptives, stratified as either inadequate or adequate, were randomized to teriparatide. Patients were grouped as

  • treatment naïve (n=84)

  • antiresorptive pretreated (n=134), and

  • inadequate antiresorptive responders (n=285).4

LS, TH, and FN BMD were measured in 6-month increments over 24 months. Overall, the BMD increases were greatest in previously treatment naïve patients (Table 1).4

Table 1. Mean Percent Increase in Bone Mineral Density from Baseline to 24 Months According to Prior Antiresorptive Treatment or Response to Antiresorptive Treatment4

Group (n)

Skeletal Site

LS

TH

FN

Treatment-naïve (84)

13.1%a

3.8%a

4.8%a

Adequate response (134)

10.2%ab

2.3%a

3.4%a

Inadequate response (285)

9.8%ac

2.3%ad

3.9%a

Abbreviations: FN = femoral neck; LS = lumbar spine; TH = total hip.

a p<0.001 vs baseline.

b p<0.01 vs treatment-naïve.

c p<0.001 vs treatment-naïve.

d p<0.05 vs treatment-naïve.

References

1. Ettinger B, Martin SJ, Crans G, Pavo I. Differential effects of teriparatide on BMD after treatment with raloxifene or alendronate. J Bone Miner Res. 2004;19(5):745-751. http://dx.doi.org/10.1359/JBMR.040117

2. Miller PD, Delmas PD, Lindsay R, et al. Early responsiveness of women with osteoporosis to teriparatide after therapy with alendronate or risedronate. J Clin Endocrinol Metab. 2008;93(10):3785-3793. http://dx.doi.org/10.1210/jc.2008-0353

3. Boonen S, Marin F, Obermayer-Pietsch B, et al; EUROFORS Investigators. Effects of previous antiresorptive therapy on the bone mineral density response to two years of teriparatide treatment in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2008;93(3):852-860. http://dx.doi.org/10.1210/jc.2007-0711

4. Obermayer-Pietsch BM, Marin F, McCloskey EV, et al. Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment. J Bone Miner Res. 2008;23(10):1591-1600. http://dx.doi.org/10.1359/jbmr.080506

Glossary

AAA = Anabolics After Antiresorptives

BMD = bone mineral density

BTM = bone turnover marker

EUROFORS = European Study of Forsteo

FN = femoral neck

LS = lumbar spine

PMW = postmenopausal women

TH = total hip

Datum fӧr senaste ӧversyn 2020 M03 16

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