Forsteo® (teriparatid): Osteoporosmedicinering efter Teriparatide

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