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Randomized Controlled Trial
. 2011 Jun;22(6):1935-46.
doi: 10.1007/s00198-010-1379-y. Epub 2010 Oct 12.

Early changes in biochemical markers of bone turnover and their relationship with bone mineral density changes after 24 months of treatment with teriparatide

A Blumsohn  1 , F Marin, T Nickelsen, K Brixen, G Sigurdsson, J González de la Vera, S Boonen, S Liu-Léage, C Barker, R Eastell; EUROFORS Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Early changes in biochemical markers of bone turnover and their relationship with bone mineral density changes after 24 months of treatment with teriparatide

A Blumsohn et al. Osteoporos Int. 2011 Jun.

Abstract

We report the changes in biochemical markers of bone formation during the first 6 months of teriparatide therapy in postmenopausal women with osteoporosis according to previous antiresorptive treatment. Prior therapy does not adversely affect the response to teriparatide treatment. Similar bone markers levels are reached after 6 months of treatment.

Introduction: The response of biochemical markers of bone turnover with teriparatide therapy in subjects who have previously received osteoporosis drugs is not fully elucidated. We examined biochemical markers of bone formation in women with osteoporosis treated with teriparatide and determined: (1) whether the response is associated with prior osteoporosis therapy, (2) which marker shows the best performance for detecting a response to therapy, and (3) the correlations between early changes in bone markers and subsequent bone mineral density (BMD) changes after 24 months of teriparatide.

Methods: We conducted a prospective, open-label, 24-month study at 95 centers in 10 countries in 758 postmenopausal women with established osteoporosis (n = 181 treatment-naïve) who had at least one post-baseline bone marker determination. Teriparatide (20 μg/day) was administered for up to 24 months. We measured procollagen type I N-terminal propeptide (PINP), bone-specific alkaline phosphatase (b-ALP), and total alkaline phosphatase (t-ALP) at baseline, 1 and 6 months, and change in BMD at the lumbar spine, total hip and femoral neck from baseline to 24 months.

Results: Significant increases in formation markers occurred after 1 month of teriparatide regardless of prior osteoporosis therapy. The absolute increase at 1 month was lower in previously treated versus treatment-naïve patients, but after 6 months all groups reached similar levels. PINP showed the best signal-to-noise ratio. Baseline PINP correlated positively and significantly with BMD response at 24 months.

Conclusions: This study suggests that the long-term responsiveness of bone formation markers to teriparatide is not affected in subjects previously treated with antiresorptive drugs.

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Figures

Fig. 1
Fig. 1
Patient disposition
Fig. 2
Fig. 2
Percentage change from baseline of the bone markers (a) PINP, (b) b-ALP, and (c) t-ALP after 1 and 6 months of teriparatide treatment in the treatment naïve, AR pretreated and inadequate AR responder subgroups
See this image and copyright information in PMC

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