Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2009 Jul;94(7):2495-501.
doi: 10.1210/jc.2009-0154. Epub 2009 Apr 28.

Effects of teriparatide retreatment in osteoporotic men and women

Joel S Finkelstein  1 , Jason J Wyland, Benjamin Z Leder, Sherri-Ann M Burnett-Bowie, Hang Lee, Harald Jüppner, Robert M Neer
Affiliations
Clinical Trial

Effects of teriparatide retreatment in osteoporotic men and women

Joel S Finkelstein et al. J Clin Endocrinol Metab. 2009 Jul.

Abstract

Context: The stimulatory effect of teriparatide on bone mineral density (BMD) and bone turnover is initially exuberant, but then diminishes.

Objective: Our objective was to determine whether retreating with teriparatide after a drug-free period can restore the initial exuberant response to teriparatide.

Design and setting: This was a planned extension of a randomized controlled trial conducted in a single university hospital.

Patients and intervention: Subjects previously participated in a 30-month randomized trial comparing the effects of alendronate (group 1), teriparatide (group 2), or both (group 3) on BMD and bone turnover in men and women with low BMD (phase 1). Subjects who completed phase 1 on their assigned therapy entered phase 2 (months 30-42), during which teriparatide was stopped in groups 2 and 3. Teriparatide was administered to all subjects during months 42 to 54 (phase 3).

Main outcome measures: We compared changes in BMD and markers of bone turnover (serum osteocalcin, N-terminal propeptide of type 1 collagen, and N-telopeptide) between phase 1 and 3 in subjects receiving teriparatide alone.

Results: Posterior-anterior and lateral spine BMD increased 12.5 +/- 1.5 and 16.9 +/- 1.7%, respectively, during the first 12 months of teriparatide administration and 5.2 +/- 0.8 and 6.2 +/- 1.8%, respectively, during teriparatide retreatment (P < 0.001 and P = 0.001). Increases in osteocalcin (P < 0.001), N-terminal propeptide of type 1 collagen (P < 0.001), and N-telopeptide (P < 0.001) were greater during the first period of teriparatide administration.

Conclusion: The response to teriparatide is attenuated when readministered after a 12-month hiatus.

Trial registration: ClinicalTrials.gov NCT00000400.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow of subjects through the protocol.
Figure 2
Figure 2
Diagram of the study protocol. ALN, Alendronate; TPT, teriparatide.
Figure 3
Figure 3
Change in BMD of the posterior-anterior spine, lateral spine, femoral neck, and radius shaft during initial teriparatide (TPT) treatment (months 6–30), TPT withdrawal (months 30–42), and TPT re-treatment (months 42–54). Periods being compared (months 6–18 and 42–54) are denoted by the blue shading and red horizontal lines. Data are presented as mean ± se.
Figure 4
Figure 4
Percentage change in posterior-anterior spine BMD in each subject during months 6 to 18 and months 42 to 54. The diagonal line is the line of identity.
Figure 5
Figure 5
Change in serum osteocalcin, P1NP, and N-telopeptide levels during initial teriparatide (TPT) treatment (months 6–30), TPT withdrawal (months 30–42), and TPT re-treatment (months 42–54). Periods being compared (months 6–18 and 42–54) are denoted by the blue shading and red horizontal lines. Data are presented as mean ± se.
See this image and copyright information in PMC

References

    1. Finkelstein JS 2000 Osteoporosis. In: Goldman L, Bennett JC, eds. Cecil textbook of medicine. 21st ed. Philadelphia: W.B. Saunders Company; 1366–1373
    1. Finkelstein JS, Klibanski A, Schaefer EH, Hornstein MD, Schiff I, Neer RM 1994 Parathyroid hormone for the prevention of bone loss induced by estrogen deficiency. N Engl J Med 331:1618–1623 - PubMed
    1. Finkelstein JS, Klibanski A, Arnold AL, Toth TL, Hornstein MD, Neer RM 1998 Prevention of estrogen deficiency-related bone loss with human parathyroid hormone-(1–34): a randomized, controlled trial. JAMA 280:1067–1073 - PubMed
    1. Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH 2001 Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441 - PubMed
    1. Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ 2003 The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med 349:1207–1215 - PubMed

Publication types

MeSH terms

Associated data