Treatment responses with once-weekly teriparatide therapy for osteoporosis

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Abstract

Summary

Monitoring bone mineral density is useful to assess treatment response for osteoporosis, but it does not always reflect fracture prevention. Two types of bone mineral density thresholds were used to analyze data from a once-weekly teriparatide trial, and they appear to be useful indicators of treatment success for osteoporosis.

Introduction

This study aimed to clarify whether the criteria of treatment response could be used to evaluate treatment success with once-weekly teriparatide.

Methods

The data of subjects whose lumbar or femoral neck bone mineral density (BMD) was measured in the TOWER study were included. The least significant change (LSC) and the absolute change were used as the criteria for judgment of treatment success. The correlation between the incidence of fractures and the treatment response was also assessed.

Results

There was no significant difference in baseline characteristics between the placebo and teriparatide groups. Once-weekly teriparatide therapy for 72 weeks showed treatment success in 79.2 % of the subjects for lumbar BMD and 44.1 % for femoral neck BMD by LSC and in 50.5 and 39.6 % by absolute change, respectively. A lower incidence of vertebral fracture was observed in patients who achieved treatment success for lumbar BMD. With the LSC, some treatment success was observed in the early phase of treatment, and it increased with treatment duration.

Conclusions

It appears that the LSC could be used as a surrogate efficacy indicator at an earlier stage of treatment, and the absolute criterion of −2.5SD was confirmed as a useful marker of long-term treatment success.

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Most cited references 16

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Diagnosis of osteoporosis and assessment of fracture risk.

John Kanis (2002)

The diagnosis of osteoporosis centres on the assessment of bone mineral density (BMD). Osteoporosis is defined as a BMD 2.5 SD or more below the average value for premenopausal women (T score < -2.5 SD). Severe osteoporosis denotes osteoporosis in the presence of one or more fragility fractures. The same absolute value for BMD used in women can be used in men. The recommended site for diagnosis is the proximal femur with dual energy X-ray absorptiometry (DXA). Other sites and validated techniques, however, can be used for fracture prediction. Although hip fracture prediction with BMD alone is at least as good as blood pressure readings to predict stroke, the predictive value of BMD can be enhanced by use of other factors, such as biochemical indices of bone resorption and clinical risk factors. Clinical risk factors that contribute to fracture risk independently of BMD include age, previous fragility fracture, premature menopause, a family history of hip fracture, and the use of oral corticosteroids. In the absence of validated population screening strategies, a case finding strategy is recommended based on the finding of risk factors. Treatment should be considered in individuals subsequently shown to have a high fracture risk. Because of the many techniques available for fracture risk assessment, the 10-year probability of fracture is the desirable measurement to determine intervention thresholds. Many treatments can be provided cost-effectively to men and women if hip fracture probability over 10 years ranges from 2% to 10% dependent on age.

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Comparison of semiquantitative visual and quantitative morphometric assessment of prevalent and incident vertebral fractures in osteoporosis The Study of Osteoporotic Fractures Research Group.

M Nevitt, L. Palermo, H Genant … (1996)

The assessment of radiographs for vertebral fractures is important in the clinical evaluation of patients with suspected osteoporosis, in the epidemiological evaluation of elderly populations, and in clinical trials of osteotrophic drugs. The purpose of this study is to compare visual semiquantitative (SQ) approaches and quantitative morphometric approaches for assessing prevalent and incident vertebral fractures in postmenopausal osteoporosis. We analyzed lateral thoracolumbar spine radiographs (baseline and approximately 3.5 year follow-up) of 503 women (age > or = 65) randomly selected from the Study of Osteoporotic Fractures (SOF) population. SQ assessment by an experienced radiologist graded vertebral fractures from 0 (normal) to 3 (severe). Incident fractures by SQ were defined as an increase of > or = 1 grade on follow-up radiographs. Trained research assistants visually triaged women as normal, uncertain, or probably fractured and visually flagged vertebrae with moderate/severe (grade > or = 2) prevalent fractures or with any (grade > or = 1 change) incident fracture. The radiographs were also digitized by research assistants, and quantitative morphometry (QM) was used to classify vertebral deformities at several cut-offs based on standard deviation (SD) reductions in height ratios from normal means, e.g., QM > or = 3 SD. Incident fractures by QM were defined as a decrease in height of more than 15% (QM15) on follow-up radiographs. Finally, a combination of these methods was used to detect moderate/severe prevalent fractures and any grade of incident fractures. In the overall analysis, the prevalence of fractures varied from 14 to 33% and the incidence from 5 to 10% by woman, depending upon the method and cut-off criteria. In the detailed analysis, considering visually triaged uncertain as abnormal, triage by research assistants detected 97.0% (163/168) of women with SQ grade > or = 1 fractures and 100% (70/70) with SQ grade > or = 2 fractures. Visual flagging by research assistants detected 88.5% (108/122) of SQ > or = 2 prevalent fractures (kappa score, kappa = 0.82) and 85.2% (52/61) of SQ incident fractures (kappa = 0.79). QM > or = 3 SD detected 37.9% (141/372) of SQ > or = 1 prevalent fractures (kappa = 0.51) and 79.5% (97/122) of SQ > or = 2 prevalent fractures (kappa = 0.68), plus 18 vertebrae without SQ fractures. QM 15 detected 59% (36/61) of SQ incident fractures (kappa = 0.70), plus five vertebrae without SQ incident fractures. The combination assessment detected 92% (112/122) of SQ > or = 2 prevalent fractures (kappa = 0.76) and 84% (51/61) of SQ incident fractures (kappa = 0.91). The precision errors of QM vertebral height measurements (baseline versus follow-up) ranged from 2.71 to 2.92%. Nevertheless, excluding the 5719 vertebrae that were clearly normal by morphometry, i.e., within 2 SD of the normal means at both baseline and follow-up, two-thirds (358/556) of the remaining vertebrae changed classification by at least 1 SD category. Visual triage and visual flagging by research assistants appear to be highly effective methods for vertebral fracture assessment in osteoporosis, potentially reducing the number of false-positive and false-negative fractures detected by QM, at least relative to SQ by the radiologists. There is higher concordance among the visual approaches studied than between the visual SQ and quantitative morphometric approaches, with QM having limited ability to detect mild fractures but good ability to detect moderate/severe fractures, as classified by SQ. Use of a combination of sensitive qualitative and quantitative criteria, with adjudication by an experienced radiologist, is feasible and draws upon the relative strengths of each of the methods. Quantitative morphometry should not be performed in isolation, particularly when applying highly sensitive morphometric criteria at low threshold levels, without visual assessment to confirm the detected prevalent or incident vertebral defor

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Randomized Teriparatide [human parathyroid hormone (PTH) 1-34] Once-Weekly Efficacy Research (TOWER) trial for examining the reduction in new vertebral fractures in subjects with primary osteoporosis and high fracture risk.

Teruki Sone, Yoshiki Nishizawa, Hiroshi Hagino … (2012)

Weekly teriparatide injection at a dose of 56.5 μg has been shown to increase bone mineral density. A phase 3 study was conducted to determine the efficacy of once-weekly teriparatide injection for reducing the incidence of vertebral fractures in patients with osteoporosis. In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed. Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture. Subjects were randomly assigned to receive once-weekly s.c. injections of teriparatide (56.5 μg) or placebo for 72 wk. The primary endpoint was the incidence of new vertebral fracture. Once-weekly injections of teriparatide reduced the risk of new vertebral fracture with a cumulative incidence of 3.1% in the teriparatide group, compared with 14.5% in the placebo group (P < 0.01), and a relative risk of 0.20 (95% confidence interval, 0.09 to 0.45). At 72 wk, teriparatide administration increased bone mineral density by 6.4, 3.0, and 2.3% at the lumbar spine, the total hip, and the femoral neck, respectively, compared with the placebo (P < 0.01). Adverse events (AE) and the dropout rates by AE were more frequently experienced in the teriparatide group, but AE were generally mild and tolerable. Weekly s.c. administration of teriparatide at a dose of 56.5 μg may provide another option of anabolic treatments in patients with osteoporosis at higher fracture risk.

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Author and article information

Contributors

M. Shiraki: +81-263-77-2134 , +81-263-77-6963 , shikari_m@icloud.com

Journal

Journal ID (nlm-ta): Osteoporos Int

Journal ID (iso-abbrev): Osteoporos Int

Title: Osteoporosis International

Publisher: Springer London (London )

ISSN (Print): 0937-941X

ISSN (Electronic): 1433-2965

Publication date (Electronic): 27 May 2016

Publication date PMC-release: 27 May 2016

Publication date (Print): 2016

Volume: 27

Issue: 10

Pages: 3057-3062

Affiliations

[1 ]Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, 1610-1 Meisei, Misato, Azumino, Nagano 399-8101 Japan

[2 ]Medical Affairs Department, Asahi Kasei Pharma Corporation, 1-105 Kanda, Jinbocho, Chiyoda-ku, Tokyo, 101-8101 Japan

[3 ]Internal Medicine 1, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo, Shimane 693-8501 Japan

[4 ]National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655 Japan

Article

Publisher ID: 3640

DOI: 10.1007/s00198-016-3640-5

PMC ID: 5042992

PubMed ID: 27234671

SO-VID: 5bea4d88-a1d5-4f07-ad00-632960864c89

License:

Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

History

Date received : 2 December 2015

Date accepted : 13 May 2016

Funding

Funded by: Asahi Kasei Pharma Corporation

Custom metadata

ScienceOpen disciplines: Orthopedics

Keywords: bone mineral density,incident fracture,teriparatide,treatment success

Data availability:

ScienceOpen disciplines: Orthopedics

Keywords: bone mineral density, incident fracture, teriparatide, treatment success

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Treatment responses with once-weekly teriparatide therapy for osteoporosis

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Abstract

Summary

Introduction

Methods

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Conclusions

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Orthopedics

Most cited references 16

Diagnosis of osteoporosis and assessment of fracture risk.

Comparison of semiquantitative visual and quantitative morphometric assessment of prevalent and incident vertebral fractures in osteoporosis The Study of Osteoporotic Fractures Research Group.

Randomized Teriparatide [human parathyroid hormone (PTH) 1-34] Once-Weekly Efficacy Research (TOWER) trial for examining the reduction in new vertebral fractures in subjects with primary osteoporosis and high fracture risk.

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