24-Month Open-Label Teriparatide Once-Weekly Efficacy Research Trial Examining Bone Mineral Density in Subjects with Primary Osteoporosis and High Fracture Risk

Sugimoto, Toshitsugu; Shiraki, Masataka; Fukunaga, Masao; Hagino, Hiroshi; Sone, Toshio; Nakano, Tetsuo; Kishimoto, Hiroyuki; Ito, Masako; Yoshikawa, Hideki; Kishida, Mitsukazu; Irie, Chika; Nakamura, Toshio

doi:10.1007/s12325-017-0568-x

Cited by 17 publications

(12 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Significant improvements were observed in both the lumbar spine and the femur; as with the effect on BMD in the efficacy analysis, the improvement was not inferior to existing reports [1,10].…”

Section: Discussionsupporting

confidence: 41%

Impact of patient background factors on the treatment efficacy of once-weekly teriparatide

Omura¹

2019

Osteoporosis and Sarcopenia

View full text Add to dashboard Cite

Objectives The impact of patient background factors on changes in bone mineral density (BMD) and bone metabolic markers after treatment with once-weekly teriparatide (W-TPTD) has not been fully elucidated. To clarify the impact, I performed stratified analysis in addition to the efficacy and safety assessments to analyze treatment data with W-TPTD. Methods The primary endpoint of the efficacy was the rate of change of the lumbar spine BMD at 18 months after treatment. In the exploratory analysis, bone metabolic markers at baseline were used to divide the patients into 3 groups, by the first tertile and the second tertile. The rate of change in the lumbar spine/femoral neck BMD and bone metabolic markers in each group were analyzed by stratification. Results The rate of change in the lumbar spine BMD at 18 months was 9.0%, which represented a significant increase. The rate of change in the lumbar spine/femoral neck BMD in each group classified into tertiles by their baseline bone metabolic markers significantly increased, regardless of the type of bone metabolic markers and baseline value. For markers, all groups remained within the range of reference values at 18 months after treatment. Conclusions I demonstrated that W-TPTD significantly increased the BMD of the lumbar spine and femur, regardless of baseline values of the bone metabolic markers. In addition, W-TPTD was able to normalize bone metabolic markers. I considered that W-TPTD would be useful, independent of bone metabolic markers in patients, as an agent to improve BMD, and be a useful option for the treatment of osteoporosis.

show abstract

Section: Discussionsupporting

confidence: 41%

Impact of patient background factors on the treatment efficacy of once-weekly teriparatide

Omura¹

2019

Osteoporosis and Sarcopenia

View full text Add to dashboard Cite

show abstract

“…A non-clinical study showed that teriparatide administered at low frequencies only increased bone formation, rather than both bone formation and resorption, thereby showing a potential for avoiding cortical porosity [9, 22]. A 104-week clinical study of the 56.5-μg once-weekly regimen confirmed a significant increase in BMD at the radial distal 1/10 site and an increasing trend in BMD at the distal 1/3 and 1/6 sites, which are rich in cortical bone, which suggested that the 56.5-μg once-weekly regimen may have achieved the increase in radial BMD by avoiding cortical porosity [8]. Thus, the 28.2-μg twice-weekly regimen is expected to increase BMD substantially while maintaining these characteristics without cortical porosity of the 56.5-μg once-weekly regimen.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the regimen has also been shown to increase bone mineral density (BMD) substantially [7]. Another clinical study also reported that the 56.5-μg once-weekly regimen promotes bone formation without increasing bone resorption, showing a characteristic pattern of bone turnover, and it increases BMD of the radius, which is rich in cortical bone [8]. In addition, a non-clinical study showed that the once-weekly regimen of teriparatide is unlikely to induce histologic changes such as cortical porosity [9].…”

Section: Introductionmentioning

confidence: 99%

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study

Sugimoto

Shiraki²,

Fukunaga

et al. 2019

Osteoporos Int

Self Cite

View full text Add to dashboard Cite

SummaryA 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety.IntroductionWhile a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety.MethodsA 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2–L4) bone mineral density (BMD) at final follow-up.ResultsThe percentage changes in lumbar spine (L2–L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400–2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (− 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.ConclusionsA 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety.Clinical trial registrationJapicCTI-163477.Electronic supplementary materialThe online version of this article (10.1007/s00198-019-05111-6) contains supplementary material, which is available to authorized users.

show abstract

“…Recently, Sugimoto et al. [ 6 ] reported that a significant increase was observed in BMD at the 1/10 radius site at 24 and 104 weeks after initiation of once-weekly teriparatide. Sugimoto's report was part of a clinical trial for an approval application, while our clinical trial was the result of actual medical treatment.…”

Section: Discussionmentioning

confidence: 99%

Utility of radius bone densitometry for the treatment of osteoporosis with once-weekly teriparatide therapy

Nakayama

Toho

Sone

2018

Osteoporosis and Sarcopenia

Self Cite

View full text Add to dashboard Cite

ObjectivesAs clinics that treat patients with osteoporosis do not usually have central dual-energy X-ray absorptiometry (DXA), bone density is often measured with radial DXA. However, no long-term evidence exists for radius bone density outcomes following treatment with once-weekly teriparatide in actual medical treatment.MethodsWe evaluated changes in bone density at 6-, 12-, and 18-month intervals using radial DXA in patients treated with once-weekly teriparatide for more than 6 months.ResultsA significant increase in bone mineral density (BMD) was observed at the 1/3 and 1/10 radius sites 12 months after the initiation of once-weekly teriparatide. We also observed that the rate of change in BMD was greater at the distal 1/10 radius than at the 1/3 radius.ConclusionsConsidering these points, the effect of once-weekly teriparatide therapy can be observed at the radius. In clinics that do not have central DXA, but instead have radial DXA, these findings can help to evaluate the effect of once-weekly teriparatide treatment on osteoporosis.

show abstract

24-Month Open-Label Teriparatide Once-Weekly Efficacy Research Trial Examining Bone Mineral Density in Subjects with Primary Osteoporosis and High Fracture Risk

Cited by 17 publications

References 18 publications

Impact of patient background factors on the treatment efficacy of once-weekly teriparatide

Impact of patient background factors on the treatment efficacy of once-weekly teriparatide

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study

Utility of radius bone densitometry for the treatment of osteoporosis with once-weekly teriparatide therapy

Contact Info

Product

Resources

About