Dataset Information

Response to teriparatide in Chinese patients with established osteoporosis: osteocalcin and lumbar spine bone-mineral density changes from teriparatide Phase III study.

ABSTRACT: Teriparatide is the first anabolic agent for osteoporosis, and this analysis aimed to understand responses to teriparatide in Chinese patients with established osteoporosis in subgroups. In this Phase III study of teriparatide in China, 362 patients were randomized at a 2:1 ratio to receive subcutaneous teriparatide (20 ?g/day) or intranasal salmon calcitonin (200 IU/day) for 24 weeks. Teriparatide treatment produced a significantly greater increase in lumbar spine bone-mineral density (LS-BMD) in postmenopausal women than calcitonin at the 24-week end point. The relationship between osteocalcin (OCN) and LS-BMD was evaluated, and the greatest correlation was found between absolute OCN change at week 12 and percentage change in LS-BMD for patients in the teriparatide group (r=0.24, P<0.001). The correlation weakened at week 24 (r=0.16, P=0.02) and was negligibly negative for calcitonin-treated patients. Proportions of patients achieving >10 ?g/L absolute OCN change from baseline in the teriparatide- and calcitonin-treated groups were 81% and 6% at week 12, respectively (P<0.001). Proportions of patients with increased LS-BMD ?3% at week 24 from baseline were 71% and 35% in the teriparatide- and calcitonin-treated groups, respectively (P<0.001). Proportions of patients meeting both criteria were 63% for the teriparatide group and 1% for the calcitonin-treated group (P<0.001). Subgroup analysis suggested that significant increases in LS-BMD and OCN can be achieved in patients receiving teriparatide, regardless of baseline age, LS-BMD, and fracture times. The rate of treatment-emergent adverse events in each subgroup was similar to the overall analysis.

SUBMITTER: Lu C

PROVIDER: S-EPMC5644555 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Response to teriparatide in Chinese patients with established osteoporosis: osteocalcin and lumbar spine bone-mineral density changes from teriparatide Phase III study.

Lu Chunyan C Chen Yun Y Zhang Bin B Chen Yu Y Bai Fan F Chen Decai D

Clinical interventions in aging 20171012

Teriparatide is the first anabolic agent for osteoporosis, and this analysis aimed to understand responses to teriparatide in Chinese patients with established osteoporosis in subgroups. In this Phase III study of teriparatide in China, 362 patients were randomized at a 2:1 ratio to receive subcutaneous teriparatide (20 μg/day) or intranasal salmon calcitonin (200 IU/day) for 24 weeks. Teriparatide treatment produced a significantly greater increase in lumbar spine bone-mineral density (LS-BMD) ...[more]

PMID: 29066877

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Project description:Without antiresorptive therapy, postmenopausal women lose bone mass after teriparatide (TPTD) discontinuation; estrogen treatment prevents bone loss in this setting. It is not known whether premenopausal women with regular menses lose bone mass after teriparatide discontinuation.This study aimed to test the hypothesis that normally menstruating premenopausal women with idiopathic osteoporosis (IOP) will maintain teriparatide-associated bone mineral density (BMD) gains after medication cessation.Twenty-one premenopausal IOP women previously enrolled in an open-label pilot study of teriparatide (20 mcg for 18-24 mo), had substantial BMD increases at the lumbar spine (LS; 10.8 ± 8.3%), total hip (TH; 6.2 ± 5.6%), and femoral neck (7.6 ± 3.4%). For this study, BMD was remeasured 2.0 ± 0.6 years after teriparatide cessation.Fifteen women, who had gained 11.1 ± 7.2% at LS and 6.1 ± 6.5% at TH and were premenopausal at teriparatide completion, were followed without antiresorptive treatment.Two years after completing teriparatide, BMD declined by 4.8 ± 4.3% (P = .0007) at the LS. In contrast, BMD remained stable at the femoral neck (-1.5 ± 4.2%) and TH (-1.1 ± 3.7%). Those who sustained LS bone loss >3% (-7.3 ± 2.9%; n = 10), did not differ from those with stable LS BMD (0.1 ± 1.1%; n=5) with regard to baseline body mass index, BMD at any site, or duration of followup, but were significantly older at re-evaluation (46 ± 3 vs 38 ± 7; P = .046), had larger increases in LS BMD during teriparatide treatment and higher cancellous bone remodeling on transiliac biopsy at baseline and completion of teriparatide treatment. Serum bone turnover markers did not differ at baseline or teriparatide completion, but tended to be higher at the re-evaluation timepoint in those with post-teriparatide bone loss.These findings lead us to conclude that premenopausal women with IOP, particularly those over 40, may require antiresorptive treatment to prevent bone loss after teriparatide.

Project description:ObjectiveTeriparatide has been increasingly utilized in the management of osteoporosis. The efficacy of low and high dose teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain is unknown. We sought to determine the efficacy of teriparatide on these patient-important outcomes using a systematic review and meta-analysis.MethodsA systematic search of electronic databases (MEDLINE, EMBASE, CENTRAL, CINAHL) was performed to identify randomized controlled trials (RCTs) that evaluate teriparatide to any comparator for the treatment of osteoporosis in postmenopausal women. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria were used by two independent reviewers to assess the strength and quality of evidence.ResultsA total of 20 studies (n = 6024) were included in this review, with 2855 patients receiving teriparatide and 3169 patients receiving placebo or control treatment. A teriparatide dose of 20 μg/day increased lumbar spine bone mineral density (BMD) (standardized mean difference (SMD) 0.34 standard deviation (SD) units higher (95% CI 0.19-0.48 SDs higher) in comparison to placebo. Relative to anti-resorptive agents, 20 μg/day of teriparatide had a range from 0.14 SD units to 0.96 SD units higher (95% CI, 0.08 SDs lower to 0.36 SDs higher, CI, 0.33-1.59 SDs higher, respectively). 20 μg/day teriparatide had a significant effect on pain severity to placebo or control (SMD 0.80, 95% CI, 1.16-0.43 SDs lower) and also decreased the incidence of vertebral fractures compared to placebo (relative risk 0.31, 95% CI 0.21 to 0.46). Arthralgia and extremity pain incidence were also calculated; there were 15 and 8 fewer events per 1000 patients with the use of 20 μg/day of teriparatide compared to placebo or control, respectively.ConclusionHigh quality evidence supports the utilization of teriparatide 20 μg/day dose to significantly improve lumbar spine BMD and decrease incidence of vertebral fractures and pain severity relative to all comparators. 40 μg/day dose of teriparatide demonstrated significantly better results with prolonged treatment. This data is valuable for clinicians involved in the care of this growing demographic of patients. Further investigation on the safety and efficacy of teriparatide in higher doses for the long-term treatment of osteoporosis in postmenopausal women should be conducted through high-quality clinical trials.

Project description:BackgroundTo gain insight into how teriparatide affects various bone health parameters, we assessed the effects of teriparatide treatment with use of standard DXA (dual x-ray absorptiometry) technology and two newer technologies, high-resolution MRI (magnetic resonance imaging) and finite element analysis of quantitative CT (computed tomography) scans.MethodsIn this phase-4, open-label study, postmenopausal women with severe osteoporosis received 20 μg/day of teriparatide. Assessments included (1) changes in areal BMD (bone mineral density) (in g/cm2) at the radius, spine, and hip on DXA, (2) changes in volumetric BMD (in mg/cm3) at the spine and hip on quantitative CT scans, (3) changes in bone microarchitecture at the radius on high-resolution MRI, (4) estimated changes in spine and hip strength according to finite element analysis of quantitative CT scans, (5) changes in bone turnover markers in serum, and (6) safety.ResultsThirty-five subjects were enrolled; thirty completed eighteen months and twenty-five completed an optional six-month extension. No significant changes were observed for the primary outcome, high-resolution MRI at the distal aspect of the radius. At month eighteen, the least-squares mean percentage change from baseline in total volumetric BMD at the spine was 10.05% (95% confidence interval [CI], 6.83% to 13.26%; p < 0.001), and estimated spine strength increased 17.43% (95% CI, 12.09% to 22.76%; p < 0.001). Total volumetric BMD at the hip increased 2.22% (95% CI, 0.37% to 4.06%; p = 0.021), and estimated hip strength increased 2.54% (95% CI, 0.06% to 5.01%; p = 0.045). Areal BMD increased at the lumbar spine and femoral neck, was unchanged for the total hip and at the distalmost aspect of the radius, and decreased at a point one-third of the distance between the wrist and elbow. Bone turnover markers increased at months three, six, and twenty-four (all p < 0.05). No unexpected adverse events were observed.ConclusionsHigh-resolution MRI failed to identify changes in bone microarchitecture at the distal aspect of the radius, a non-weight-bearing site that may not be suitable for assessing effects of an osteoanabolic agent. Teriparatide increased areal BMD at the spine and femoral neck and volumetric BMD at the spine and hip. Estimated vertebral and femoral strength also increased. These findings and increases in bone turnover markers through month twenty-four are consistent with the known osteoanabolic effect of teriparatide.Level of evidenceTherapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

Response to teriparatide in Chinese patients with established osteoporosis: osteocalcin and lumbar spine bone-mineral density changes from teriparatide Phase III study.

Publications

Response to teriparatide in Chinese patients with established osteoporosis: osteocalcin and lumbar spine bone-mineral density changes from teriparatide Phase III study.

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