Evidence map›Paper›PMID 27462147›Full record

Observational studyClinical interventions in aging2016

Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report.

Atsushi Nishikawa, Takehiro Ishida, Masanori Taketsuna, Fumito Yoshiki, Hiroyuki Enomoto

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Clinical interventions in aging, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Osteoporosis in Patients with Chronic Kidney Diseases: A Systemic Review.International journal of molecular sciences · 2020
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Atsushi NishikawaGlobal Patient Safety Japan, Quality and Patient Safety.
Takehiro IshidaClinical Development Operations and Innovations, Medicine Development Unit Japan.
Masanori TaketsunaAsia Pacific Statistical Sciences, Medicine Development Unit Japan.
Fumito YoshikiMedical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Hiroyuki EnomotoMedical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations.

Indexed as

AdultAgedAged, 80 and overBone Density Conservation AgentsFemaleFractures, BoneHumansJapanMaleMiddle AgedOsteoporosisProduct Surveillance, PostmarketingProspective StudiesRisk FactorsTeriparatideBone Density Conservation AgentsTeriparatidebone biomarkersbone mineral densityparathyroid hormonequality of lifesafety

Identifiers

PMID27462147
PMCPMC4939987

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.