Evidence map›Paper›PMID 27895472›Full record

Observational studyClinical interventions in aging2016

Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study.

Atsushi Nishikawa, Fumito Yoshiki, Masanori Taketsuna, Kenta Kajimoto, Hiroyuki Enomoto

Abstract readObservational Study
PubMed Full text at PMC Publisher
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 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing 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

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

  1. Pooled it
  2. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Trial
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  10. Characteristics and treatment options of 272,152 geriatric patients with very high and high fracture risk.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Article
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  12. Observational
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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, Eli Lilly Japan K.K.
Fumito YoshikiMedicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Masanori TaketsunaMedicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Kenta KajimotoMedicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Hiroyuki EnomotoMedicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Teriparatide (recombinant 1-34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 μg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed.

Indexed as

AgedAged, 80 and overBone DensityBone Density Conservation AgentsFemaleHumansIncidenceJapanMiddle AgedOsteoporosisOsteoporotic FracturesPeptide FragmentsProcollagenProduct Surveillance, PostmarketingRenal Insufficiency, ChronicRiskBone Density Conservation AgentsPeptide FragmentsProcollagenprocollagen Type I N-terminal peptideTeriparatidebone mineral densitychronic kidney diseasefragility fractureparathyroid hormonesafetyteriparatide

Identifiers

PMID27895472
PMCPMC5117886

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Registered trials

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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.