Evidence map›Paper›PMID 36862212›Full record

Observational studyJournal of bone and mineral metabolism2023

Safety and effectiveness of once-yearly zoledronic acid in Japanese osteoporosis patients: three-year post-marketing surveillance.

Junichi Takada, Shizu Sato, Kouichi Arai, Yoriko Kito, Yuko Oshita, Kazuko Saito

Open access · bronzeAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of bone and mineral metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 24% of its field
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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
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

6 authors at 2 institutions in 1 country.

Junichi TakadaOsteoporosis Center, Sapporo Kotoni Orthopaedics, 1-30 Kotoni 4-4, Nishi-Ku, Sapporo, Hokkaido, 063-0814, Japan.
Shizu SatoMedical Affairs Department, Asahi Kasei Pharma Corporation, 1-1-2, Yurakucho, Chiyoda-Ku, Tokyo, 100-0006, Japan.
Kouichi AraiMedical Affairs Department, Asahi Kasei Pharma Corporation, 1-1-2, Yurakucho, Chiyoda-Ku, Tokyo, 100-0006, Japan.
Yoriko KitoPharmacovigilance Department, Asahi Kasei Pharma Corporation, 1-1-2, Yurakucho, Chiyoda-Ku, Tokyo, 100-0006, Japan.
Yuko OshitaPharmacovigilance Department, Asahi Kasei Pharma Corporation, 1-1-2, Yurakucho, Chiyoda-Ku, Tokyo, 100-0006, Japan.
Kazuko SaitoPharmacovigilance Department, Asahi Kasei Pharma Corporation, 1-1-2, Yurakucho, Chiyoda-Ku, Tokyo, 100-0006, Japan. saito.kcj@om.asahi-kasei.co.jp.ORCID http://orcid.org/0000-0003-3319-7180
Asahi Kasei (Japan) · JPSapporo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionZoledronic acid (5 mg; ZOL), a once-yearly bisphosphonate, reduces osteoporotic fractures and increases bone mineral density (BMD). This 3-year post-marketing surveillance examined its real-world safety and effectiveness. MATERIALS AND

methodsThis prospective, observational study included patients who started ZOL for osteoporosis. Data were assessed at baseline, 12, 24, and 36 months for safety and effectiveness. Treatment persistence, potentially related factors, and persistence before and after the COVID-19 pandemic started were also investigated.

resultsThe safety analysis and effectiveness analysis sets included 1406 and 1387 patients, respectively, with mean age of 76.5 years. Adverse reactions (ARs) occurred in 19.35% of patients, with an acute-phase reaction in 10.31, 1.01, and 0.55% after the first, second, and third ZOL infusions. Renal function-related ARs, hypocalcaemia, jaw osteonecrosis, and atypical femoral fracture occurred in 1.71, 0.43, 0.43, and 0.07% of patients, respectively. Three-year cumulative fracture incidences were 4.44% for vertebral, 5.64% for non-vertebral, and 9.56% for clinical fractures. BMD increased by 6.79, 3.14, and 1.78% at the lumbar spine, femoral neck, and total hip, respectively, after 3-year treatment. Bone turnover markers remained within reference ranges. Treatment persistence was 70.34% over 2 years and 51.71% over 3 years. Male, age ≥ 75 years, no previous medicines for osteoporosis, no concomitant medicines for osteoporosis, and inpatient at the first infusion were related to discontinuation. There was no significant difference in the persistence rate between before and after the COVID-19 pandemic (74.7% vs. 69.9%; p = 0.141).

conclusionThis 3-year post-marketing surveillance confirmed the real-world safety and effectiveness of ZOL.

Indexed as

Bone Density Conservation AgentsOsteoporosisProduct Surveillance, PostmarketingAgedBone DensityCOVID-19DiphosphonatesEast Asian PeopleHumansImidazolesMalePandemicsProspective StudiesZoledronic AcidBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic AcidEffectivenessOsteoporosisPost-marketing surveillanceSafetyZoledronic acid

Identifiers

PMID36862212
PMCPMC9978276
OpenAlexW4322758478

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.