Evidence map›Paper›PMID 37505256›Full record

Trial reportJournal of bone and mineral metabolism2023

Abaloparatide dose-dependently increases bone mineral density in postmenopausal women with osteoporosis: a phase 2 study.

Toshio Matsumoto, Teruki Sone, Akiko Yamashita, Tetsuo Inoue

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
2.4field-weighted citation impact, top 11% 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

0 citing papers in PubMed, 10 citations in OpenAlex.

No citing paper in PubMed yet.

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

4 authors at 4 institutions in 1 country.

Toshio MatsumotoFujii Memorial Institute of Medical Sciences, Tokushima University, 3-18-15 Kuramoto-cho, Tokushima-shi, Tokushima, 770-8503, Japan. toshio.matsumoto@tokushima-u.ac.jp.ORCID http://orcid.org/0000-0002-0618-0941
Teruki SoneDepartment of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.
Akiko YamashitaDivision of Pharmaceutical Development and Production, Teijin Pharma Limited, Tokyo, Japan.
Tetsuo InoueAoyama General Hospital, Aichi, Japan.
Aoyama Hospital Tokyo Women’s Medical University · JPKawasaki Medical School · JPTeijin (Japan) · JPTokushima University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to determine the efficacy of abaloparatide in increasing bone mineral density (BMD) and its safety in postmenopausal Japanese women with osteoporosis. MATERIALS AND

methodsRandomized, double-blind, placebo-controlled, dose-finding study of abaloparatide in postmenopausal Japanese women at high fracture risk. The primary endpoint was the change in lumbar spine (LS) BMD from baseline at the last visit after daily subcutaneous injections of placebo or 40 or 80 µg abaloparatide. Other endpoints included time-course changes in LS BMD at 12, 24, and 48 weeks, in total hip (TH) and femoral neck (FN) BMDs, and in bone turnover markers.

resultsIncreases in LS BMD with 40 and 80 µg abaloparatide were significantly higher than that with placebo (6.6% and 11.5%, respectively), with significant between-group differences for the abaloparatide groups (4.9%). TH BMD increased by 0.4%, 1.6%, and 2.9% and FN BMD increased by 0.6%, 1.5%, and 2.4% in the placebo and 40 and 80 µg abaloparatide groups, respectively. Serum PINP rapidly increased by 67.3% and 140.7% and serum CTX slowly increased by 16.4% and 34.5% in the 40 and 80 µg abaloparatide groups, respectively. Although more adverse events were observed in the abaloparatide groups, they were mild to moderate and not dose dependent.

conclusionIn postmenopausal Japanese women with osteoporosis at high fracture risk, abaloparatide for 48 weeks dose-dependently increased LS, TH, and FN BMDs, supporting further investigation with 80 μg abaloparatide for the treatment of osteoporosis in this population. TRIAL REGISTRATION NUMBER: JapicCTI-132381.

Indexed as

Bone Density Conservation AgentsOsteoporosisOsteoporosis, PostmenopausalBone DensityDouble-Blind MethodFemaleHumansLumbar VertebraeParathyroid Hormone-Related ProteinPostmenopauseabaloparatideBone Density Conservation AgentsParathyroid Hormone-Related ProteinAbaloparatideAnabolic agentBone formationBone turnover markerPTHrP

Identifiers

PMID37505256
OpenAlexW4385330579

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.