Evidence map›Paper›PMID 35977548›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2022

Abaloparatide Increases Lumbar Spine and Hip BMD in Japanese Patients With Osteoporosis: The Phase 3 ACTIVE-J Study.

Toshio Matsumoto, Teruki Sone, Satoshi Soen, Sakae Tanaka, Akiko Yamashita, Tetsuo Inoue

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 7 pooled it
6.4field-weighted citation impact, top 2% 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

29 citing papers in PubMed, 7 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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  5. PTH1 receptor agonists for fracture risk: a systematic review and network meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
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  10. Modern pharmacological management of Osteoporosis: from monotherapy to sequential and combination approaches in postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
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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

6 authors at 5 institutions in 1 country.

Toshio MatsumotoFujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima 770-8503, Japan.ORCID 0000-0002-0618-0941
Teruki SoneDepartment of Nuclear Medicine, Kawasaki Medical School, Okayama 701-0952, Japan.
Satoshi SoenSoen Orthopaedics, Osteoporosis and Rheumatology Clinic, Hyogo 658-0072, Japan.
Sakae TanakaDepartment of Orthopedic Surgery, The University of Tokyo, Tokyo 113-0033, Japan.
Akiko YamashitaDivision of Pharmaceutical Development and Production, Teijin Pharma Limited, Tokyo 100-8585, Japan.
Tetsuo InoueAoyama General Hospital, Aichi 441-0195, Japan.
Aoyama Hospital Tokyo Women’s Medical University · JPKawasaki Medical School · JPTeijin (Japan) · JPTokushima University · JPUniversity of Tokyo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextAbaloparatide reduced fracture risk in postmenopausal women with osteoporosis in the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE). Its effect in Japanese patients remains unexamined.

objectiveThis work aimed to determine the efficacy and safety of abaloparatide in increasing bone mineral density (BMD) in Japanese patients with osteoporosis at high fracture risk.

methodsThis was a randomized, double-blind, placebo-controlled study conducted in Japan. Postmenopausal women and men with osteoporosis with high fracture risk were given daily subcutaneous 80 µg abaloparatide or placebo for 78 weeks (18 months). The primary end point was percentage change in lumbar spine (LS) BMD from baseline at the last visit. Secondary end points included time-course changes in LS, total hip (TH), and femoral neck (FN) BMDs and bone turnover markers, and cumulative number of fractures.

resultsAbaloparatide increased LS, TH, and FN BMDs (mean [95% CI]) by 12.5% (10.3%-14.8%; P < .001), 4.3% (3.3%-5.3%), and 4.3% (2.9%-5.6%), respectively, vs placebo. Serum procollagen type I N-terminal propeptide increased rapidly to ~ 140% above baseline at 6 weeks and gradually decreased but was approximately 25% higher than baseline at 78 weeks. Serum carboxy-terminal cross-linking telopeptide of type I collagen gradually increased to 50% above baseline at 24 weeks and decreased gradually to the placebo-group level from 60 weeks. Four vertebrae of 3 participants in the placebo group, but none in the abaloparatide group, developed new vertebral fractures. The safety profile was similar to that in the ACTIVE study.

conclusionIn Japanese patients with postmenopausal and male osteoporosis with high fracture risk, abaloparatide for 78 weeks robustly increased LS, TH, and FN BMDs, suggesting a similar efficacy in Japanese patients vs the ACTIVE study population.

Indexed as

Bone Density Conservation AgentsOsteoporosisOsteoporosis, PostmenopausalBone DensityCollagen Type IDouble-Blind MethodFemaleHumansJapanLumbar VertebraeMaleParathyroid Hormone-Related ProteinabaloparatideBone Density Conservation AgentsCollagen Type IParathyroid Hormone-Related Proteinabaloparatidebone formationbone mineral densityfracture riskvertebral fracture

Identifiers

PMID35977548
PMCPMC9516124
OpenAlexW4292340976

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.