Evidence map›Paper›PMID 32671481›Full record

Trial reportJournal of bone and mineral metabolism2020

Efficacy of denosumab co-administered with vitamin D and Ca by baseline vitamin D status.

Toshitsugu Sugimoto, Toshio Matsumoto, Takayuki Hosoi, Masataka Shiraki, Makiko Kobayashi, Naoki Okubo, Hideo Takami, Toshitaka Nakamura

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of bone and mineral metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Comparison of radiological and functional outcomes of conservative treatment with teriparatide and denosumab in thoracolumbar osteoporotic vertebral fracture.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
    Article
  4. Review
  5. Article
  6. 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

8 authors at 4 institutions in 1 country.

Toshitsugu SugimotoEikokai Ono Hospital, Tenjincho 973, Ono City, Hyogo, 675-1316, Japan. sugimoto@med.shimane-u.ac.jp.
Toshio MatsumotoFujii Memorial Institute of Medical Sciences, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.
Takayuki HosoiKenkoin Clinic, Tokyo, Japan.
Masataka ShirakiResearch Institute and Practice for Involutional Diseases, Nagano, Japan.
Makiko KobayashiMedical Science Department, Medical Affairs Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.
Naoki OkuboBiostatistics & Data Management Department, R&D Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.
Hideo TakamiDevelopment Function, R&D Division, Daiichi Sankyo Co. Ltd, Tokyo, Japan.
Toshitaka NakamuraTouto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.
Daiichi-Sankyo (Japan) · JPOno Pharmaceutical (Japan) · JPTokushima University · JPTokyo Teishin Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn anti-osteoporosis drug trials, vitamin D and calcium (Ca) are common supplements; however, the optimal dose of each is unclear. Using data from the randomized, double-blind, placebo-controlled DIRECT trial, we assessed whether baseline serum 25-hydroxy vitamin D (25[OH]D) level influences the efficacy of denosumab co-administered with vitamin D and Ca. MATERIALS AND

methodsIn this prespecified sub-analysis, subjects with primary osteoporosis who received denosumab or placebo, plus vitamin D (≥ 400 IU/day) and Ca (≥ 600 mg/day), were classified as 25(OH)D deficient (< 20 ng/mL), insufficient (≥ 20 to < 30 ng/mL), and sufficient (≥ 30 ng/mL). Study endpoints included absolute serum 25(OH)D level at baseline, 12 months, and 24 months; change in serum 25(OH)D and bone mineral density (BMD) status from baseline; and incidence of new vertebral fractures at 24 months.

resultsIn 475 denosumab-treated and 481 placebo-treated subjects, proportions with deficient/insufficient/sufficient 25(OH)D at baseline were 53.1%/37.1%/9.9% and 50.9%/42.0%/7.1%, respectively. Supplementation significantly increased mean serum 25(OH)D levels; at 24 months, mean levels were > 30 ng/mL (sufficient) in both treatment groups. Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups. At month 24, denosumab-treated subjects with deficient/insufficient baseline 25(OH)D had a significantly lower risk of new vertebral fracture vs. placebo-treated subjects.

conclusionAmong DIRECT trial subjects supplemented with ≥ 400 IU/day of vitamin D and ≥ 600 mg/day of Ca, baseline 25(OH)D sufficiency may not influence the efficacy of denosumab in increasing BMD or preventing vertebral fractures.

Indexed as

AgedBone DensityBone Density Conservation AgentsCalciumDenosumabDouble-Blind MethodFemaleHumansMaleSpinal FracturesTreatment OutcomeVitamin D25-hydroxyvitamin DBone Density Conservation AgentsCalciumDenosumabVitamin DBone mineral densityDeficiencyDenosumabFractureVitamin D insufficiency

Identifiers

PMID32671481
OpenAlexW3043647235

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.