Evidence map›Paper›PMID 23099796›Full record

Trial reportEndocrine2013

Combination therapy with risedronate and teriparatide in male osteoporosis.

Marcella D Walker, Natalie E Cusano, James Sliney, Megan Romano, Chiyuan Zhang, Donald J McMahon, John P Bilezikian

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Endocrine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01611571 (Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis), which is not on this map. Cited by 47 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 14 pooled it
3.2field-weighted citation impact, top 7% 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.

NCT01611571 phase3completednot on this map

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis

TypeinterventionalSponsorColumbia UniversityRan2003 to 2011Enrolled31ConditionsOsteoporosisArmsRisedronate, Teriparatide, Placebo Teriparatide, placebo Risedronate
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 14 syntheses or guidelines pooled it, 76 citations in OpenAlex.

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  12. Combination therapy with parathyroid hormone analogs and antiresorptive agents for osteoporosis: a systematic review and meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

Marcella D WalkerMetabolic Bone Diseases Unit, Division of Endocrinology, Department of Medicine, College of Physicians and Surgeons, Columbia University, 630 West 168th Street, PH 8W-864, New York, NY 10032, USA. mad2037@columbia.edu
Natalie E Cusano
James Sliney
Megan Romano
Chiyuan Zhang
Donald J McMahon
John P Bilezikian
Columbia University · USColumbia College · CARoyal College of Physicians · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Most studies of combination therapy with teriparatide and a bisphosphonate have not shown greater efficacy over monotherapy. The bisphosphonate risedronate, has not been studied in this context. The purpose of this proof-of-concept study was to assess whether combination risedronate and teriparatide increases bone mineral density (BMD) more than monotherapy with either drug alone. This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD. The primary endpoint was percentage change in lumbar spine (LS) BMD at 18 months. Secondary outcomes included changes in bone markers and BMD at other sites and interim time-points. All therapies increased LS BMD as compared with baseline (p < 0.05), but there were no between-group differences at 18 months. Total hip (TH) BMD increased to a greater extent in the combination group (mean ± SEM, 3.86 ± 1.1 %) versus teriparatide (0.29 ± 0.95 %) or risedronate (0.82 ± 0.95 %; p < 0.05 for both). Femoral neck (FN) BMD also increased more in the combination group (8.45 ± 1.8 %) versus risedronate (0.50 ± 1.7 %; p = 0.002), but was not different from teriparatide alone. In the combination group, P1NP and CTX increased rapidly, mirroring the teriparatide-alone arm. There were no between-group differences in adverse events. Combination teriparatide and risedronate increased BMD at the LS, TH as well as the FN and provided greater BMD increases at the TH than monotherapy. The results suggest combination risedronate and teriparatide therapy holds promise as a treatment for osteoporosis.

Indexed as

AdultAgedAged, 80 and overBone DensityBone Density Conservation AgentsDouble-Blind MethodDrug Therapy, CombinationEtidronic AcidFemur NeckHumansInjections, SubcutaneousLumbar VertebraeMaleMiddle AgedOsteoporosisPlacebosBone Density Conservation AgentsEtidronic AcidPlacebosRisedronic AcidTeriparatide

Identifiers

PMID23099796
OpenAlexW2080881316

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.