Evidence map›Paper›PMID 23683600›Full record

Trial reportLancet (London, England)2013

Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial.

Joy N Tsai, Alexander V Uihlein, Hang Lee, Ruchit Kumbhani, Erica Siwila-Sackman, Elizabeth A McKay, Sherri-Ann M Burnett-Bowie, Robert M Neer, Benjamin Z Leder

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00926380 (The Denosumab And Teriparatide Administration Study), which is not on this map. Cited by 201 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
201citing papers in PubMed, 17 pooled it
41.8field-weighted citation impact, top 1% 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.

NCT00926380 phase2completednot on this map

The Denosumab And Teriparatide Administration Study (DATA)

TypeinterventionalSponsorMassachusetts General HospitalRan2009 to 2016Enrolled94ConditionsOsteoporosisArmsdenosumab, teriparatide
3 · Its place in the literature

Who cites it

201 citing papers in PubMed, 17 syntheses or guidelines pooled it, 479 citations in OpenAlex.

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  10. Denosumab is not associated with risk of malignancy: 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 · 2021
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  13. 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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  16. Denosumab compared to other treatments to prevent or treat osteoporosis in individuals at risk of fracture: a systematic review and 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 · 2016
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  18. Comparative bone histomorphometry effects of combined denosumab and teriparatide vs monotherapy in postmenopausal women with osteoporosis: a randomized controlled trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026
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141 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Joy N TsaiDepartment of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA.
Alexander V Uihlein
Hang Lee
Ruchit Kumbhani
Erica Siwila-Sackman
Elizabeth A McKay
Sherri-Ann M Burnett-Bowie
Robert M Neer
Benjamin Z Leder
Harvard University · USMassachusetts General Hospital · US

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
TRAINING PROGRAM IN ENDOCRINOLOGY AND DIABETEST32DK007028 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Karen K Miller · 1986 to 2026
$18.5M
NCRR NIH HHS UL1 RR025758NIDDK NIH HHS T32 DK007028
6 · The paper itself

Abstract

backgroundOsteoporosis medications increase bone-mineral density (BMD) and lower but do not eliminate fracture risk. The combining of anabolic agents with bisphosphonates has not improved efficacy. We compared combined teriparatide and denosumab with both agents alone.

methodsFrom September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial. Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both. BMD was measured at 0, 3, 6, and 12 months. Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00926380.

findings94 (94%) of 100 eligible women completed at least one study visit after baseline. At 12 months, posterior-anterior lumbar spine BMD increased more in the combination group (9·1%, [SD 3·9]) than in the teriparatide (6·2% [4·6], p=0·0139) or denosumab (5·5% [3·3], p=0·0005) groups. Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0·0001; denosumab 2·5% [2·6], p=0·0011).

interpretationCombined teriparatide and denosumab increased BMD more than either agent alone and more than has been reported with approved therapies. Combination treatment might, therefore, be useful to treat patients at high risk of fracture.

fundingAmgen, Eli Lilly, National Center for Research Resources.

Indexed as

AgedAntibodies, Monoclonal, HumanizedArea Under CurveBiomarkersBone DensityBone Density Conservation AgentsCombined Modality TherapyDenosumabDrug CombinationsFemaleHumansMiddle AgedOsteoporosis, PostmenopausalTeriparatideTreatment OutcomeAntibodies, Monoclonal, HumanizedBiomarkersBone Density Conservation AgentsDenosumabDrug CombinationsTeriparatide

Identifiers

PMID23683600
PMCPMC4083737
OpenAlexW1989880575

What OpenQuestion holds

Textmetadata
LicenceTDM
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.