Evidence map›Paper›PMID 24517156›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2014

Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial.

Benjamin Z Leder, Joy N Tsai, Alexander V Uihlein, Sherri-Ann M Burnett-Bowie, Yuli Zhu, Katelyn Foley, Hang Lee, Robert M Neer

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04467983 (Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone), which is not on this map. Cited by 134 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 14 pooled it
24.7field-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.

NCT04467983 phase4active not recruitingnot on this mapstarted 2021, after this paper: background citation

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

TypeinterventionalSponsorHospital for Special Surgery, New YorkRan2021 to 2026Enrolled70ConditionsOsteoporosis, PostmenopausalArmsDenosumab Injection, Abaloparatide
3 · Its place in the literature

Who cites it

134 citing papers in PubMed, 14 syntheses or guidelines pooled it, 271 citations in OpenAlex.

  1. Pooled it
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  7. 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
    Pooled it
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  10. 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
    Pooled it
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  13. 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
    Pooled it
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  15. 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
    Trial
  16. Impact of standard versus cyclic teriparatide and denosumab treatment on trabecular bone score: a post-hoc analysis of a randomized clinical trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Trial
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  20. The Effect of Zoledronic Acid on Bone Microarchitecture and Strength after Denosumab and Teriparatide Administration: DATA-HD Study Extension.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2023
    Trial

74 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Benjamin Z LederDepartment of Medicine, Endocrine Unit (B.Z.L., J.N.T., A.V.U., S.-A.M.B.-B., Y.Z., K.F., R.M.N.) and Biostatistics Center (H.L.), Massachusetts General Hospital, Boston, Massachusetts 02114.
Joy N Tsai
Alexander V Uihlein
Sherri-Ann M Burnett-Bowie
Yuli Zhu
Katelyn Foley
Hang Lee
Robert M Neer
Massachusetts 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
NCRR NIH HHS 1 ULI RR025758-04NCRR NIH HHS UL1 RR025758
6 · The paper itself

Abstract

contextCurrent osteoporosis medications increase bone mineral density (BMD) modestly and reduce, but do not eliminate, fracture risk. Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful. Conversely, 12 months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone.

objectiveThe purpose of this study was to determine whether 24 months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent.

designPreplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.

participantsParticipants were 94 postmenopausal women with osteoporosis. OUTCOME MEASURES: Lumbar spine, femoral neck, total hip, and distal radius BMD and serum markers of bone turnover were measured.

resultsAt 24 months, lumbar spine BMD increased more in the combination group (12.9 ± 5.0%) than in either the teriparatide (9.5 ± 5.9%, P = .01) or denosumab (8.3 ± 3.4%, P = .008) groups. Femoral neck BMD also increased more in the combination group (6.8 ± 3.6%) than in either the teriparatide (2.8 ± 3.9%, P = .003) or denosumab (4.1 ± 3.8%, P = .008) groups. Similarly, total hip BMD increased more in the combination group (6.3 ± 2.6%) than in the teriparatide (2.0 ± 3.0%) or denosumab (3.2 ± 2.5%) groups (P < .001 for both). Although spine and hip BMD continued to increase in the second year in all groups, these year 2 increases did not differ among groups. Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups, whereas osteocalcin decreased more in the denosumab group than in the combination group, a difference that persisted, but lessened, in the second year of therapy.

conclusionsTwo years of concomitant teriparatide and denosumab therapy increases BMD more than therapy with either medication alone and more than has been reported with any current therapy. The combination of these agents may prove to be an important treatment option in patients at high risk of fracture.

Indexed as

AgedAntibodies, Monoclonal, HumanizedBiomarkersBone DensityBone Density Conservation AgentsDenosumabDrug Therapy, CombinationFemaleHumansMiddle AgedOsteoporosis, PostmenopausalProcollagenTeriparatideTreatment OutcomeAntibodies, Monoclonal, HumanizedBiomarkersBone Density Conservation AgentsDenosumabProcollagenTeriparatide

Identifiers

PMID24517156
PMCPMC4010689
OpenAlexW2102177673

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.