Evidence map›Paper›PMID 31674641›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2020

Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT.

Sabashini K Ramchand, Natalie L David, Benjamin Z Leder, Joy N Tsai

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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02176382 (Denosumab and Teriparatide Study), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.9field-weighted citation impact, top 16% 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.

NCT02176382 phase4completednot on this map

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

TypeinterventionalSponsorMassachusetts General HospitalRan2014 to 2020Enrolled76ConditionsPostmenopausal OsteoporosisArmsdenosumab, teriparatide, Zoledronic acid
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
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

4 authors at 1 institution in 2 countries.

Sabashini K RamchandDepartment of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.
Natalie L DavidDepartment of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.
Benjamin Z LederDepartment of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.
Joy N TsaiDepartment of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.
Harvard University · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Novel combination therapies in the treatment of osteoporosisK24AR067847 · NIAMS · MASSACHUSETTS GENERAL HOSPITAL · PI LEDER, BENJAMIN Z · 2015 to 2019
$926k
Effect of Anabolic and Antiresorptive Therapy on Bone Quality in OsteoporosisK23AR068447 · NIAMS · MASSACHUSETTS GENERAL HOSPITAL · PI TSAI, JOY · 2015 to 2019
$818k
NCATS NIH HHS UL1 TR001102NIAMS NIH HHS K23 AR068447NIAMS NIH HHS K24 AR067847
6 · The paper itself

Abstract

contextIn the Denosumab and High-Dose Teriparatide Administration (DATA-HD) study, we reported that 15 months of combined high-dose (HD) teriparatide and denosumab increased mean areal bone mineral density (aBMD) at the hip and spine more than combined denosumab and standard-dose (SD) teriparatide.

objectiveIn the current analysis, we compare the individual rates of aBMD response between the treatment groups.

designSingle-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration). The proportion of participants in the SD and HD groups experiencing total hip, femoral neck, and lumbar spine aBMD gains of >3%, >6%, and >9% were compared.

participantsPostmenopausal women with osteoporosis completing all study visits (n = 60). MAIN OUTCOME MEASURE(S): aBMD (dual x-ray absorptiometry).

resultsAt the end of the 15-month treatment period, a higher proportion of women in the HD group had aBMD increases >3% (83% vs. 58%, P = .037) and >6% (45% vs. 19%, P = .034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P = .044). At the lumbar spine, >3% response rates were similar, whereas the >6% and >9% response rates were greater in the HD group (100% vs. 79%, P = .012 and 93% vs. 59%, P = .003, respectively).

conclusionCompared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD. These results suggest that this approach may provide unique benefits in the treatment of postmenopausal osteoporosis.

Indexed as

Absorptiometry, PhotonAgedBone DensityBone Density Conservation AgentsDenosumabDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFemur NeckHumansLumbar VertebraeMiddle AgedOsteoporosis, PostmenopausalTeriparatideTreatment OutcomeBone Density Conservation AgentsDenosumabTeriparatide

Identifiers

PMID31674641
PMCPMC7112977
OpenAlexW2985892442

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.