Evidence map›Paper›PMID 21927922›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2012

Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women.

N Freemantle, S Satram-Hoang, E-T Tang, P Kaur, D Macarios, S Siddhanti, J Borenstein, D L Kendler, DAPS Investigators

4 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 129 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 15 pooled it
–field-weighted citation impact
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.

NCT00518531 phase3completednot on this map

A Multicenter, Randomized, Cross-Over, Open-label Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Alendronate in Postmenopausal Women With Low Bone Mineral Density

TypeinterventionalSponsorAmgenRan2007 to 2010Enrolled250ConditionsOsteoporosisArmsalendronate, denosumab
NCT03396315 phase2completednot on this mapstarted 2018, after this paper: background citation

Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis

TypeinterventionalSponsorColumbia UniversityRan2018 to 2023Enrolled24ConditionsIOP, OsteoporosisArmsAlendronate, Zoledronic Acid
NCT04338529 completednot on this mapstarted 2020, after this paper: background citation

Alendronate in an Weekly Effervescent Tablet Formulation for Preservation of Bone Mass After Denosumab Discontinuation in Postmenopausal Women with Low Bone Mass. an Observational Study (Binosto After Denosumab - the BAD Study)

TypeobservationalSponsor251 Hellenic Air Force & VA General HospitalRan2020 to 2024Enrolled92ConditionsPostmenopausal OsteoporosisArmsBinosto 70Mg Effervescent Tablet
NCT04403698 phase2completednot on this mapstarted 2019, after this paper: background citation

The Use of Buffered Soluble Alendronate 70 mg (Steovess/Binosto) After Denosumab Discontinuation to Prevent Increase in Bone Turnover

TypeinterventionalSponsorUniversity Hospital, GhentRan2019 to 2022Enrolled30ConditionsErosive OsteoarthritisArmsAlendronate Effervescent Oral Tablet
3 · Its place in the literature

Who cites it

129 citing papers in PubMed, 15 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Denosumab vs. bisphosphonates in primary osteoporosis: a meta-analysis of comparative safety in 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 · 2024
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Osteoporosis Management in the Era of COVID-19.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2020
    Guideline
  9. Pooled it
  10. Pooled it
  11. 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
  12. Pooled it
  13. Persistence with denosumab and persistence with oral bisphosphonates for the treatment of postmenopausal osteoporosis: a retrospective, observational study, and a 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 · 2015
    Pooled it
  14. Interventions to improve osteoporosis medication adherence and persistence: a systematic review and literature appraisal by the ISPOR Medication Adherence & Persistence Special Interest Group.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2013
    Pooled it
  15. Treatment failure in osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2012
    Guideline
  16. Trial
  17. Trial
  18. Perioperative teriparatide for preventing proximal junctional kyphosis and failure in patients with osteoporosis after adult thoracolumbar spinal deformity surgery: a prospective randomized controlled 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
  19. Trial
  20. Trial

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

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

9 authors.

N FreemantleUniversity of Birmingham, Birmingham, UK. nicholas.freemantle@ucl.ac.uk
S Satram-Hoang
E-T Tang
P Kaur
D Macarios
S Siddhanti
J Borenstein
D L Kendler
DAPS Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledThe final analysis of this 2-year, randomized, crossover study showed that postmenopausal women with osteoporosis were more adherent, compliant, and persistent with subcutaneous denosumab injections every 6 months than with once-weekly alendronate tablets. After receiving both treatments, women reported greater satisfaction with injectable denosumab and preferred it over oral alendronate.

introductionOsteoporosis patients who are non-compliant or non-persistent with therapy may have suboptimal clinical outcomes. This 2-year, randomized, open-label, crossover study compared treatment adherence between subcutaneous denosumab, 60 mg every 6 months, and oral alendronate, 70 mg once weekly.

methodsPostmenopausal women at 25 centers in the USA and Canada with bone mineral density T-scores -4.0 to -2.0 and no prior bisphosphonate use received alendronate then denosumab, or denosumab then alendronate, over successive 12-month periods. Adherence required both compliance (denosumab injections 6 months apart or ≥ 80% of alendronate tablets) and persistence (both denosumab injections or ≥ 2 alendronate doses in the last month and completion of the treatment period).

resultsOf the 250 women enrolled (124 alendronate, 126 denosumab), 221 entered the second year (106 denosumab, 115 alendronate). Denosumab was associated with less non-adherence than alendronate (first year, 11.9% vs 23.4%; second year, 7.5% vs 36.5%). Risk ratios for non-adherence, non-compliance, and non-persistence favored denosumab in both years (p < 0.05). Of 198 subjects expressing treatment preference, 183 (92.4%) preferred the injections over the oral therapy. BMD improved further when subjects received denosumab after alendronate and remained stable when they received alendronate after denosumab.

conclusionBased on the final results of this crossover study after women had received each treatment for up to 1 year, postmenopausal women with osteoporosis were more adherent, compliant, and persistent with subcutaneous denosumab injections every 6 months than with once-weekly alendronate tablets and reported increased treatment preference and satisfaction with injectable denosumab over oral alendronate.

Indexed as

Patient PreferenceAdministration, OralAgedAlendronateAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBone DensityBone Density Conservation AgentsCross-Over StudiesDenosumabDrug Administration ScheduleFemaleHumansInjections, SubcutaneousMedication AdherenceMiddle AgedAlendronateAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBone Density Conservation AgentsDenosumabRANK Ligand

Identifiers

PMID21927922
PMCPMC3249211

What OpenQuestion holds

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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.