Evidence map›Paper›PMID 30536713›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2019

Comparison of BMD Changes and Bone Formation Marker Levels 3 Years After Bisphosphonate Discontinuation: FLEX and HORIZON-PFT Extension I Trials.

Tiffany Y Kim, Douglas C Bauer, Brian L McNabb, Anne L Schafer, Felicia Cosman, Dennis M Black, Richard Eastell

Abstract readClinical Trial, Phase IComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Guideline
  3. One versus 2 years of alendronate following denosumab: the CARD extension.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
    Trial
  4. Prolonged bone health benefits for breast cancer patients following adjuvant bisphosphonate therapy: the BoHFAB study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2024
    Trial
  5. Early changes in bone turnover and bone mineral density after discontinuation of long-term oral bisphosphonates: a post hoc analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Trial
  6. Article
  7. Review
  8. Article
  9. Article
  10. Bisphosphonate drug holidays in osteoporosis according to fracture risk profile.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Observational
  11. Article
  12. Review
  13. Article
  14. Review
  15. Romosozumab and antiresorptive treatment: the importance of treatment sequence.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    Article
  16. Review
  17. Evaluation and management of atypical femoral fractures: an update of current knowledge.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2021
    Review
  18. Osteoprotective Roles of Green Tea Catechins.Antioxidants (Basel, Switzerland) · 2020
    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

7 authors.

Tiffany Y KimDepartment of Medicine, University of California, San Francisco, CA, USA.
Douglas C BauerDepartment of Medicine, University of California, San Francisco, CA, USA.
Brian L McNabbDepartment of Medicine, University of California, San Francisco, CA, USA.
Anne L SchaferDepartment of Medicine, University of California, San Francisco, CA, USA.
Felicia CosmanDepartment of Clinical Medicine, Columbia University, New York, NY, USA.
Dennis M BlackDepartment of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.
Richard EastellDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, UK.

Funding

DIABETES, ENDOCRINOLOGY &METABOLISM TRAINING PROGRAMT32DK007418 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI EDWARD C HSIAO · 1986 to 2026
$14.3M
Skeletal Biology and Biomechanics (SBB) CoreP30AR075055 · NIAMS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI EDWARD C HSIAO · 2019 to 2026
$7.1M
Medical Research Council MR/K006312/1Medical Research Council MR/P020941/1NIAMS NIH HHS P30 AR075055NIDDK NIH HHS T32 DK007418
6 · The paper itself

Abstract

An ASBMR Task Force recommends a drug holiday for certain women treated for ≥5 years with oral alendronate or ≥3 years with intravenous zoledronic acid, with reassessment 2 to 3 years later. It is not known whether changes in bone mineral density (BMD) or bone turnover markers differ after oral or intravenous therapy. Our goal was to compare changes in BMD and procollagen type I N propeptide (PINP) after oral or intravenous bisphosphonate use. In the Fracture Intervention Trial Long-term Extension (FLEX), women who received a mean 5 years of alendronate were randomized to placebo or continued treatment. In the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial Extension I (HORIZON-PFT E1), women who received 3 years of zoledronic acid were randomized to placebo or continued treatment. We examined the proportion of participants with BMD loss or PINP gain ≥ least significant change (LSC) and those whose values exceeded a threshold (T-score ≤-2.5 or PINP ≥36.0 ng/mL, a premenopausal median value). After 3 years of placebo, the FLEX group had greater mean total hip BMD decreases (-2.3% versus -1.2% in the HORIZON-PFT E1 group, p < 0.01) and greater rises in PINP (+11.6 ng/mL versus +6.7 ng/mL, p < 0.01). There was a greater proportion of individuals in FLEX with total hip BMD loss and PINP increases that exceeded LSC, and PINP values ≥36.0 ng/mL. In contrast, there were small changes in the proportion of women with femoral neck T-scores ≤-2.5 in both groups. In conclusion, 3 years after bisphosphonate discontinuation, a considerable proportion of former alendronate and zoledronic acid users had meaningful declines in total hip BMD and elevations in PINP. Despite a longer treatment course, alendronate may have a more rapid offset of drug effect than zoledronic acid. © 2018 American Society for Bone and Mineral Research.

Indexed as

AgedAged, 80 and overAlendronateBiomarkersBone DensityFemaleFemur NeckHumansOsteogenesisZoledronic AcidAlendronateBiomarkersZoledronic AcidANTIRESORPTIVESBIOCHEMICAL MARKERS OF BONE TURNOVERDXAOSTEOPOROSIS

Identifiers

PMID30536713
PMCPMC10463267

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.