Evidence map›Paper›PMID 19549739›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2009

Transdermal nitroglycerin therapy may not prevent early postmenopausal bone loss.

Sunil J Wimalawansa, Julia P Grimes, Alan C Wilson, Donald R Hoover

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01387672 (Nitrates and Bone Turnover), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% 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.

NCT01387672 phase3completednot on this mapstarted 2011, after this paper: background citation

Nitrates and Bone Turnover (NABT): Trial to Select the Best Nitrate Preparation

TypeinterventionalSponsorUniversity of TorontoRan2011 to 2014Enrolled265ConditionsOsteoporosisArmsNitrates (NABT Main trial), Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. The effects of organic nitrates on osteoporosis: a systematic review.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
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Article
  9. Protein Kinase G2 Is Essential for Skeletal Homeostasis and Adaptation to Mechanical Loading in Male but Not Female Mice.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2023
    Article
  10. Article
  11. Nitric oxide and bone: The phoenix rises again.The Journal of clinical investigation · 2021
    Article
  12. Nitric oxide and cyclic GMP functions in bone.Nitric oxide : biology and chemistry · 2018
    Review
  13. Article
  14. Intermittent Nitrate Use and Risk of Hip Fracture.The American journal of medicine · 2017
    Article
  15. A Novel, Direct NO Donor Regulates Osteoblast and Osteoclast Functions and Increases Bone Mass in Ovariectomized Mice.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017
    Article
  16. Nitrate Medications, Fractures, and Change in Bone Mineral Density in Postmenopausal Women: Results from the Women's Health Initiative.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2016
    Observational
  17. Article
  18. Review
  19. Article
  20. 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 1 country.

Sunil J WimalawansaDivision of Endocrinology, Department of Medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903-0019, USA. wimalasu@umdnj.edu
Julia P Grimes
Alan C Wilson
Donald R Hoover
Rutgers, The State University of New Jersey · US

Funding

Prevention of Postmenopausal Bone Loss with Nitric OxideR01AR048679 · NIAMS · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI WIMALAWANSA, SUNIL J · 2001 to 2007
$3.0M
NIAMS NIH HHS R01 AR048679NIAMS NIH HHS R01-AR48679
6 · The paper itself

Abstract

contextOsteoporosis is common among postmenopausal women; animal studies and human pilot studies support the concept of nitric oxide (NO) donors reducing bone mineral density loss.

objectiveThe objective of the study was to evaluate whether NO donor, nitroglycerin, prevents postmenopausal bone loss.

designThis was a 3-yr randomized, double blinded, single-center, placebo-controlled clinical trial.

settingThe single-center study was conducted at the University of Medicine and Dentistry-Robert Wood Johnson Medical School (New Brunswick, NJ).

participantsParticipants included 186 postmenopausal women aged 40-65 yr, with lumbar bone mineral density (BMD) T-scores of 0 to -2.5.

interventionWomen, stratified by lumbar T-score (<-1.50 and >or=-1.50) and years since menopause (<or=5 and >5 yr), were randomized to receive nitroglycerin ointment (22.5 mg as Nitro-Bid) or placebo ointment received daily for 3 yr. Both groups took 630 mg daily calcium plus 400 IU vitamin D supplements. MEASUREMENTS: BMD was measured at 6 months and annually by dual-energy x-ray absorptiometry. Percent change in lumbar vertebrae BMD was the primary outcome. Hip BMD, total body bone mineral content, and height were secondary outcomes.

resultsAfter 36 months of therapy, changes of -2.1% in the active group (n = 88) and -2.5% in the placebo group (n = 82) in lumbar spine BMD were seen (P = 0.59; 95% confidence interval -1.001, 1.975). Secondary outcomes also did not differ by intervention arm. The active group reported more headaches compared with the placebo group (57 vs. 14%, P < 0.001). Other adverse and serious adverse events were not different.

conclusionsBMD changes did not substantially differ between postmenopausal women who received the dose of nitroglycerin tested, in comparison with a placebo. Once-daily dosing with 22.5 mg of transdermal-administered nitroglycerin was not effective (compliance adjusted dose was only approximately 16 mg/d); a sub-therapeutic dose.

Indexed as

Administration, CutaneousAdultAgedBone DensityDouble-Blind MethodFemaleHumansMiddle AgedNitric Oxide DonorsNitroglycerinOsteoporosis, PostmenopausalNitric Oxide DonorsNitroglycerin

Identifiers

PMID19549739
PMCPMC2741715
OpenAlexW2116677028

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.