The effects of organic nitrates on osteoporosis: a randomized controlled trial [ISRCTN94484747]
2006

Effects of Organic Nitrates on Osteoporosis

Sample size: 280 publication 10 minutes Evidence: moderate

Author Information

Author(s): Sophie A Jamal, Celeste J Hamilton, Dennis Black, Steven R Cummings

Primary Institution: University of Toronto and Division of Endocrinology and Metabolism, St. Michael's Hospital, Toronto, Canada

Hypothesis

Women will report fewer headaches when they are randomized to intermittent nitroglycerin ointment at 15 mg/day compared to intermittent oral isosorbide mononitrate at 20 mg/day, and after two years, women randomized to intermittent nitrates will have a greater percent increase in lumbar spine bone mineral density compared with women randomized to placebo.

Conclusion

The study found that transdermal nitroglycerin was associated with fewer headaches than oral isosorbide mononitrate and is currently recruiting patients for the main study.

Supporting Evidence

  • Transdermal nitroglycerin was associated with fewer headaches than oral isosorbide mononitrate.
  • Women taking nitrates intermittently had higher bone mass than those who took nitrates continuously.
  • Intermittent use of nitrates may improve bone mass while continuous use may lead to tachyphylaxis.

Takeaway

This study is trying to find out if a type of medicine called nitrates can help women with weak bones feel better and have fewer headaches.

Methodology

A multicentre randomized controlled trial with two studies: one to compare headache frequency between two nitrate treatments and another to assess the impact of intermittent nitrates on bone mineral density in postmenopausal women.

Potential Biases

Potential bias due to self-reported headache severity and participant drop-out rates.

Limitations

The study is limited to postmenopausal women and may not be generalizable to men or younger women.

Participant Demographics

Postmenopausal women aged 50 and older with lumbar spine BMD T scores between 0 and -2.0.

Statistical Information

P-Value

0.004

Confidence Interval

95% CI: 25.8 to 64.9

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-7-10

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