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Submitted by rapper210 on December 26, 2006
Category: English
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The Effects of Organic Nitrates on Osteoporosis: A Randomized Controlled Trial [ISRCTN94484747]
Sophie A Jamal1, Celeste J Hamilton1, Dennis Black2 & Steven R Cummings3
1Department of Medicine, University of Toronto and Division of Endocrinology and Metabolism, St. Michael's Hospital, Toronto, Canada
2Department of Epidemiology and Biostatistics, University of California, San Francisco, USA
3California Pacific Medical Center Research Institute, San Francisco, USA
Published 9 26 April 2006
Trials 2006, 7:10 doi:10.1186/1745-6215-7-10
Abstract & Article
Background
Osteoporotic fractures are common and are associated with increased morbidity, mortality and health care costs. The most effective way to moderate increases in health care costs and the sickness and premature death associated with osteoporotic fractures, is to prevent osteoporosis. Several lines of evidence suggest that nitrates, drugs typically prescribed for the treatment of angina, may be effective in preventing postmenopausal osteoporosis.
Methods
We have designed a multicentre randomized controlled trial to determine the effects of nitrates on bone. The trial consists of two studies. The objective of the first study is to determine whether isosorbide mononitrate at 20 mg/day or nitroglycerin ointment at 15 mg/day leads to fewer headaches. The nitrate that is best tolerated will be used in a second study with one main objective: To determine if postmenopausal women with a T-score at the lumbar spine (L1 to L4) between 0 and -2.0 randomized to two years of treatment with intermittent nitrates have a greater increase in spine bone mineral density as compared to women randomized to placebo.
We hypothesize that: 1. Women will report fewer headaches when they are randomized to intermittent nitroglycerin ointment at 15 mg/day compared to intermittent oral isosorbide mononitrate at...
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