The Effects of Organic Nitrates on Osteoporosis: Part 2

NCT00252421 Phase 3 COMPLETED

Osteoporosis or "thinning of the bones" affects in 1 in 4 Canadian women and 1 in 8 Canadian men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the number of people afflicted with osteoporosis continues to rise. The most serious complication of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in long hospital stays, dependence on others, and premature death. While there are several medications that prevent osteoporosis they all have side effects. For example, postmenopausal women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and heart disease. In addition, drugs to prevent osteoporosis are expensive and not available worldwide. Therefore, it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis. The purpose of the research is to determine if nitrates, a group of drugs that are widely available, inexpensive, and commonly used to treat chest pain or angina, can prevent osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely available, inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified. This will improve the health of patients with osteoporosis worldwide.

Details

Lead sponsor	University of Toronto
Phase	Phase 3
Status	COMPLETED
Enrolment	243
Start date	2005-10
Completion	2010-07

Conditions

• Osteoporosis

Interventions

• Nitroglycerin ointment 15 mg/day daily for 24 month
• Placebo ointment daily for 24 month

Primary outcomes

• Pilot Study: Mean headache score associated with each of intermittent nitroglycerin ointment (NTG) and isosorbide mononitrate (ISMO) use — 6 months
• Main Study: Change from baseline in bone mineral density (BMD) at the lumbar spine over 24 months — 48 months

Countries

Canada