The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Toronto
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

• Women aged 50 and older

• Lumbar spine BMD (L1 to L4) T score between 0 and -2.0

• At least 3 years postmenopausal

Exclusion Criteria:

• Prior low trauma hip or vertebral fracture

• Total hip or femoral neck T score of <-2.0

• Bone disorders other than osteopenia (e.g., hyperparathyroidism or Paget's disease)

• Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/d for 12 months or greater, lithium or anticonvulsants

• Alendronate or risedronate use for at least four weeks, within the last three years

• Current treatment with nitrates

• Systolic blood pressure of =<100 mm Hg or diastolic blood pressure >=100 mm Hg at the baseline screening examination

• Abnormal electrocardiogram (ECG) at the baseline screening examination

• history of myocardial infarction, angina, valvular or congenital heart disease

• Disabling conditions that may interfere with follow-up visits

• Inability to give informed consent

• Migraine headaches

• Hypersensitivity to nitrates