Status:
COMPLETED
The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE3
Brief 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 peo...
Detailed Description
This proposal consists of two studies. The objective of the first study is to determine which of isosorbide mononitrate (ISMO) at 20 mg/day or nitroglycerin ointment (NTG) at 15 mg/day results in fewe...
Eligibility Criteria
Inclusion
- Women aged 50 and older
- Lumbar spine BMD (L1 to L4) T score between 0 and -2.0
- At least 3 years postmenopausal
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT00252421
Start Date
October 1 2005
End Date
July 1 2010
Last Update
May 21 2014
Active Locations (1)
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1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2