The effect of organic nitrates on osteoporosis

Completed

• Conditions: Osteoporosis; Musculoskeletal Diseases

• Registration Number: ISRCTN94484747
• Lead Sponsor: Women?s College Hospital (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

The pilot and main study have identical inclusion and exclusion criteria.

1. Women aged 50 and older
2. Lumbar spine BMD (L1 to L4) T score between 0 and -2.0
3. Greater than or equal to 3 years post-menopausal

Exclusion Criteria

1. Prior low trauma hip or vertebral fracture; these subjects have OP and require treatment
2. Total hip or femoral neck T score of less than -2.0; these subjects either have OP and require treatment, or are at increased risk of developing OP over the course of the main study
3. Bone disorders other than osteopenia (e.g. hyperparathyroidism or Paget?s disease); these subjects require treatment
4. Treatment within six months of study entry with androgen, calcitonin, oestrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/day for 12 months or greater, lithium or anticonvulsants. These agents can alter levels of bone turnover markers for up to six months.
5. Alendronate or risedronate use for at least four weeks, within the last three years. These agents may influence bone remodeling for up to three years.
6. Current treatment with nitrates
7. Systolic blood pressure of less than 100 mmHg or diastolic blood pressure greater than 110 mmHg at the baseline screening examination
8. Abnormal electrocardiogram (ECG) at the baseline screening examination
9. History of myocardial infarction, angina, valvular or congenital heart disease
10. Disabling conditions that may interfere with follow-up visits
11. Inability to give informed consent
12. Migraine headaches; nitrates can exacerbate migraines
13. Hypersensitivity to nitrates

Study & Design

• Study Type: Interventional
• Study Design: Not specified