itrates and Bone Turnover: Trial to select the best nitrate preparatio

Phase 3

Completed

• Conditions: Osteoporosis; Musculoskeletal Diseases

• Registration Number: ISRCTN08860742
• Lead Sponsor: Women's College Research Institute (Canada)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24010992

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-27
• Study Completion: 2013-12-31
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

Current inclusion criteria as of 10/01/2013:
1. Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
2. Women without a uterus will be eligible after age 55
3. Women previously treated with alendronate but stopped within 2 years of study commencement; or previously treated with risedronate but stopped within 1 year of study commencement; or previously treated with zoledronate (NABT-B only)

Previous inclusion criteria until 10/01/2013:
1. Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
2. Women without a uterus will be eligible after age 55

Exclusion Criteria

Current exclusion criteria as of 10/01/2013:
1. Previous fracture of the hip, wrist, spine or ankle
2. Diagnosis of Osteoporosis (NABT main study only)
3. History of bone disorders such as hyperparathyroidism or Paget?s disease
4. Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater)
5. Treatment with any antiresorptive agent, including alendronate, risedronate, use for at least four weeks, within the last three years and any previous treatment with intravenous zoledronate (NABT only)
6. Treatment with etidronate or denosumab use for at least four weeks, within the last three years and any previous treatment with parathyroid hormone
7. Current treatment with nitrates
8. Any history of migraine headaches (nitrates can exacerbate migraines)
9. History of angina or cardiovascular disease
10. Inability to give informed consent
11. Hypersensitivity to nitroglycerin
12. Allergies to the adhesive used in nitroglycerin patches
13. Acute circulatory failure associated with marked hypotension (shock and states of collapse)
14. Postural hypotension
15. Increased intracranial pressure
16. Increased intraocular pressure
17. Severe anemia.

Previous exclusion criteria until 10/01/2013:
1. Previous fracture of the hip, wrist, spine or ankle, or those who report a diagnosis of osteoporosis, (?osteopenia? will not be excluded)
2. History of bone disorders such as hyperparathyroidism or Paget?s disease
3. Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater)
4. Treatment with an antiresorptive agent, including alendronate, risedronate, etidronate or denosumab use for at least four weeks, within the last three years
5. Any previous treatment with intravenous zoledronate or parathyroid hormone
6. Current treatment with nitrates
7. Any history of migraine headaches (nitrates can exacerbate migraines)
8. History of angina or cardiovascular disease
9. Inability to give informed consent
10. Hypersensitivity to nitroglycerin

Study & Design

• Study Type: Interventional
• Study Design: Not specified