NCT01387672

Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study

Nitrates and Bone Turnover (NABT): Trial to Select the Best Nitrate Preparation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

Purpose: NABT: To compare five widely available nitrate formulations: (1) 15 of nitroglycerin (NTG) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual NTG, (4) 20 mg of isosorbide mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch), for their efficacy on markers of bone formation and resorption and for the incidence and severity of headache they cause. Hypothesis: There is one ideal nitrate preparation which balances the clinical efficacy in bone remodeling against the common side effect of headache. NABT-B: To determine if nitrates affect markers of bone formation (serum BALP and P1NP) and resorption (serum CTX and urine NTX) in women who have recently discontinued treatment with alendronate, risedronate or zoledronate.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Nitrates (NABT Main trial)	nitroglycerin; isosorbide mononitrate
OTHER	Placebo	Placebo ointment

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-07-04
• Last updated: 2015-05-08
• Results posted: 2015-05-08

Locations

1 site across 1 country: Canada