At a glance
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Nitrates and Bone Turnover (NABT): Trial to Select the Best Nitrate Preparation
In Brief
A Phase 3 clinical trial evaluating Nitrates (NABT Main trial) and Placebo for Osteoporosis. Completed, enrolled 265 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
nitroglycerin; isosorbide mononitrate
Placebo ointment