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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
265
nitroglycerin; isosorbide mononitrate
Placebo ointment
Women's College Research Institute/Women's College Hospital
Toronto, Ontario, Canada
Bone Turnover Markers
Markers of Bone Formation: * Serum Procollagen type 1 amino- terminal propeptide (P1NP) * Serum Osteocalcin (OC) * Serum Bone-specific alkaline phosphatase (BALP) Markers of Bone Resorption: \- Serum C-telopeptides of collagen cross-links (CTX)
Time frame: 3 months
Headache
Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from "0" to "10". A vertical line marked at "0" means no headache (score recorded = "0"), a vertical line marked at "10" means a terrible headache (score recorded = "10").
Time frame: Run-in phase - 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.