Conditions: Osteoporosis
Keywords: postmenopausal osteoporosis bone turnover nitrate headache
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Nitroglycerin Ointment 2% USP arm 2: Nitroglycerin Extended Release Patch 160mg arm 3: Nitroglycerin 0.3mg Sublingual Tablet arm 4: Nitroglycerin 0.6mg Sublingual Tablet arm 5: Isosorbide Mononitrate 20mg Oral Tablet arm 6: Placebo Ointment

Interventions: intervention 1: Nitrates (NABT Main trial) intervention 2: Placebo
Intervention descriptions: intervention 1: nitroglycerin; isosorbide mononitrate intervention 2: Placebo ointment

Protocol document: