Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Toronto
Collaborators:
California Pacific Medical Center Canadian Institutes of Health Research (CIHR) Sunnybrook Health Sciences Centre The Physicians' Services Incorporated Foundation