Phase 3
Completed N=229
Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study
Source: ClinicalTrials.gov NCT01387672 ↗Enrolled (actual)
229
Serious AEs
0.9%
Results posted
May 2015
Primary outcomePrimary: Bone Turnover Markers — -4.627; -0.405; -4.297; -6.126 Percent change from baseline
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Turnover Markers |
-4.627; -0.405; -4.297; -6.126; 2.941; -1.635 | — |
| SECONDARY Headache |
2.1; 3.1; 1.5; 0.36; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
NABT:
- Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
- Women without a uterus will be eligible after age 55
NABT-B:
- Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
- Women without a uterus will be eligible after age 55
- Previously treated with alendronate but stopped within 2 years of study commencement; or previously treated with risedronate but stopped within 1 year of study commencement; or previously treated with zoledronate.
Exclusion Criteria
NABT:
- A previous fracture of the hip, wrist, spine or ankle within the last 3 months; or a diagnosis of osteoporosis;
- A history of bone disorders such as hyperparathyroidism or Paget's disease;
- Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater);
- Treatment with any antiresorptive agent, including alendronate, risedronate, etidronate or denosumab use for at least four weeks within the last three years;
- Previous treatment with intravenous zoledronate or parathyroid hormone;
- Current treatment with nitrates;
- A history of migraine headaches;
- A history of angina or cardiovascular disease;
- Inability to give informed consent;
- Hypersensitivity to nitroglycerin.
NABT-B:
- A previous fracture of the hip, wrist, spine or ankle; or a self-reported diagnosis of osteoporosis;
- A history of bone disorders such as hyperparathyroidism or Paget's disease;
- Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater);
- Treatment with etidronate or denosumab use for at least four weeks within the last three years and any previous treatment with parathyroid hormone;
- Current treatment with nitrates;
- A history of migraine headaches;
- A history of angina or cardiovascular disease;
- Inability to give informed consent;
- Hypersensitivity to nitroglycerin.
Data sourced from ClinicalTrials.gov (NCT01387672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.