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Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study

Nitrates and Bone Turnover (NABT): Trial to Select the Best Nitrate Preparation

NCT01387672•University of Toronto

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.

Eligibility

Age

50 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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;
+11 more criteria

Locations (1)

Women's College Research Institute/Women's College Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

September 1, 2011

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

May 8, 2015

Enrollment

265

ACTUAL participants

Conditions

Osteoporosis

Interventions

Nitrates (NABT Main trial)

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study

Inclusion Criteria

Exclusion Criteria

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