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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nitrol

Nitroglycerin Ointment 2% USP

Group Type ACTIVE_COMPARATOR

Nitrates (NABT Main trial)

Intervention Type DRUG

nitroglycerin; isosorbide mononitrate

Nitro-Dur

Nitroglycerin Extended Release Patch 160mg

Group Type ACTIVE_COMPARATOR

Nitrates (NABT Main trial)

Intervention Type DRUG

nitroglycerin; isosorbide mononitrate

Nitrostat 1

Nitroglycerin 0.3mg Sublingual Tablet

Group Type ACTIVE_COMPARATOR

Nitrates (NABT Main trial)

Intervention Type DRUG

nitroglycerin; isosorbide mononitrate

Nitrostat 2

Nitroglycerin 0.6mg Sublingual Tablet

Group Type ACTIVE_COMPARATOR

Nitrates (NABT Main trial)

Intervention Type DRUG

nitroglycerin; isosorbide mononitrate

ISMO

Isosorbide Mononitrate 20mg Oral Tablet

Group Type ACTIVE_COMPARATOR

Nitrates (NABT Main trial)

Intervention Type DRUG

nitroglycerin; isosorbide mononitrate

Placebo

Placebo Ointment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo ointment

Interventions

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Nitrates (NABT Main trial)

nitroglycerin; isosorbide mononitrate

Intervention Type DRUG

Placebo

Placebo ointment

Intervention Type OTHER

Other Intervention Names

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NABT-B Sub-Study: Nitroglycerin Ointment 2%: 15mg of NTG ointment for a 3 month period

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes