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Completed

NCT Number: NCT01387672

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

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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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Headache Metabolic Diseases Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Toronto, Ontario, M5G 1N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitrates (NABT Main trial)

Drug

nitroglycerin; isosorbide mononitrate

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

Placebo

Other

Placebo ointment

Primary outcomes

  1. Bone Turnover Markers

    Time frame: 3 months

    Markers of Bone Formation:

    • Serum Procollagen type 1 amino- terminal propeptide (P1NP)
    • Serum Osteocalcin (OC)
    • Serum Bone-specific alkaline phosphatase (BALP)

    Markers of Bone Resorption:

    • Serum C-telopeptides of collagen cross-links (CTX)

Secondary outcomes

  1. Headache

    Time frame: Run-in phase - 2 days

    Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from "0" to "10". A vertical line marked at "0" means no headache (score recorded = "0"), a vertical line marked at "10" means a terrible headache (score recorded = "10").

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • California Pacific Medical Center
  • Canadian Institutes of Health Research (CIHR)
  • Sunnybrook Health Sciences Centre
  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Acronym: NABT;NABT-B

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2011
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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