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Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00043719
Recruitment Status : Completed
First Posted : August 14, 2002
Last Update Posted : February 2, 2009
Information provided by:

Study Description
Brief Summary:

Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. The purpose of this study is to determine the safety and effectiveness of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.

Study hypothesis: On average, participants in the base therapy cohort who receive placebo ointment control and calcium/vitamin D will lose more bone density than participants in the nitroglycerin cohort over the 36-month period.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Drug: Nitroglycerin ointment Drug: Calcium supplement with vitamin D Phase 3

Detailed Description:

Imbalance in the activities of osteoclasts (cells responsible for bone loss) and osteoblasts (cells responsible for bone formation) may lead to fractures, osteopenia, and osteoporosis in postmenopausal women. During postmenopause, decreased estrogen levels and decreased nitric oxide production occur; estrogen replacement therapy has been shown to restore serum nitric oxide levels to normal. Reversing nitric oxide deficiency by using nitroglycerin may prevent further bone loss. The Nitroglycerin as an Option: Value in Early Bone Loss (NOVEL) study will test the safety and efficacy of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.

Patients will be enrolled in the study for 3 years and will be randomly assigned to one of two groups. The first group will receive nitroglycerin ointment, while the second group will receive placebo ointment. All patients will be given a calcium supplement with vitamin D to be taken daily, and will be instructed to rub the given ointment on their skin daily. Study visits will occur at Month 2 and every six months after Month 2. Phone interviews will be conducted with patients every 2 months throughout the study.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prevention of Postmenopausal Bone Loss With Nitric Oxide
Study Start Date : July 2002
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. DXA-measured BMD (bone mineral density) of lumbar vertebrae (L2 to L4)

Secondary Outcome Measures :
  1. DXA-measured BMD of dual hips (Ward's triangle, femoral neck, and trochanter)
  2. serum osteocalcin
  3. BS-ALP
  4. serum N-telopeptide

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Postmenopausal for a minimum of 13 months
  • Lumbar spine T-score of 0 to -2.5 (0 to -2.0 if over 60 years old) by Dual Energy X-ray Absorptiometry (DEXA) (i.e., evidence of normal bone mass or osteopenia)
  • Body Mass Index (BMI) between 18 and 32
  • Planning to live in the greater New Brunswick, NJ, area for at least 3 years

Exclusion Criteria:

  • Radiographically or DEXA-morphometrically proven vertebral or hip fracture
  • Conditions requiring routine use of sublingual, transdermal, or oral nitrates
  • Significant postmenopausal symptoms that require estrogen therapy
  • Metabolic bone diseases other than postmenopausal bone loss (e.g., active hyperthyroidism, hyperparathyroidism, Paget's disease of bone, etc.)
  • Insulin-dependent diabetes mellitus
  • Significant migraine headaches
  • History of renal calculi
  • Cancer within 5 years prior to study entry
  • Any condition causing an anticipated life expectancy of less than 3 years
  • Failure to maintain 75% to 125% compliance with open-label calcium with vitamin D regimen during the screening period
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043719

United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School, Department of Medicine, Division of Endocrinology
New Brunswick, New Jersey, United States, 08903-0019
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Sunil J. Wimalawansa, MD, PhD UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology
More Information

Responsible Party: Sunil J. Wimalawansa , MD, PhD, UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology
ClinicalTrials.gov Identifier: NCT00043719     History of Changes
Other Study ID Numbers: R01AR048679 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2002    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Human Female
Nitric Oxide
Vitamin D

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Nitric Oxide
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents