Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

January 29, 2009 updated by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Prevention of Postmenopausal Bone Loss With Nitric Oxide

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903-0019
        • UMDNJ-Robert Wood Johnson Medical School, Department of Medicine, Division of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
DXA-measured BMD (bone mineral density) of lumbar vertebrae (L2 to L4)

Secondary Outcome Measures

Outcome Measure
DXA-measured BMD of dual hips (Ward's triangle, femoral neck, and trochanter)
serum osteocalcin
BS-ALP
serum N-telopeptide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Sunil J. Wimalawansa, MD, PhD, UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

August 12, 2002

First Submitted That Met QC Criteria

August 13, 2002

First Posted (ESTIMATE)

August 14, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR048679 (NIH)
  • NIAMS-069
  • NOVEL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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