Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00043719

Purpose

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	Intervention	Phase
Osteoporosis Osteopenia	Drug: Nitroglycerin ointment Drug: Calcium supplement with vitamin D	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prevention of Postmenopausal Bone Loss With Nitric Oxide

Resource links provided by NLM:

MedlinePlus related topics: Calcium Osteoporosis

Drug Information available for: Nitroglycerin Nitric oxide Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	July 2002
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043719

Locations

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)

Investigators

Principal Investigator:

Sunil J. Wimalawansa, MD, PhD

UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology

More Information

Additional Information:

The NOVEL Study: Nitroglycerin as an Option: Value in Early Bone Loss This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology ( Sunil J. Wimalawansa , MD, PhD )
Study ID Numbers:	R01 AR048679, NIAMS-069, NOVEL
Study First Received:	August 12, 2002
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00043719 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Human Female
Osteoporosis
Postmenopausal
Nitric Oxide

Nitroglycerin
Calcium
Vitamin D

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bone Density Conservation Agents
Bone Diseases
Nitroglycerin
Musculoskeletal Diseases
Vitamins
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors

Micronutrients
Growth Substances
Osteoporosis
Anti-Asthmatic Agents
Bone Diseases, Metabolic
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Nitric Oxide
Vitamin D
Autonomic Agents
Osteoporosis, Postmenopausal
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 27, 2009