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Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

2014-08-27 03:55:52 | BioPortfolio

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.

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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Osteoporosis

Intervention

Nitroglycerin ointment, Calcium supplement with vitamin D

Location

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

Status

Completed

Source

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

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:52-0400

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Medical and Biotech [MESH] Definitions

Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.

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Calcium compounds used as food supplements or in food to supply the body with calcium. Dietary calcium is needed during growth for bone development and for maintenance of skeletal integrity later in life to prevent osteoporosis.

A protein that plays a fundamental role in the Vitamin D mediated transport of calcium in reptiles, amphibians, birds and mammals. It is found in the intestine, kidneys, egg shell gland, brain, and possibly other organs. Its molecular weight is species dependent.

A vitamin that includes both CHOLECALCIFEROLS and ERGOCALCIFEROLS, which have the common effect of preventing or curing RICKETS in animals. It can also be viewed as a hormone since it can be formed in SKIN by action of ULTRAVIOLET RAYS upon the precursors, 7-dehydrocholesterol and ERGOSTEROL, and acts on VITAMIN D RECEPTORS to regulate CALCIUM in opposition to PARATHYROID HORMONE.

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