NCT00043719

Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

Prevention of Postmenopausal Bone Loss With Nitric Oxide

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DRUG	Nitroglycerin ointment
DRUG	Calcium supplement with vitamin D

Timeline

• Start date: 2002-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2002-08-14
• Last updated: 2009-02-02

Locations

1 site across 1 country: United States