Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
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.
|Osteoporosis Osteopenia||Drug: Nitroglycerin ointment Drug: Calcium supplement with vitamin D||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Prevention of Postmenopausal Bone Loss With Nitric Oxide|
- DXA-measured BMD (bone mineral density) of lumbar vertebrae (L2 to L4)
- DXA-measured BMD of dual hips (Ward's triangle, femoral neck, and trochanter)
- serum osteocalcin
- serum N-telopeptide
|Study Start Date:||July 2002|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Sunil J. Wimalawansa, MD, PhD||UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology|