Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00043719|
Recruitment Status : Completed
First Posted : August 14, 2002
Last Update Posted : February 2, 2009
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 or disease||Intervention/treatment||Phase|
|Osteoporosis Osteopenia||Drug: Nitroglycerin ointment Drug: Calcium supplement with vitamin D||Phase 3|
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 (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Postmenopausal Bone Loss With Nitric Oxide|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|