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Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women Clinical research trials and Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women. Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women clinical trial. Subjects typically recieve the finest healthcare available for their Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "N" Clinical Trials Conditions > Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women  Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
For Condition: Osteopenia,Osteoporosis
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/65 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
SunilWimalawansa, Principal Investigator, UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology
UMDNJ-Robert Wood Johnson Medical School, Department of Medicine, Division of Endocrinology *Recruiting*
New Brunswick, New Jersey, 08903-0019
United States
Recruiting Genevieve Rojo 732-235-6639
Additional Information:
Study ID Numbers: NIAMS-069; NOVEL,R01 AR48679
Study Start Date: July 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043719
Other Osteoporosis Studies:
1. Once Weekly Parathyroid Hormone for Osteoporosis
2. Effects of Low-Dose Doxycycline on Oral Bone Loss
3. Electromagnetic Treatment For Bone Loss After Forearm Fracture
4. Encouraging Calcium Absorption and Bone Formation During Early Puberty
5. Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
Related Studies:
Other Osteoporosis Clinical Trials
Other New Jersey Clinical Trials
Other New Brunswick Clinical Trials
Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
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