Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | July 2002 |
| End Date: | December 2007 |
Prevention of Postmenopausal Bone Loss With Nitric Oxide
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.
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.
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.
(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.
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
We found this trial at
1
site
1 Robert Wood Johnson Place
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
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