Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043719
Status:
COMPLETED
Last Update Posted:
2009-02-02
First Post:
2002-08-12
Brief Title:
Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Prevention of Postmenopausal Bone Loss With Nitric Oxide
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 calciumvitamin D will lose more bone density than participants in the nitroglycerin cohort over the 36-month period
Study hypothesis On average participants in the base therapy cohort who receive placebo ointment control and calciumvitamin 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NOVEL | None | None | None |
| NIAMS-069 | None | None | None |