Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252421
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2005-11-10
Brief Title:
The Nitrate and Bone Study Effects of Nitrates on Osteoporosis
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
The Effects of Organic Nitrates on Osteoporosis Part 2
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoporosis or thinning of the bones affects in 1 in 4 Canadian women and 1 in 8 Canadian men Moreover while the rates of osteoporosis among Canadians are stabilizing worldwide the number of people afflicted with osteoporosis continues to rise The most serious complication of osteoporosis is a broken bone or fracture Fractures due to osteoporosis can result in long hospital stays dependence on others and premature death While there are several medications that prevent osteoporosis they all have side effects For example postmenopausal women who take hormone replacement therapy HRT are at increased risk of breast cancer and heart disease In addition drugs to prevent osteoporosis are expensive and not available worldwide Therefore it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis
The purpose of the research is to determine if nitrates a group of drugs that are widely available inexpensive and commonly used to treat chest pain or angina can prevent osteoporosis in women If the researchers find that nitrates prevent osteoporosis a widely available inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified This will improve the health of patients with osteoporosis worldwide
The purpose of the research is to determine if nitrates a group of drugs that are widely available inexpensive and commonly used to treat chest pain or angina can prevent osteoporosis in women If the researchers find that nitrates prevent osteoporosis a widely available inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified This will improve the health of patients with osteoporosis worldwide
Detailed Description:
This proposal consists of two studies The objective of the first study is to determine which of isosorbide mononitrate ISMO at 20 mgday or nitroglycerin ointment NTG at 15 mgday results in fewer headaches The nitrate that is best tolerated will be used in a second study with one main objective To determine if postmenopausal women with a T-score at the lumbar spine L1 to L4 between 0 and -20 randomized to two years of treatment with intermittent nitrates have a greater increase in spine BMD as compared to women randomized to placebo
We hypothesize that
1 Women will report fewer headaches when they are randomized to intermittent NTG ointment at 15 mgday compared to intermittent oral ISMO at 20 mgday
2 After two years women randomized to intermittent nitrates will have a greater percent increase in lumbar spine BMD compared with women randomized to placebo
To test these hypotheses we will execute 2 trials both of which include postmenopausal women aged 50 and older with BMD T scores at the lumbar spine between 0 and -20 We will exclude subjects with prior osteoporotic fractures or OP by BMD testing subjects with current metabolic bone or cardiovascular disease subjects taking treatments for OP subjects with migraine headaches and subjects with known hypersensitivity to nitrates We will use computer generated randomization to allocate subjects to treatment assignments To avoid bias the studies will be double-blind The first study which uses a crossover design will recruit 22 subjects who will be randomly assigned to each of NTG ointment and ISMO for one week In between treatments there will be a two week wash out period Subjects will rate headaches on a daily basis using a visual analog scale and for each subject I will calculate the mean headache score over the 7 day treatment period for both treatments We will then calculate the mean headache score considering all subjects for NTG and the mean headache score for ISMO We will compare the mean headache scores for both treatments and the nitrate preparation that is best tolerated lowest mean score will be used in a second placebo controlled study the main study whose primary objective is to assess the effects of intermittent nitrates on spine BMD L1 to L4 in 280 postmenopausal women To limit differential drop out due to headaches among subjects randomized to nitrates the main trial will follow a run-in phase during which all subjects will receive nitrates for one week Only those subjects who do not have headaches resulting in discontinuation of the study medication during the nitrate run-in phase will enter the main study
We hypothesize that
1 Women will report fewer headaches when they are randomized to intermittent NTG ointment at 15 mgday compared to intermittent oral ISMO at 20 mgday
2 After two years women randomized to intermittent nitrates will have a greater percent increase in lumbar spine BMD compared with women randomized to placebo
To test these hypotheses we will execute 2 trials both of which include postmenopausal women aged 50 and older with BMD T scores at the lumbar spine between 0 and -20 We will exclude subjects with prior osteoporotic fractures or OP by BMD testing subjects with current metabolic bone or cardiovascular disease subjects taking treatments for OP subjects with migraine headaches and subjects with known hypersensitivity to nitrates We will use computer generated randomization to allocate subjects to treatment assignments To avoid bias the studies will be double-blind The first study which uses a crossover design will recruit 22 subjects who will be randomly assigned to each of NTG ointment and ISMO for one week In between treatments there will be a two week wash out period Subjects will rate headaches on a daily basis using a visual analog scale and for each subject I will calculate the mean headache score over the 7 day treatment period for both treatments We will then calculate the mean headache score considering all subjects for NTG and the mean headache score for ISMO We will compare the mean headache scores for both treatments and the nitrate preparation that is best tolerated lowest mean score will be used in a second placebo controlled study the main study whose primary objective is to assess the effects of intermittent nitrates on spine BMD L1 to L4 in 280 postmenopausal women To limit differential drop out due to headaches among subjects randomized to nitrates the main trial will follow a run-in phase during which all subjects will receive nitrates for one week Only those subjects who do not have headaches resulting in discontinuation of the study medication during the nitrate run-in phase will enter the main 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 |
|---|---|---|---|
| ISRCTN 94484747 | None | None | None |