Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006180
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2000-08-17
Brief Title:
Bone Loss in Premenopausal Women With Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The POWER STUDY Premenopause OsteopeniaOsteoporosis Women Alendronate Depression
Status:
COMPLETED
Status Verified Date:
2007-01-19
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:
The purpose of this study is to determine whether women with major depression lose bone mass at a faster rate than women without depression This study will also determine if the drug alendronate can maintain or increase bone mass in premenopausal women with major depression and osteoporosis
Depression may be a major risk factor for osteoporosis it is associated with abnormally elevated stress hormone levels that may contribute to bone loss This study will evaluate bone mass in women with depression and healthy volunteers
Participants will undergo psychiatric medical dietary and stress hormone evaluations and bone mineral density BMD measurements
Participants with depression will be divided into two groups those with normal BMD and those with low BMD Depressed participants with normal BMD will be compared to a control group of healthy premenopausal women with normal BMD and followed for 36 months Dual energy X-ray absorptiometry DEXA determinations will be made at months 6 12 24 and 36 bone turnover and endocrine parameters of depression will be
measured every 3 to 6 months
Participants with depression and low BMD will be randomly assigned to receive either alendronate or placebo an inactive pill once a week for 24 months Participants will receive calcium and vitamin D supplements daily DEXA determinations will be performed at screening and at Months 6 12 18 and 24 bone turnover and endocrine parameters of depression will be measured every 3 to 6 months
For both groups up to four of the visits may optimally be done as inpatient stays of two nights All remaining visits are as outpatients
Depression may be a major risk factor for osteoporosis it is associated with abnormally elevated stress hormone levels that may contribute to bone loss This study will evaluate bone mass in women with depression and healthy volunteers
Participants will undergo psychiatric medical dietary and stress hormone evaluations and bone mineral density BMD measurements
Participants with depression will be divided into two groups those with normal BMD and those with low BMD Depressed participants with normal BMD will be compared to a control group of healthy premenopausal women with normal BMD and followed for 36 months Dual energy X-ray absorptiometry DEXA determinations will be made at months 6 12 24 and 36 bone turnover and endocrine parameters of depression will be
measured every 3 to 6 months
Participants with depression and low BMD will be randomly assigned to receive either alendronate or placebo an inactive pill once a week for 24 months Participants will receive calcium and vitamin D supplements daily DEXA determinations will be performed at screening and at Months 6 12 18 and 24 bone turnover and endocrine parameters of depression will be measured every 3 to 6 months
For both groups up to four of the visits may optimally be done as inpatient stays of two nights All remaining visits are as outpatients
Detailed Description:
This is a five-year study on the natural history of bone turn-over in depressed premenopausal women ages 21 to 45 years with normal bone mass and the response to treatment with alendronate in depressed premenopausal women ages 21 to 45 with low bone mass as indicated by a bone mineral density BMD of negative 15 SD below peak bone mass at the spine andor hip Osteopenia is defined as a BMD at the spine andor hip that is between negative 15 and negative 25 SD osteoporosis is defined as a BMD that is below negative 25 SD at the spine andor hip During the initial screening the women are evaluated for depression Women who meet DSM-IV diagnostic criteria for Major Depressive Disorder as indicated by a structured psychiatric interview SCID-IV and HAM-D will then undergo a DEXA scan to determine BMD Participants will be divided into four subcategories based on BMD results Premenopausal depressed women with normal BMD less than negative 1 SD below the average peak bone mass at the spine andor hip Group B will be matched by age race and body mass index to a control group of healthy premenopausal non-depressed women with normal bone mass Group A Groups A and B will be followed for 12 months with DEXA determinations every 6 months measurements of bone turnover markers every 3 months measurements of relevant endocrine parameters every 3 months an exercise substudy at 0 6 and 12 months and collection of a DNA sample at one of the above visits
Women with depression and low BMD negative 15 SD below peak bone mass at the spine andor hip will enter a 12-month placebo-controlled clinical trial where they will be randomized either to blind alendronate 70 mg once a week Group C or blind placebo once a week Group D In addition to alendronate 70 mg once a week or placebo once a week women in Groups C and D will also receive daily 500 mg of elemental calcium and 400 IU of vitamin D DEXA determinations will be performed at Screening Month 0 Month 6 and Month 12 Determination of biochemical markers of bone turnover and endocrine parameters relevant to depression will be performed at 0 3 6 9 and 12 months An exercise substudy will be performed at 0 6 and 12 months The collection of a DNA sample will also be performed at one of the above visits
Women with depression and low BMD negative 15 SD below peak bone mass at the spine andor hip will enter a 12-month placebo-controlled clinical trial where they will be randomized either to blind alendronate 70 mg once a week Group C or blind placebo once a week Group D In addition to alendronate 70 mg once a week or placebo once a week women in Groups C and D will also receive daily 500 mg of elemental calcium and 400 IU of vitamin D DEXA determinations will be performed at Screening Month 0 Month 6 and Month 12 Determination of biochemical markers of bone turnover and endocrine parameters relevant to depression will be performed at 0 3 6 9 and 12 months An exercise substudy will be performed at 0 6 and 12 months The collection of a DNA sample will also be performed at one of the above visits
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 |
|---|---|---|---|
| 00-M-0203 | None | None | None |