Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054418
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2003-02-05
Brief Title:
Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Placebo-Controlled Double-Blind Trial Of Risedronate Actonel For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss
PURPOSE This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I stage II stage IIIA or stage IIIB breast cancer
PURPOSE This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I stage II stage IIIA or stage IIIB breast cancer
Detailed Description:
OUTLINE This is a randomized placebo-controlled double-blind study Patients are stratified according to planned tamoxifen therapy yes vs no vs undecided planned taxane therapy yes vs no vs undecided time from last menses 1-3 months vs longer than 3 months to 6 months and age under 40 vs 40 to 49 vs 50 and over Patients are randomized to 1 of 2 treatment arms In both arms treatment begins during the first month of chemotherapy and continues for 1 year in the absence of unacceptable toxicity For more information regarding the treatment arms please see the Arms section below Questionnaires about cessation of menses ovarian failure and menopausal symptoms are completed at baseline monthly during chemotherapy at 6 months and then at 1 and 2 years
Patients are followed for 1 year A summary of study goals is listed below
Goals
1 To evaluate the effectiveness of risedronate at a weekly oral dose of 35 mg versus placebo in the prevention of bone loss in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer
2 To evaluate the degree of bone loss over one year in premenopausal women undergoing adjuvant chemotherapy for primary breast cancer according to menopausal status at one year after therapy begins
3 To evaluate the relationship of current climacteric symptoms menstrual and reproductive history and chemotherapy regimen with ovarian failure permanent cessation of menses in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer
4 To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer
Patients are followed for 1 year A summary of study goals is listed below
Goals
1 To evaluate the effectiveness of risedronate at a weekly oral dose of 35 mg versus placebo in the prevention of bone loss in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer
2 To evaluate the degree of bone loss over one year in premenopausal women undergoing adjuvant chemotherapy for primary breast cancer according to menopausal status at one year after therapy begins
3 To evaluate the relationship of current climacteric symptoms menstrual and reproductive history and chemotherapy regimen with ovarian failure permanent cessation of menses in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer
4 To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer
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 |
|---|---|---|---|
| CDR0000270449 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02515 | REGISTRY | None | None |