Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT00054418
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2003-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002119', 'term': 'Calcium Carbonate'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D000068296', 'term': 'Risedronic Acid'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry', 'timeFrame': '1 year post study entry'}], 'secondaryOutcomes': [{'measure': 'Average intra-patient change in femoral neck and total hip BMD from baseline to one year after study entry', 'timeFrame': '1 year post study entry'}, {'measure': 'Incidence of osteopenia in the risedronate vs placebo groups at one year after study entry', 'timeFrame': '1 year post study entry'}, {'measure': 'Incidence of osteoporosis in the risedronate vs placebo groups at one year after study entry', 'timeFrame': '1 year post study entry'}, {'measure': 'Incidence of a 5% difference in intra-patient BMD scores at baseline', 'timeFrame': 'Baseline'}, {'measure': 'Serum and urine N-telopeptide and serum alkaline phosphatase at baseline and 6 months', 'timeFrame': 'Up to 6 months'}, {'measure': 'Frequency and severity of toxicity as measured by NCI CTC version 2.0', 'timeFrame': 'Up to 1 year post study treatment'}, {'measure': 'Menopausal symptoms as measured by the Greene Climacteric Scale (GCS) at baseline, monthly during chemotherapy, at 6 months, 1 year, and 2 years after study entry', 'timeFrame': 'Up to 2 years post study entry'}, {'measure': 'Association of baseline serum estradiol levels with permanent cessation of menses', 'timeFrame': 'Baseline'}, {'measure': 'Relationship between the subscales of the GCS (psychological, vasomotor, somatic and sexual) with type of chemotherapy, duration of chemotherapy, and menstrual cycle changes', 'timeFrame': 'Up to 2 years post study entry'}]}, 'conditionsModule': {'keywords': ['osteoporosis', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer'], 'conditions': ['Breast Cancer', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '19075260', 'type': 'RESULT', 'citation': 'Hines SL, Mincey BA, Sloan JA, Thomas SP, Chottiner E, Loprinzi CL, Carlson MD, Atherton PJ, Salim M, Perez EA. Phase III randomized, placebo-controlled, double-blind trial of risedronate for the prevention of bone loss in premenopausal women undergoing chemotherapy for primary breast cancer. J Clin Oncol. 2009 Mar 1;27(7):1047-53. doi: 10.1200/JCO.2008.19.1783. Epub 2008 Dec 15.'}, {'pmid': '38979716', 'type': 'DERIVED', 'citation': 'Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': '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.\n\nPatients are followed for 1 year. A summary of study goals is listed below.\n\nGoals:\n\n1. 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.\n2. 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.\n3. 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.\n4. To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Required Characteristics\n\n 1. Premenopausal women\n\n * ≤ 6 months since last menstrual period\n * no prior bilateral oophorectomy\n * not on estrogen replacement therapy\n * if TAH is performed, with at least one intact ovary, or if \\> 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry\n 2. Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB)\n 3. ≥ 18 years of age\n 4. ECOG performance status (PS) 0 or 1\n2. Contraindications\n\n 1. Hypercalcemia (calcium level \\> 1mg/dL above UNL ≤ 6 months\n 2. Hypocalcemia (calcium level \\> 0.5 mg/dL below UNL ≤ 6 months\n 3. Inability to stand or sit upright for at least 30 minutes\n 4. Known swallowing disorder\n 5. Bone mineral density T score of ≤ - 2.0 at the hip or lumbar spine\n\n * a patient with a T score of - 2.1 is ineligible\n * a patient with a T score of - 1.9 is eligible\n 6. History of vertebral compression fracture\n\n * Exception: traumatic fracture of the coccyx would not exclude a patient from participation\n 7. Corticosteroids at doses \\> 5 mg daily of prednison or equivalent for \\> 2 weeks in the past 6 months\n 8. Previous treatment with bisphosphonates\n 9. Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)\n 10. History of severe renal impairment or creatinine \\> 2.0 mg/dL\n 11. Malabsorption syndrome\n 12. Estrogen replacement therapy\n 13. Oral contraceptive use\n 14. Prior bilateral oophorectomy\n 15. Pregnant women\n\n * Nursing women\n * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device \\[IUD\\], surgical sterilization, abstinence, etc.)\n * This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown\n 16. Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment'}, 'identificationModule': {'nctId': 'NCT00054418', 'briefTitle': 'Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NCCTG-N02C1'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02515', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}, {'id': 'CDR0000270449', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'calcium carbonate, vitamin D and risedronate', 'description': 'Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.', 'interventionNames': ['Dietary Supplement: calcium carbonate', 'Dietary Supplement: vitamin D', 'Drug: risedronate sodium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'calcium carbonate, vitamin D and placebo', 'description': 'Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.', 'interventionNames': ['Dietary Supplement: calcium carbonate', 'Dietary Supplement: vitamin D', 'Other: placebo']}], 'interventions': [{'name': 'calcium carbonate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'calcium 600 mg daily administered orally for one year', 'armGroupLabels': ['calcium carbonate, vitamin D and placebo', 'calcium carbonate, vitamin D and risedronate']}, {'name': 'vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'vitamin D 400 U daily administered orally for one year', 'armGroupLabels': ['calcium carbonate, vitamin D and placebo', 'calcium carbonate, vitamin D and risedronate']}, {'name': 'risedronate sodium', 'type': 'DRUG', 'description': 'risedronate 35 mg weekly administered orally', 'armGroupLabels': ['calcium carbonate, vitamin D and risedronate']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo tablet weekly administered orally for one year', 'armGroupLabels': ['calcium carbonate, vitamin D and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Presbyterian Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301-9019', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80933', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose Cancer Center at Penrose Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Presbyterian - St. Luke's Medical Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rose Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80224-2522', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'CCOP - Colorado Cancer Research Program, Incorporated', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sky Ridge Medical Center', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '80502', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Hope Cancer Care Center at Longmont United Hospital', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '81004', 'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Mary-Corwin Regional Medical Center', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'zip': '80229', 'city': 'Thorton', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Suburban Medical Center'}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342-1611', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital Cancer Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342-1701', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Saint Joseph's Hospital of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'CCOP - Atlanta Regional', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MBCCOP-Medical College of Georgia Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30106', 'city': 'Austell', 'state': 'Georgia', 'country': 'United States', 'facility': 'WellStar Cobb Hospital', 'geoPoint': {'lat': 33.81261, 'lon': -84.63438}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Charles B. Eberhart Cancer Center at DeKalb Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30045', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Medical Center', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kennestone Cancer Center at Wellstar Kennestone Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30274-2600', 'city': 'Riverdale', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southern Regional Medical Center', 'geoPoint': {'lat': 33.57261, 'lon': -84.41326}}, {'zip': '60507', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush-Copley Cancer Care Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. Joseph Medical Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '61520', 'city': 'Canton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Graham Hospital', 'geoPoint': {'lat': 40.55809, 'lon': -90.03512}}, {'zip': '62321', 'city': 'Carthage', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 40.41643, 'lon': -91.13625}}, {'zip': '61530', 'city': 'Eureka', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eureka Community Hospital', 'geoPoint': {'lat': 40.72143, 'lon': -89.27286}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Clinic', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Cottage Hospital', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'InterCommunity Cancer Center of Western Illinois', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '62644', 'city': 'Havana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mason District Hospital', 'geoPoint': {'lat': 40.30004, 'lon': -90.06095}}, {'zip': '61747', 'city': 'Hopedale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hopedale Medical Complex', 'geoPoint': {'lat': 40.42087, 'lon': -89.41454}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology Hematology Associates, Limited - West', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '61443', 'city': 'Kewanee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Kewanee Hospital', 'geoPoint': {'lat': 41.24559, 'lon': -89.92483}}, {'zip': '61455', 'city': 'Macomb', 'state': 'Illinois', 'country': 'United States', 'facility': 'McDonough District Hospital', 'geoPoint': {'lat': 40.45921, 'lon': -90.6718}}, {'zip': '61265', 'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'facility': 'Trinity Medical Center - East', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'zip': '61265', 'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'BroMenn Regional Medical Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Community Cancer Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '61350', 'city': 'Ottawa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Community Hospital of Ottawa', 'geoPoint': {'lat': 41.34559, 'lon': -88.84258}}, {'zip': '61350', 'city': 'Ottawa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Hematology Associates of Central Illinois - 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