Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00354302
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2006-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'United States']}, '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': 'D019355', 'term': 'Calcium Citrate'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D002125', 'term': 'Calcium Gluconate'}, {'id': 'D000068296', 'term': 'Risedronic Acid'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}], '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': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D005942', 'term': 'Gluconates'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 497}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2006-07-19', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Percentage change in BMD at 5 years (from baseline)', 'timeFrame': '5 years'}, {'measure': 'Mean percentage change in BMD at 1, 3, and 5 years (from baseline)', 'timeFrame': '5 years'}, {'measure': 'Proportion of patients without osteopenia or osteoporosis (stratum I) who develop BMD below the absolute threshold for osteopenia (< -2.0 standard deviation below the mean), suffer any osteoporotic fracture, or have an asymptomatic fracture revealed ...', 'timeFrame': '5 years'}, {'measure': 'Percentage of patients with osteopenia or osteoporosis (stratum II) who have ≥ 5% improvement of BMD at 2 years post randomization on protocol CAN-NCIC-MA27 and who have clinically apparent osteoporosis-related fracture of the long bones', 'timeFrame': '5 years'}, {'measure': 'Pattern of change in bone biomarkers from baseline', 'timeFrame': '5 years'}, {'measure': 'Clinical safety and tolerability of study medications', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoporosis', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer'], 'conditions': ['Breast Cancer', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '24636210', 'type': 'RESULT', 'citation': 'Goss PE, Hershman DL, Cheung AM, Ingle JN, Khosla S, Stearns V, Chalchal H, Rowland K, Muss HB, Linden HM, Scher J, Pritchard KI, Elliott CR, Badovinac-Crnjevic T, St Louis J, Chapman JA, Shepherd LE. Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial. Lancet Oncol. 2014 Apr;15(4):474-82. doi: 10.1016/S1470-2045(14)70035-X. Epub 2014 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably.\n\nPURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether there is a clinically relevant difference in bone mineral density (BMD) at 2 years in postmenopausal women with primary breast cancer (with or without osteopenia or osteoporosis) treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27.\n\nOUTLINE: This is a multicenter, companion study. Patients are stratified according to baseline bone mineral density (BMD) measurement (T-score\\* ≥ -2.0 standard deviation \\[SD\\] \\[no osteopenia or osteoporosis\\] vs T-score\\* \\< -2.0 SD).\n\nNOTE: \\*The lowest of the two T-scores: L1-L4 or total hip\n\nBlood samples for the identification of bone biomarkers (formation marker: serum amino-terminal procollagen 1 extension peptide \\[P1NP\\] and resorption marker: serum N-telopeptide) are obtained at baseline and at 6 and 12 months. BMD is determined by dual-energy x-ray absorptiometry (DEXA) at baseline and then annually for 5 years (or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27).\n\nPatients receive oral calcium and oral cholecalciferol (vitamin D) daily. Patients with osteopenia or osteoporosis (stratum II) also receive oral bisphosphonate therapy\n\nPROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Enrolled in and meets eligibility requirements for protocol CAN-NCIC-MA27\n* Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L1-L4 postero-anterior spine and hip within 12 weeks prior to randomization on protocol CAN-NCIC-MA27\n* Hormone receptor status:\n\n * Estrogen receptor- and/or progesterone receptor-positive tumor\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Postmenopausal\n* No malabsorption syndrome\n* No known cholecalciferol (vitamin D) deficiency, active hyper- or hypoparathyroidism, or Paget's disease\n* No uncontrolled thyroid disease, Cushing's disease, or other pituitary disease\n* No other bone disease (including osteomalacia or osteogenesis imperfecta)\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 6 months since prior drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (stratum I)\n* More than 12 months since prior and no concurrent anticonvulsants\n* More than 6 months since prior and no concurrent corticosteroids at doses \\> 5 mg/day of prednisone (or equivalent) for \\> 2 weeks\n* More than 12 months since prior and no concurrent anabolic steroids\n* No prior bisphosphonates (stratum II)\n* No concurrent sodium fluoride at daily doses ≥ 5 mg/day\n* No long-term (i.e., \\> 6 months) use of coumarins\n* No concurrent drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (for patients with no osteopenia or osteoporosis \\[stratum I\\])"}, 'identificationModule': {'nctId': 'NCT00354302', 'briefTitle': 'Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer', 'orgStudyIdInfo': {'id': 'MA27B'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-MA27B', 'type': 'REGISTRY', 'domain': 'National Cancer Institute - Physician Data Query'}, {'id': 'SWOG-NCIC-MA27B', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'NCCTG-NCIC-MA27B', 'type': 'OTHER', 'domain': 'NCCTG'}, {'id': 'CAN-NCIC-BONE'}, {'id': 'CDR0000483099', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'calcium carbonate', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'calcium citrate', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'cholecalciferol', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'alendronate sodium', 'type': 'DRUG'}, {'name': 'calcium gluconate', 'type': 'DRUG'}, {'name': 'risedronate sodium', 'type': 'DRUG'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'dual x-ray absorptometry', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E1C 6Z8', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'The Moncton Hospital', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Atlantic Health Sciences Corporation', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'N1R 3G2', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cambridge Memorial Hospital', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'P6B 0A8', 'city': 'Sault Ste. Marie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Algoma District Cancer Program', 'geoPoint': {'lat': 46.51677, 'lon': -84.33325}}, {'zip': 'P7B 6V4', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Thunder Bay Regional Health Science Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Univ. Health Network-Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Charles LeMoyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHA-Hopital Du St-Sacrement', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S4T 7T1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}], 'overallOfficials': [{'name': 'Paul E. Goss, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'James N. Ingle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}, {'name': 'Dawn Hershman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'North Central Cancer Treatment Group', 'class': 'NETWORK'}, {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}