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Bone Mineral Density in Postmenopausal Women at Increased Risk of Breast Cancer And Who Are Receiving Exemestane on MAP3

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ClinicalTrials.gov Identifier: NCT00688246
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Tracking Information
First Submitted Date May 30, 2008
First Posted Date June 2, 2008
Last Update Posted Date April 2, 2020
Actual Study Start Date January 23, 2008
Actual Primary Completion Date October 31, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2012)
Change in bone mineral density (BMD) as measured by dual x-ray absorptometry (DEXA) scans of the spine (L1-L4) and total hip 2 years after randomization [ Time Frame: 2 years ]
Original Primary Outcome Measures
 (submitted: May 30, 2008)
Change in bone mineral density (BMD) as measured by DEXA scans of the spine (L1-L4) and total hip 2 years after randomization
Change History
Current Secondary Outcome Measures
 (submitted: July 26, 2012)
  • Change in BMD as measured by DEXA scans of the spine (L1-L4) and total hip 5 years after randomization on CAN-NCIC-MAP3 [ Time Frame: 5 years ]
  • Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3 [ Time Frame: 5 years ]
  • Development of osteoporosis either by sustaining a fragility fracture or by having a BMD T-score at or lower than - 2.5 SD at the spine (L1-L4) or total hip [ Time Frame: 2 years ]
  • Number of clinical skeletal fractures by radiology report [ Time Frame: 2 years ]
Original Secondary Outcome Measures
 (submitted: May 30, 2008)
  • Change in BMD as measured by DEXA scans of the spine (L1-L4) and total hip 5 years after randomization on CAN-NCIC-MAP3
  • Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3
  • Development of osteoporosis either by sustaining a fragility fracture or by having a BMD T-score at or lower than - 2.5 SD at the spine (L1-L4) or total hip
  • Number of clinical skeletal fractures by radiology report
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Mineral Density in Postmenopausal Women at Increased Risk of Breast Cancer And Who Are Receiving Exemestane on MAP3
Official Title The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Brief Summary

RATIONALE: Learning about the effect of exemestane on bone mineral density in postmenopausal women at increased risk of breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably.

PURPOSE: This research study is measuring bone mineral density in postmenopausal women at increased risk of developing breast cancer who are receiving exemestane on clinical trial CAN-NCIC-MAP3.

Detailed Description

OBJECTIVES:

Primary

  • To assess the percentage change in bone mineral density (BMD) as measured by dual x-ray absorptometry (DEXA) scans of the spine (L1-L4) and total hip 2 years after randomization (and registration to the MAP.3B protocol).

Secondary

  • To assess the percentage change in BMD as measured by DEXA scans of the spine (L1-L4), and total hip 5 years after randomization (and registration to the MAP.3B protocol).
  • To compare the proportion of women who develop BMD of the spine (L1-L4) and total hip below the absolute threshold value for osteoporosis (T score ≤ -2.5 SD below the mean peak bone mass in young women) in the treatment groups.
  • To examine the pattern of changes in BMD parameters and bone biomarkers (i.e., PINP and NTx) over time and the impact of covariants using exploratory longitudinal analyses.
  • To compare the proportion of women who develop clinical skeletal fractures in the treatment groups.

OUTLINE: Patients undergo bone mineral density (BMD) measurement by dual x-ray absorptometry (DEXA). Blood specimens are collected at baseline and at 1 year, and 5 years and stored in a central laboratory for future assays of the bone biomarkers.

If the subject withdraws from the core MAP.3 study before 5 years, a bone density measurement and serum for bone biomarkers is obtained unless performed within the past 3 months. Patients may continue to be followed on the MAP.3 core study for fractures (and other MAP.3 study endpoints) for a minimum of 5 years after randomization.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum
Sampling Method Non-Probability Sample
Study Population Eligible women consenting to be randomized to the core MAP.3 trial will be approached for participation in this companion study. They must have an acceptable quality BMD scan by DEXA taken within 12 months prior to randomization to MAP.3. A BMD T-score > -2.0 SD (i.e. 2.0 standard deviations below the average peak BMD of a young adult woman) has been established as the study population cut-off because postmenopausal women who have BMD T-scores as low as or lower than - 2.0 SD are currently recommended to consider pharmacological therapies for their bones
Condition
  • Breast Cancer
  • Osteoporosis
Intervention
  • Other: biologic sample preservation procedure
    Increased bone turnover may be a risk factor for fracture [Lønning 2005]. However, it is uncertain whether markers of bone resorption and markers of bone formation are both associated with fracture risk [Looker 2000]. Therefore, we will measure bone formation and bone resorption markers at baseline, year 1 and year 5. Blood specimens will be shipped to and stored in a central laboratory for future assays of bone biomarkers. For markers of bone formation, the N-terminal Propeptide of Type I Collagen (PINP) will be measured. For bone resorption markers, serum levels of cross-linked N-telopeptides of type I collagen (NTx) will be measured. Note: Subjects must fast 12-14 hours prior to blood draw.
  • Procedure: dual x-ray absorptometry
    BMD of the spine (L1-L4) and total hip will be done within 12 months prior to randomization to the MAP.3 core protocol. BMD by DEXA of the spine (L1-L4) and total hip will be repeated at year 2 and year 5 of the MAP.3 core study on the same Lunar or Hologic scanner.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 30, 2011)
238
Original Enrollment
 (submitted: May 30, 2008)
480
Actual Study Completion Date January 10, 2013
Actual Primary Completion Date October 31, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • At increased risk of developing breast cancer and enrolled on clinical trial CAN-NCIC-MAP3
  • Bone mineral density (BMD) (as measured by dual x-ray absorptometry [DEXA] scans within 12 months prior to randomization to the core protocol [MAP.3]) T score > -2.0 standard deviation (i.e., 2.0 standard deviations below the average peak BMD of a young adult woman) of spine (L1-L4) and total hip
  • Serum for bone biomarkers (i.e., serum N-telopeptide and serum amino-terminal procollagen 1 extension peptide) must have been obtained within 8 weeks prior to registration to the study

PATIENT CHARACTERISTICS:

  • Postmenopausal, defined as one of the following:

    • Over 50 years of age with no spontaneous menses for at least 12 months before study entry
    • 50 years of age or under with no menses (spontaneous or secondary to hysterectomy) for at least 12 months before study entry AND with follicle-stimulating hormone level within postmenopausal range
    • Underwent prior bilateral oophorectomy
  • Available for collection of serum samples and BMD (DEXA) scans at the protocol defined times (i.e., have BMD scans at years 2 and 5 at the same site)
  • No history of fragility fractures (i.e., a broken bone that occurs with a fall from a standing height or lesser amount of trauma)
  • No malabsorption syndrome (e.g., untreated celiac disease, clinically relevant vitamin D deficiency, or active hyper- or hypoparathyroidism)
  • No Paget disease or other metabolic bone diseases (e.g., osteomalacia or osteogenesis imperfecta)
  • No Cushing disease or other pituitary diseases
  • No inflammatory disease(s) (e.g., inflammatory bowel disease, rheumatoid arthritis, lupus, psoriasic arthritis, ankylosing spondylitis, or autoimmune hepatitis)

PRIOR CONCURRENT THERAPY:

  • More than 3 months since prior bone drugs, such as bisphosphonates, teriparatide (parathyroid hormone [PTH]), sodium fluoride, calcitonin (Miacalcin®), strontium, or high-dose vitamin D (i.e., vitamin D3 > 2,000 IU/day or calcitriol)
  • No prior bisphosphonate therapy duration of more than 6 months total during lifetime
  • No concurrent anabolic or chronic oral corticosteroids (the equivalent of 5 mg of prednisone a day or higher for more than 2 weeks within the past 6 months and will likely require ongoing therapy)
  • Concurrent inhaled steroids allowed
  • No concurrent medication that may have an effect on study endpoints for this study, including any of the following:

    • Anticonvulsants
    • Sodium fluoride at daily doses > 5 mg/day for a period exceeding 1 month
    • Anabolic steroids
    • Teriparatide (parathyroid hormone)
    • Bisphosphonates, except for women who develop osteoporosis while on this study; these patients may be advised to start bone medication (i.e., strontium, calcitonin, or high-dose Vitamin D (i.e., Vitamin D3 > 2000 IU/day or calcitriol) at the discretion of their physician
Sex/Gender
Sexes Eligible for Study: Female
Ages 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00688246
Other Study ID Numbers MAP3B
CAN-NCIC-MAP3B ( Registry Identifier: NCI US - Physician Data Query )
PFIZER-NCIC-MAP3B ( Other Identifier: Pfizer )
CDR0000586285 ( Other Identifier: PDQ )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
Study Sponsor NCIC Clinical Trials Group
Collaborators Not Provided
Investigators
Study Chair: Paul E. Goss, MD, PhD Massachusetts General Hospital
PRS Account Canadian Cancer Trials Group
Verification Date March 2020