Know Cancer

or
forgot password

The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer


N/A
35 Years
N/A
Not Enrolling
Female
Breast Cancer, Osteoporosis

Thank you

Trial Information

The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Paul E. Goss, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

Canada: Health Canada

Study ID:

MAP3B

NCT ID:

NCT00688246

Start Date:

January 2008

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • breast cancer
  • Breast Neoplasms
  • Osteoporosis

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Fletcher Allen Health CareBurlington, Vermont  05401
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of OklahomaOklahoma City, Oklahoma  73190
Suburban Hospital Cancer ProgramBethesda, Maryland  20817
Los Angeles Biomedical Research InstituteTorrance, California  90502
The George Washington UniversityWashington, District of Columbia  20037
Hutzel Women's Health SpecialistsDetroit, Michigan  48201
The Memorial Hospital of Rhode IslandPawtucket, Rhode Island  02860
Univ. of Wisconsin Center for Women's Health andMadison, Wisconsin  53715