Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial CAN-NCIC-MA27

2014-08-27 03:43:27 | BioPortfolio


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.

PURPOSE: 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.



- 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.

OUTLINE: 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).

NOTE: *The lowest of the two T-scores: L1-L4 or total hip

Blood 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).

Patients receive oral calcium and oral cholecalciferol (vitamin D) daily. Patients with osteopenia or osteoporosis (stratum II) also receive oral bisphosphonate therapy (e.g., risedronate or alendronate).

PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.

Study Design

Primary Purpose: Diagnostic


Breast Cancer


calcium carbonate, calcium citrate, cholecalciferol, alendronate sodium, calcium gluconate, risedronate sodium, laboratory biomarker analysis, dual x-ray absorptometry


Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith
United States


Active, not recruiting


NCIC Clinical Trials Group

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:43:27-0400

Clinical Trials [2265 Associated Clinical Trials listed on BioPortfolio]

Efficacy of Calcium Citrate Versus Calcium Carbonate in Maintaining Normal Serum Calcium Level and Changing Quality of Life in Patients With Chronic Hypoparathyroidism

Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. According to the European guideline (2015), standard trea...

A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women

The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis

Cholecalciferol and Calcium Carbonate in Treating Patients With Colon Cancer That Has Been Removed by Surgery

RATIONALE: The use of cholecalciferol and calcium carbonate may keep colon cancer from coming back in patients with colon cancer that has been removed by surgery. PURPOSE: This randomized...

Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass

This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation. ...

Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate

Interventional Clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a ...

PubMed Articles [3835 Associated PubMed Articles listed on BioPortfolio]

Effect of Calcium Citrate versus Calcium Carbonate on elevated PTH after Roux-en-Y gastric bypass. A Double-blinded, Randomized Trial.

Following Roux-en-Y gastric bypass (RYGB), elevated parathyroid hormone (PTH) levels potentially harmful to bone health are commonly observed. Owing to assumed superior absorption, calcium citrate is ...

Impact of Potassium Citrate vs. Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers.

No medication has been shown to be effective at preventing recurrence of calcium phosphate urinary stones. Potassium citrate may protect against calcium phosphate stones by enhancing urine citrate exc...

L-thyroxine malabsorption due to calcium carbonate impairs blood pressure, total cholesterolemia, and fasting glycemia.

Calcium carbonate was previously shown to interfere with L-thyroxine absorption. To estimate the magnitude of tablet L-thyroxine malabsorption caused by calcium carbonate, with resulting increase in s...

Optimized Calcium Supplementation Approach for Regional Citrate Anticoagulation.

It has been confirmed that regional citrate anticoagulation (RCA) plays an effective role in extracorporeal anticoagulation. The current trial-and-error calcium supplementation approach, with intensiv...

Maximization of CO storage for various solvent types in indirect carbonation using paper sludge ash.

This study aimed to maximise the amount of CO storage by indirect carbonation using paper sludge ash (PSA), which is an alkaline industrial waste. The properties of the following three types of solven...

Medical and Biotech [MESH] Definitions

Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.

An electrogenic ion exchange protein that maintains a steady level of calcium by removing an amount of calcium equal to that which enters the cells. It is widely distributed in most excitable membranes, including the brain and heart.

Signal transduction mechanisms whereby calcium mobilization (from outside the cell or from intracellular storage pools) to the cytoplasm is triggered by external stimuli. Calcium signals are often seen to propagate as waves, oscillations, spikes, sparks, or puffs. The calcium acts as an intracellular messenger by activating calcium-responsive proteins.

Intracellular signaling peptides and proteins that bind to CALCIUM. They undergo allosteric changes when bound to CALCIUM that affects their interaction with other signal-transducing molecules. They differ from CALCIUM-SENSING RECEPTORS which sense extracellular calcium levels.

A class of G-protein-coupled receptors that react to varying extracellular CALCIUM levels. Calcium-sensing receptors in the PARATHYROID GLANDS play an important role in the maintenance of calcium HOMEOSTASIS by regulating the release of PARATHYROID HORMONE. They differ from INTRACELLULAR CALCIUM-SENSING PROTEINS which sense intracellular calcium levels.

More From BioPortfolio on "Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial CAN-NCIC-MA27"

Quick Search


Relevant Topics

Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial