Neoplasms

Digestive System Diseases

All Conditions

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Osteoporosis

Carcinoma, Squamous Cell

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Bone Density Conservation Agents

All Drugs and Chemicals

Channel Blockers

Etidronic Acid

Alendronate

Raloxifene Hydrochloride

Ibandronic Acid

Risedronic Acid

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Participants with any United Kingdom General Practice Research Database (GPRD) Medical code for esophageal cancer (cases). Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.

Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.

Participants who did not initiate treatment of osteoporosis with a study drug

Participants initiating treatment for osteoporosis with alendronate

Participants initiating treatment for osteoporosis with etidronate

Participants initiating treatment for osteoporosis with ibandronate

Participants initiating treatment for osteoporosis with risedronate

Participants initiating treatment for osteoporosis with raloxifene

Etidronate

Ibandronate

Risedronate

Raloxifene

Alec Walker, MD, DrPH

This is a 2-phase retrospective database study, using both case-cohort and inception (intention-to-treat) cohort analyses to evaluate any association between oral treatments for osteoporosis and the risk of esophageal cancer in women.

Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)

The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women

To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.

To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used.

World Health Information Science Consultants, LLC

Organon and Co

Adverse events were not collected during this study.

Overall Study Population

≥55

Age, Customized

Sex: Female, Male

Senior Vice President, Global Clinical Development

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.

A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.

Participants with any GPRD Medical Code for esophageal cancer (cases).

Esophageal Cancer Cohort

Comparison Sample (Case Cohort)

Case-Cohort analysis population came from the Overall Study Population and comprised 929 women with esophageal cancer (cases) and a Comparison Sample of 338,911 matched control women. Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.

Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate

compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate

compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate

compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate

compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene

compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only

esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,

only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,

only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of

raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only

esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate

compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate

compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate

compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene

compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used.

Participants who did not initiate osteoporosis treatment with a study drug

Comparators

Participants who initiated osteoporosis treatment with alendronate

Participants who initiated osteoporosis treatment with etidronate

Participants who initiated osteoporosis treatment with ibandronate

Participants who initiated osteoporosis treatment with risedronate

Risendronate

Participants who initiated osteoporosis treatment with raloxifene

Inception Cohort came from the Overall Study Population beginning treatment with an osteoporosis study drug (initiators, 78,630 women) and 300,610 matched control women, who did not receive study drug (noninitiators). Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.

Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Diphosphonates

Subjects will take the study drug alendronate, a nitrogenous bisphosponate, for approximately one to three weeks before their breast surgery.

10 mg (1 tablet) once daily for 1-3 weeks before breast surgery; drug will be discontinued the day before surgery.

Lee Wilke

The goal of this study is to mechanistically define the potential anticancer activities of the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn novel information about the impact of BP on gamma delta (γδ) T cells in breast tissues as well as epithelial breast cell differentiation of high-risk women. To this end, we have designed a BP "window trial" to examine the effect of 1 - 3 weeks administration of alendronate on women at high-risk for breast cancer, at the level of immunosurveillance and mammary epithelial cell differentiation.

Pilot Study of Bisphosphonates for Breast Cancer

Pilot Clinical Trial of Short-Term Bisphosphonate Administration as Chemoprevention for Breast Cancer Via Engagement of γδ T Cells

The effect of alendronate will be assessed using a one-tailed one-sample paired t-test or Wilcoxon signed rank test at a significance level of 0.10.

γδ T cell infiltration and activation as defined by the presence and increase in percentage of γδ T cells in the CNB sample following study agent (alendronate) administration. The effect of alendronate will be assessed using a one-tailed one-sample paired t-test or Wilcoxon signed rank test at a significance level of 0.10.

Wisconsin Partnership Program

University of Wisconsin, Madison

Placebo

Ting Fan Leung, MBChB, MD

Patrick MP Yuen, MD, FRCPC

Chi Kong Li, MBBS, MD

Christopher WK Lam, PhD

Vincent Lee, MBChB

Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.

The modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. Despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. Our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (BMD) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. This landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. Thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. In this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve BMD over a 36-week period in long-term survivors of childhood cancers in Hong Kong. In addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin D) and calcium carbonate throughout the whole study period. The study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)	NCT01077817	Esophageal Canc... Squamous Cell C... Adenocarcinoma	Alendronate Etidronate Ibandronate Risedronate Raloxifene	55 Years -	Organon and Co
Pilot Study of Bisphosphonates for Breast Cancer	NCT02781805	Breast Neoplasm...	Alendronate	18 Years -	University of Wisconsin, Madison
Fosamax for Childhood Cancer Survivors	NCT00391404	Osteoporosis	Alendronate Placebo	15 Years -	Chinese University of Hong Kong
Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)	NCT01077817	Esophageal Canc... Squamous Cell C... Adenocarcinoma	Alendronate Etidronate Ibandronate Risedronate Raloxifene	55 Years -	Organon and Co
Fosamax for Childhood Cancer Survivors	NCT00391404	Osteoporosis	Alendronate Placebo	15 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for alendronate

Every month we try and update this database with for alendronate cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for alendronate

Every month we try and update this database with for alendronate cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for alendronate cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.