Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Prostatic Neoplasms

Osteoporosis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Micronutrients

Gastrointestinal Agents

Channel Blockers

Vitamins

Androgens

Estrogens, Conjugated (USP)

Estrogens

Vitamin D

Cholecalciferol

Calcium

Calcium Carbonate

Calcium, Dietary

Risedronic Acid

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Trace Elements

Hormone Antagonists

Antacids

Anti-Ulcer Agents

Calcium Channel Blockers

Vitamin D3

Calciferol

Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.

Treatment in all arms continues for 2 years.

Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.

Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.

Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.

Treatment in all arms continues for 2 years.

Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.

Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.

Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.

Treatment in all arms continues for 2 years.

Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.

Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.

Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.

Treatment in all arms continues for 2 years.

Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.

Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.

calcium carbonate

cholecalciferol

risedronate sodium

placebo

Charles L. Loprinzi, MD

RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis.

PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.

OBJECTIVES:

* Compare the change in bone mineral density in patients with prostate cancer who are receiving androgen-ablation therapy treated with calcium and cholecalciferol with or without conjugated estrogens and with or without risedronate.
* Compare the toxicity of these regimens in these patients.
* Compare the changes in bone markers in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Compare hot flashes in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to duration of therapy with luteinizing hormone-releasing hormone agonists (no more than 30 days vs 31 to 150 days vs 151 to 365 days vs more than 365 days). Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.
* Arm II: Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.
* Arm III: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.
* Arm IV: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.

Treatment in all arms continues for 2 years.

Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.

Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.

PROJECTED ACCRUAL: A total of 282 patients (70 per treatment arm) will be accrued for this study within 14 months.

Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer

Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.

Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.

calcium 600 mg daily administered orally for one year

vitamin D 400 U daily administered orally for one year

vitamin D

risedronate 35 mg weekly administered orally

placebo tablet weekly administered orally for one year

Stephanie Hines, MD

RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss.

PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to planned tamoxifen therapy (yes vs no vs undecided), planned taxane therapy (yes vs no vs undecided), time from last menses (1-3 months vs longer than 3 months to 6 months), and age (under 40 vs 40 to 49 vs 50 and over). Patients are randomized to 1 of 2 treatment arms. In both arms, treatment begins during the first month of chemotherapy and continues for 1 year in the absence of unacceptable toxicity. For more information regarding the treatment arms, please see the "Arms" section below. Questionnaires about cessation of menses, ovarian failure, and menopausal symptoms are completed at baseline, monthly during chemotherapy, at 6 months, and then at 1 and 2 years.

Patients are followed for 1 year. A summary of study goals is listed below.

Goals:

1. To evaluate the effectiveness of risedronate at a weekly oral dose of 35 mg versus placebo in the prevention of bone loss in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
2. To evaluate the degree of bone loss over one year in premenopausal women undergoing adjuvant chemotherapy for primary breast cancer according to menopausal status at one year after therapy begins.
3. To evaluate the relationship of current climacteric symptoms, menstrual and reproductive history, and chemotherapy regimen with ovarian failure (permanent cessation of menses) in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
4. To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.

Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer

A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma

Wounds and Injuries

Fractures, Bone

Fractures, Open

Antineoplastic Agents

Anastrozole

Diphosphonates

Antineoplastic Agents, Hormonal

Aromatase Inhibitors

Enzyme Inhibitors

High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum

Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum

Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum

Risedronate Sodium

AstraZeneca Arimidex Medical Science Director, MD

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated

AstraZeneca

Francisco Sapunar, MD - Arimidex Medical Science Director

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer	NCT00043069	Osteoporosis Prostate Cancer	calcium carbona... cholecalciferol Estrogen Antago... risedronate sod... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer	NCT00054418	Breast Cancer Osteoporosis	calcium carbona... vitamin D risedronate sod... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer	NCT00043069	Osteoporosis Prostate Cancer	calcium carbona... cholecalciferol Estrogen Antago... risedronate sod... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer	NCT00082277	Breast Cancer	Anastrozole Risedronate Sod...	55 Years -	AstraZeneca

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