Musculoskeletal Diseases

Nutritional and Metabolic Diseases

All Conditions

Wounds and Injuries

Eye Diseases

Digestive System Diseases

Osteoporosis

Fractures, Bone

Cataract

Gastrointestinal Diseases

Lens Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

The Swedish Mammography Cohort began in 1987-1990, when 66,651 women living in two counties in central Sweden completed a mailed questionnaire that included items about their diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education. Follow-up questionnaires have been sent out in 1997 and in 2008-09.

From 1987 to 1990 a population-based mammography screening program was introduced in two counties in central Sweden. In Västmanland County all women born between 1917 and 1948 received a mailed invitation to be screened by mammography between March 1987 and March 1989 (n=41,786) together with a 6-page questionnaire; 31,735 women (76%) returned the completed questionnaires. In Uppsala County all women born between 1914 and 1948 were invited to the screening and received the same questionnaire between January 1988 and December 1990 (n=48517); 34916 women (72%) returned the completed questionnaires. Hence, questionnaires completed before undergoing mammography were obtained from 66,651 women (74%) in the source population. These questionnaires included items about diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education.

In 1997 a second questionnaire was sent to all cohort members who were still living in the study area. The questionnaire updated information about diet and was extended to include information on physical activity, medical history, age at menarche, history of oral contraceptive use, age at menopause, postmenopausal hormone use and lifestyle factors such as cigarette smoking history and use of dietary supplements. Majority of questions in the questionnaires have been validated.

During 2008-09, the exposure information was updated and extended by sending out two new questionnaires - one questionnaire on health including several signs of symptoms, sleeping, social relations etc (2008) and one on diet, dietary supplement use, and lifestyle factors (2009).

Incident cases of cancer are ascertained by record linkages of the study population with the National Swedish Cancer Register and the Regional Cancer Registers. Cardiovascular and other diseases as well as surgeries and causes of death are identified by linkage to the National Inpatient and other registries at the Swedish Board of Health and Welfare. Ascertainment of cancer cases and other diseases is almost 100% complete. Dates of deaths are ascertained through the Swedish Death Register (100% complete), and information on date of moving out of the study area is obtained by linkage with the Swedish Population Register.

Swedish Mammography Cohort

Harvard School of Public Health (HSPH)

Karolinska Institutet

Professor

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anticoagulants

Bone Density Conservation Agents

Antineoplastic Agents

Other Dietary Supplements

Androgens

Citric Acid

Sodium Citrate

Toremifene

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Hormones

Hormone Antagonists

Citrate

Mitchell Steiner, MD

The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.

Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer

Phase III Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate 80 mg for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer on Androgen Deprivation Therapy

Ipsen

The Cohort of Swedish Men began in 1997, when all men born between 1918 and 1952 and residing in two counties in central Sweden received a questionnaire including about 350 items concerning diet and other lifestyle factors. A second questionnaire was sent out in 2008-09.

The Cohort of Swedish Men was established in 1997, when all men born between 1918 and 1952 and residing in Västmanland and Örebro counties in central Sweden received a questionnaire concerning diet and other lifestyle factors. Of the 100,303 eligible men, 48,850 (49%) responded to the questionnaire. The questionnaire included items about diet, physical activity, medical history, and lifestyle factors such as cigarette smoking history and use of dietary supplements.

During 2008-09, the exposure information was updated and extended by sending out two new questionnaires - one questionnaire on health including several signs of symptoms, sleeping, social relations etc (2008) and one on diet, dietary supplement use, and lifestyle factors (2009). Majority of questions in the questionnaires have been validated.

Incident cases of cancer are ascertained by record linkages of the study population with the National Swedish Cancer Register and the Regional Cancer Registers. Cardiovascular and other diseases as well as surgeries and causes of death are identified by linkage to the National Inpatient and other registries at the Swedish Board of Health and Welfare. Ascertainment of cancer cases and other diseases is almost 100% complete. Dates of deaths are ascertained through the Swedish Death Register (100% complete), and information on date of moving out of the study area is obtained by linkage with the Swedish Population Register.

Cohort of Swedish Men

Toremifene Citrate

Mitchell Steiner, M.D.

Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.

Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

Symptoms and General Pathology

Blood and Lymph Conditions

Neoplasm Metastasis

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Hematologic Diseases

Zoledronic Acid

Denosumab

Diphosphonates

Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC

zoledronic acid

Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes

denosumab

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer

Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.

Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.

Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.

This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

One subject who was randomized to zoledronic acid and received denosumab as the 1st investigational product was analyzed on the denosumab arm for safety analyses.

Zoledronic Acid 4 mg Q4W

Denosumab 120 mg Q4W

Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks

Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Swedish Mammography Cohort	NCT01127698	Cancers Cardiovascular ... Cataract Gastrointestina... Osteoporosis Fractures		40 Years - 74 Years	Karolinska Institutet
Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer	NCT01214291	Risk of Bone Fr...	Toremifene	50 Years - 80 Years	GTx
Cohort of Swedish Men	NCT01127711	Cancers Cardiovascular ... Cataract Gastrointestina... Osteoporosis Fractures		45 Years - 79 Years	Karolinska Institutet
Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer	NCT01214291	Risk of Bone Fr...	Toremifene	50 Years - 80 Years	GTx
Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy	NCT00129142	Prostate Cancer Osteoporosis Fractures	Toremifene Citr...	50 Years -	GTx
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer	NCT00321620	Bone Metastases	zoledronic acid denosumab	18 Years -	Amgen

Spots Global Cancer Trial Database for fractures

Every month we try and update this database with for fractures 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.

Spots Global Cancer Trial Database for fractures

Every month we try and update this database with for fractures 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 fractures 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.