Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Bone Density Conservation Agents

Channel Blockers

All Drugs and Chemicals

Risedronic Acid

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Risedronate 150 mg given once 7-21 days prior to initiation of SBRT

Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT

Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT

risedronate

Dose not applicable, given once 7-21 days prior to initiation of SBRT

Matching placebo

Michael Farris, MD

This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation.

Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks.

All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.

2.1 Primary Objective(s)

The primary objective is to assess the percent change in bone mean cortical thickness within regions of bone receiving 30 Gy or more at 3 months after SBRT. The % change in mean cortical thickness will be compared between patients who received risedronate and those who received placebo.

2.2 Secondary Objective(s)

In addition to the primary objective, the investigators will further analyze the remaining routine follow-up chest CT scans, for mean cortical thickness change in regions of bone that received 0 - 10 Gy, \>10 - 20 Gy, \> 20 - 30 Gy, \> 30 - 40 Gy, and \> 40 Gy at all time points including 3 months, 6 months, 9 months, and 12 months. These scans are standard of care and would be performed regardless of inclusion on this trial. This will allow us to determine the potential persistence of effects from SBRT and bisphosphonate use.

The investigators will assess and compare the incidence and grade (per modified CTCAE v.5) of radiation induced chest wall pain within the radiation treatment portal (within the 50% isodose line) at time of each routine follow up visit (3 months, 6 months, 9 months, and 12 months post SBRT). The purpose of utilizing a placebo and double-blind design is that chest wall pain is a subjective finding. Furthermore, it is unclear if chest wall pain from radiation is directly due to bone damage, nerve damage, muscle irritation, or a combination of all of these factors. The use of placebo will help us reduce the potential for bias in pain assessment.

The investigators will assess and compare the incidence of rib and vertebral fractures (as noted on CT imaging) that occur within 12 months of irradiation and are within the radiation treatment field. The radiation treatment field will be defined as within the 50% isodose line.

The urine concentration of an osteoclast-specific biomarker, urinary N-telopeptide (NTX) indicating osteoclast activity will be assessed prior to SBRT and at each routine follow up visit (at 3 months, 6 months, 9 months, and 12 months post SBRT).

Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT

A Randomized Clinical Trial of Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT

The primary outcome measure is the percent change in mean cortical thickness (C.Th) of bones receiving 30 Gy or more at 3 months post SBRT, when compared to pre-SBRT cortical thickness

The percent change in mean C.Th of bones will be assessed in regions of bone that received 0 - 10 Gy, \>10 - 20 Gy, \> 20 - 30 Gy, \> 30 - 40 Gy, and \> 40 Gy at all time points including 3 months, 6 months, 9 months, and 12 months.

Chest wall pain incidence and grade will be collected as per modified CTCAE v. 5 within the within the 50% isodose line. Appendix K. Below we report numbers with any chest wall pain of grades 3+ over the year of followup.

Incidence of rib and vertebral fractures (as noted on CT imaging) that occur within 12 months of irradiation and are within the within 50% isodose line.

The urine concentration of an osteoclast-specific biomarker, urinary N-telopeptide (U-NTX) indicating osteoclastic activity will be assessed prior to SBRT and at each routine follow up visit (at 3 months, 6 months, 9 months, and 12 months post SBRT).

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Risedronate 150 mg given once 7-21 days prior to initiation of SBRT

risedronate: Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT

Risedronate

Matching placebo, dose not applicable given once 7-21 days prior to initiation of SBRT

Matching placebo: Dose not applicable, given once 7-21 days prior to initiation of SBRT

Matching Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Biostatistician

A small number of participants who were enrolled were not able to have cortical thickness determined at 3 months.

Changes in Mean Cortical Thickness

% change cort thickness in region <10 Gy--time 3mo to bl

% change cort thickness in region <10 Gy--time 6mo to bl

% change cort thickness in region <10 Gy--time 9mo to bl

% change cort thickness in region <10 Gy--time 12mo to bl

% change cort thickness in region 10-20 Gy--time 3mo to bl

% change cort thickness in region 10-20 Gy--time 6mo to bl

% change cort thickness in region 10-20 Gy--time 9mo to bl

% change cort thickness in region 10-20 Gy--time 12mo to bl

% change cort thickness in region 20-30 Gy--time 3mo to bl

% change cort thickness in region 20-30 Gy--time 6mo to bl

% change cort thickness in region 20-30 Gy--time 9mo to bl

% change cort thickness in region 20-30 Gy--time12mo to bl

% change cort thickness in region 30-40 Gy--time 3mo to bl

% change cort thickness in region 30-40 Gy--time 6mo to bl

% change cort thickness in region 30-40 Gy--time 9mo to bl

% change cort thickness in region 30-40 Gy--time12mo to bl

% change cort thickness in region >30 Gy--time 3mo to bl

% change cort thickness in region >30 Gy--time 6mo to bl

% change cort thickness in region >30 Gy--time 9mo to bl

% change cort thickness in region >30 Gy--time 12mo to bl

% change cort thickness in region >40 Gy--time 3mo to bl

% change cort thickness in region >40 Gy--time 6mo to bl

% change cort thickness in region >40 Gy--time 9mo to bl

% change cort thickness in region >40 Gy--time 12mo to bl

A small number of participants did not have follow-up cortical thickness measures.

4 Time Points Assessing Change in Mean Cortical Thickness of Bones

Some participants did not have sufficient self-reported symptom pain data to determine if, over course of 12 months, they had any chest wall pain of grade 3 or higher

Number of Participants With Chest Wall Pain

For a small number of participants it was not possible to determine clearly if a fracture had occurred within 12 months.

Number of Participants With Rib and Vertebral Fracture

Urinary NTX values at BL

Urinary NTX values at 3mo

Urinary NTX values at 6mo

Urinary NTX values at 9mo

Urinary NTX values at 12mo

A small number of participants did not have urine samples analyzed.

Urine Concentration at 4 Time Points

Overall Study

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Breast Diseases

Skin Diseases

Metabolic Diseases

Menopause

Micronutrients

Vitamins

Vitamin D

Cholecalciferol

Aromatase Inhibitors

Diphosphonates

Vitamin D3

Calciferol

Patients receive placebo 35 mg once a week plus a calcium and vitamin D supplementation.

Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment

Patients receive risedronate 35 mg once a week plus a calcium and vitamin D supplementation.

Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment

35mg oral risedronate once per week for 24 months

Placebo

Aurélie Fontana, M.D

Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.

This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer

Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer

Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.

Hospices Civils de Lyon

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

Etidronic Acid

One tablet by mouth every week as directed

Placebo risedronate oral tablet

Pamela Taxel, MD

Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.

A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone were measured at baseline and at 6 months.

Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer

The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men

BMD was measured by dual-energy X-ray absorptiometry (Lunar DXA-IQ, Madison, WI, USA). The BMD of the femoral neck, total hip, and lumbar spine (L1-L4) was measured. Underlying data are no longer available; reported means have been estimated from the results publication.

Bone turnover markers including N-telopeptide (NTX), serum C-telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication.

Proctor and Gamble/Aventis

UConn Health

Principal Investigator

Calcium and Vitamin D

Particiapnts given 35 mg by mouth every week

Risedronate Plus Calcium and Vit D

Age, Categorical

Small number but otherwise no limitations.

Pamela Taxel MD

Percent change in femoral neck BMD from baseline

Percent change in total hip BMD from baseline

Percent change in lumbar spine BMD from baseline

Between group difference of percent change for the femoral neck BMD

Between group difference of percent change for total hip BMD

Femoral Neck

Total Hip

Lumbar Spine

Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily

Calcium and Vitamin D Daily (Placebo Group)

Percent Change in Bone Mineral Density

Between group difference of percent change for NTX

Between group difference of percent change for CTX

P1NP

Percent Change of Bone Turnover Markers

Pts receiving LHRH-agonists for prostate cancer received active risedronate.

They also received daily calcium + Vit D

Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily

Pts received placebo risedronate + calcium and Vit D.

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Alendronate

Raloxifene Hydrochloride

Ibandronic Acid

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT	NCT03861091	Lung Neoplasm	risedronate Matching placeb...	18 Years -	Wake Forest University Health Sciences
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer	NCT00859703	Breast Cancer Menopause Osteopenia	Risedronate Placebo	18 Years -	Hospices Civils de Lyon
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer	NCT00859027	Prostate Cancer	risedronate Placebo risedro...	55 Years - 85 Years	UConn Health
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
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer	NCT00859703	Breast Cancer Menopause Osteopenia	Risedronate Placebo	18 Years -	Hospices Civils de Lyon
Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer	NCT00426777	Prostate Cancer	risedronate risedronate Control	18 Years -	CMX Research
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
Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy	NCT00216060	Metastatic Pros...	Risedronate Placebo	18 Years -	Hoosier Cancer Research Network
Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy	NCT00485953	Bone Loss Osteoporosis Breast Cancer	risedronate	55 Years -	University of Pittsburgh
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer	NCT00859027	Prostate Cancer	risedronate Placebo risedro...	55 Years - 85 Years	UConn Health
Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT	NCT03861091	Lung Neoplasm	risedronate Matching placeb...	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for risedronate

Every month we try and update this database with for risedronate 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 risedronate

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