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

NCT00054418 | Completed Phase 3

• 3 other identifiers: NCCTG-N02C1NCI-2012-02515CDR0000270449
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 199

Brief Summary

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.

Conditions

Breast Cancer; Osteoporosis

Keywords

osteoporosis; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

• Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry

  1 year post study entry

Secondary Outcomes (9)

• Average intra-patient change in femoral neck and total hip BMD from baseline to one year after study entry

  1 year post study entry

• Incidence of osteopenia in the risedronate vs placebo groups at one year after study entry

  1 year post study entry

• Incidence of osteoporosis in the risedronate vs placebo groups at one year after study entry

  1 year post study entry

• Incidence of a 5% difference in intra-patient BMD scores at baseline

  Baseline

• Serum and urine N-telopeptide and serum alkaline phosphatase at baseline and 6 months

  Up to 6 months

Study Arms (2)

calcium carbonate, vitamin D and risedronate

EXPERIMENTAL

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

Dietary Supplement: calcium carbonate; Dietary Supplement: vitamin D; Drug: risedronate sodium

calcium carbonate, vitamin D and placebo

PLACEBO COMPARATOR

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

Dietary Supplement: calcium carbonate; Dietary Supplement: vitamin D; Other: placebo

Interventions

calcium carbonate DIETARY_SUPPLEMENT

calcium 600 mg daily administered orally for one year

calcium carbonate, vitamin D and placebo; calcium carbonate, vitamin D and risedronate

vitamin D DIETARY_SUPPLEMENT

vitamin D 400 U daily administered orally for one year

calcium carbonate, vitamin D and placebo; calcium carbonate, vitamin D and risedronate

risedronate sodium DRUG

risedronate 35 mg weekly administered orally

calcium carbonate, vitamin D and risedronate

placebo OTHER

placebo tablet weekly administered orally for one year

calcium carbonate, vitamin D and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Required Characteristics 1. Premenopausal women * ≤ 6 months since last menstrual period * no prior bilateral oophorectomy * not on estrogen replacement therapy * if TAH is performed, with at least one intact ovary, or if \> 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry 2. Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB) 3. ≥ 18 years of age 4. ECOG performance status (PS) 0 or 1 2. Contraindications 1. Hypercalcemia (calcium level \> 1mg/dL above UNL ≤ 6 months 2. Hypocalcemia (calcium level \> 0.5 mg/dL below UNL ≤ 6 months 3. Inability to stand or sit upright for at least 30 minutes 4. Known swallowing disorder 5. Bone mineral density T score of ≤ - 2.0 at the hip or lumbar spine * a patient with a T score of - 2.1 is ineligible * a patient with a T score of - 1.9 is eligible 6. History of vertebral compression fracture * Exception: traumatic fracture of the coccyx would not exclude a patient from participation 7. Corticosteroids at doses \> 5 mg daily of prednison or equivalent for \> 2 weeks in the past 6 months 8. Previous treatment with bisphosphonates 9. Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism) 10. History of severe renal impairment or creatinine \> 2.0 mg/dL 11. Malabsorption syndrome 12. Estrogen replacement therapy 13. Oral contraceptive use 14. Prior bilateral oophorectomy 15. Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device \[IUD\], surgical sterilization, abstinence, etc.) * This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown 16. Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (199)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Aurora Presbyterian Hospital

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301-9019, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80502, United States

Location

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thorton, Colorado, 80229, United States

Location

Unknown Facility

Gainesville, Florida, 32605, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342-1611, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274-2600, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Trinity Medical Center - East

Moline, Illinois, 61265, United States

Location

Unknown Facility

Moline, Illinois, 61265, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Valley Cancer Center

Spring Valley, Illinois, 61362, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

McFarland Clinic, P. C.

Ames, Iowa, 50010, United States

Location

Unknown Facility

Bettendorf, Iowa, 52722, United States

Location

Saint Anthony Regional Hospital

Carroll, Iowa, 51401, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Alegent Health Mercy Hospital

Council Bluffs, Iowa, 51503, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

Alegent Health Community Memorial Hospital

Missouri Valley, Iowa, 51555-1199, United States

Location

Burgess Health Center

Onawa, Iowa, 51040, United States

Location

Ottumwa Regional Health Center Cancer Center

Ottumwa, Iowa, 52501, United States

Location

Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center

Sioux City, Iowa, 51101, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Cancer Center of Kansas, P.A. - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, P.A. - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, P.A. - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, P.A. - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, P.A. - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, P.A. - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, P.A. - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas, P.A. - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, P.A. - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A. - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, P.A. - Winfield

Winfield, Kansas, 67156, United States

Location

Ochsner Clinic of Baton Rouge

Baton Rouge, Louisiana, 708169990, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, 49431, United States

Location

Green Bay Oncology, Limited - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

Haematology-Oncology Associates of Ohio and Michigan, P.C.

Lambertville, Michigan, 48144, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital System

Monroe, Michigan, 48162, United States

Location

MeritCare Clinic - Bemidji

Bemidji, Minnesota, 56601, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller-Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Immanuel St. Joseph's Clinic

Mankato, Minnesota, 56002, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Hattiesburg Clinic, P.A.

Hattiesburg, Mississippi, 39401, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Deaconess Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Internal Medicine Associates of Bozeman

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Eastern Montana Cancer Center

Miles City, Montana, 59301, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Bryan LGH Medical Center West

Lincoln, Nebraska, 68502, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

St. Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

Midlands Cancer Center at Midlands Community Hospital

Papillion, Nebraska, 68046-4194, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Cancer Care Center at Medcenter One Hospital

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, P. C.

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center

Bismarck, North Dakota, 58502, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Medical Group

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, 58201, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Kenton Oncology, Incorporated

Kenton, Ohio, 43326, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Promedica Cancer Center at Flower Hospital

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical College of Ohio Cancer Institute

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

Toledo Surgical Specialists

Toledo, Ohio, 43623, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57105-1080, United States

Location

Medical X-Ray Center, P. C.

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (2)

• Hines SL, Mincey BA, Sloan JA, Thomas SP, Chottiner E, Loprinzi CL, Carlson MD, Atherton PJ, Salim M, Perez EA. Phase III randomized, placebo-controlled, double-blind trial of risedronate for the prevention of bone loss in premenopausal women undergoing chemotherapy for primary breast cancer. J Clin Oncol. 2009 Mar 1;27(7):1047-53. doi: 10.1200/JCO.2008.19.1783. Epub 2008 Dec 15.

  PMID: 19075260 RESULT

• Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

  PMID: 38979716 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Calcium Carbonate; Vitamin D; Risedronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephanie Hines, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: March 1, 2003
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2008
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (198); CA (1)