Osteoporosis Clinical Trial
Official title:
A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Surgery That Results in Removal of Both Ovaries
NCT number | NCT00305695 |
Other study ID # | GOG-0215 |
Secondary ID | NCI-2009-00589NC |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 28, 2005 |
Verified date | March 2020 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries.
Status | Completed |
Enrollment | 160 |
Est. completion date | |
Est. primary completion date | December 22, 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients who have elected to undergo, or who have undergone (within 8 weeks) a surgical procedure that results (at minimum) in the absence of both ovaries - Patients enrolled in the screening arm of GOG-0199 who decide to undergo surgery are potentially eligible for GOG-0215 - Baseline bone mass density (BMD) T-Score ? -1.5 (no more than 1.5 standard deviation below the mean value for young adults) on both the total lumbar spine (L1-L4 region, not individual bones) and bilateral hip - Patients who had/have at least 1 intact ovary at the time of surgery are eligible - No prior distant metastatic malignant disease within the past 5 years - Patients treated for stage M1 (any T, any N) diagnosis in the past 5 years are ineligible - Patients who achieved a complete response after treatment for rM0 (any T, any N) within the past 5 years are eligible - Premenopausal* - Last menstrual cycle occurred < 12 months prior to study enrollment - GOG performance status 0-2 - Creatinine clearance > 60 mL/min - No clinical or radiological evidence of existing fracture of the lumbar spine or bilateral hip - No history of hip of spine fracture with low-intensity trauma or not associated with trauma - No uncontrolled seizure disorder associated with falls - No diseases that influence bone metabolism, including any of the following: - Paget?s disease - Osteogenesis imperfecta - Uncontrolled thyroid or parathyroid dysfunction within 12 months prior to study entry - No other nonmalignant systemic disease, including any of the following: - Uncontrolled infection - Uncontrolled type 2 diabetes mellitus - Cardiovascular, renal, hepatic, or lung disease that would prevent prolonged follow-up - History of thrombosis or thromboembolism allowed - No known HIV positivity - No known hypersensitivity to zoledronate or other bisphosphonates - No psychiatric, psychological, or other conditions that prevent fully informed consent - No other active malignancy except nonmelanoma skin cancer - No history of any medical condition that places the patient at risk for donating blood for research purposes (e.g., chronic infectious diseases, sever anemia, or hemophilia) - Not pregnant - Negative pregnancy test - No current active dental problems, including any of the following: - Infection of the teeth or jawbone (maxilla or mandible) - Dental or fixture trauma - Current or prior diagnosis of osteonecrosis of the jaw - Exposed bone in the mouth - Slow healing after dental procedures - No recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction or implants) - No prior treatment for osteoporosis - No adjuvant radiotherapy within the past 31 days - No chemotherapy within the past 30 days - No prior surgery to the hip or spine - No prior systemic sodium fluoride for > 3 months during the past 2 years - No more than 30 days use in the past 12 months and no concurrent tamoxifen, raloxifene, or any other selective estrogen-receptor modulator (SERM) - More than 12 months since prior and no concurrent endocrine therapy - Insulin and/or oral antidiabetic medications allowed - Thyroid hormone replacement allowed - More than 12 months since prior and no concurrent estrogen or hormone replacement therapy (estrogen plus progesterone or estrogen alone) - Prior or concurrent oral contraceptives allowed - Systemic (oral) hormone replacement therapy following surgery not allowed - Vaginal (non-systemic) estrogen allowed - More than 12 months since prior and no concurrent oral or IV bisphosphonate - More than 12 months since prior and no concurrent anabolic steroids or growth hormone - More than 12 months since prior and no concurrent systemic corticosteroids - Concurrent short term corticosteroid therapy (to prevent/treat chemotherapy-induced nausea/vomiting) allowed - More than 6 months since prior and no concurrent Tibolone - More than 2 weeks since prior and no concurrent drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) - No concurrent chemotherapy or radiotherapy - No concurrent aromatase inhibitors - Concurrent enrollment on protocol GOG-0199 allowed |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | The Don and Sybil Harrington Cancer Center | Amarillo | Texas |
United States | Colorado Gynecologic Oncology Group | Aurora | Colorado |
United States | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California |
United States | Cone Health Cancer Center at Alamance Regional | Burlington | North Carolina |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | Chattanooga's Program in Women's Oncology | Chattanooga | Tennessee |
United States | University of Illinois | Chicago | Illinois |
United States | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio |
United States | University of Cincinnati/Barrett Cancer Center | Cincinnati | Ohio |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Rose Medical Center | Denver | Colorado |
United States | SCL Health Saint Joseph Hospital | Denver | Colorado |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | Jupiter Medical Center | Jupiter | Florida |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Truman Medical Center | Kansas City | Missouri |
United States | Northwell Health/Center for Advanced Medicine | Lake Success | New York |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky |
United States | McKee Medical Center | Loveland | Colorado |
United States | North Shore University Hospital | Manhasset | New York |
United States | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | Virtua Memorial | Mount Holly | New Jersey |
United States | Meharry Medical College | Nashville | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Yale University | New Haven | Connecticut |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York |
United States | Mount Sinai Hospital | New York | New York |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | UF Cancer Center at Orlando Health | Orlando | Florida |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
United States | FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Women and Infants Hospital | Providence | Rhode Island |
United States | Center of Hope at Renown Medical Center | Reno | Nevada |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Carilion Clinic Gynecological Oncology | Roanoke | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Saint Louis-Cape Girardeau CCOP | Saint Louis | Missouri |
United States | University of California San Diego | San Diego | California |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Banner University Medical Center - Tucson | Tucson | Arizona |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma |
United States | Carle Cancer Center | Urbana | Illinois |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Northwestern Medicine Central DuPage Hospital | Winfield | Illinois |
United States | Main Line Health NCORP | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months | To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA). | 9 Months | |
Primary | Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months | To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 18 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA). | 18 months | |
Primary | Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip | To compare the effect of zoledronic acid on the change in BMD of the right hip following treatment, evaluated by measuring the change from baseline to 18 months | 18 months | |
Primary | Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip | To compare the effect of zoledronic acid on the change in BMD of the left hip following treatment, evaluated by measuring the change from baseline to 18 months | 18 months |
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