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Sponsored by: |
British Columbia Cancer Agency |
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Information provided by: | British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT00593580 |
Women who undergo bilateral oophorectomy and receive chemotherapy are at risk of increased bone loss. At present, despite having a risk factor profile that fits the indications for assessment and treatment there are no routine interventions in this patient population i.e., the standard treatment is no treatment. We hope to identify whether or not an intervention may be favorable in these women and change the standard of care in this vulnerable population.
Hypothesis:
Weekly therapy with alendronate + vitamin D (FOSAVANCE) will improve bone health as measured by DEXA scans in women with gynecologic malignancies undergoing chemotherapy as compared with patients receiving placebo.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: placebo Drug: alendronate/cholecalciferol |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies. |
Estimated Enrollment: | 60 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration
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Drug: alendronate/cholecalciferol
FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration
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2: Placebo Comparator |
Drug: placebo
placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jessica N McALpine, MD | 604 875 5608 | jessica.mcalpine@vch.ca |
Canada, British Columbia | |
BC Cancer Agency | Recruiting |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Contact: Jessica McALpine 604 875 5608 jessica.mcalpine@vch.ca | |
Principal Investigator: Jessica McAlpine, MD |
Principal Investigator: | Jessica McALpine, MD | UBC/BCCA |
Responsible Party: | UBC and BCCA ( Jessica McAlpine, MD ) |
Study ID Numbers: | H06-03974, 9427-UO146-93C |
Study First Received: | January 4, 2008 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00593580 History of Changes |
Health Authority: | Canada: Health Canada |
Ovarian cancer bone mineral density bisphosphonates chemotherapy |
Cholecalciferol Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Bone Density Conservation Agents Trace Elements Urogenital Neoplasms Ovarian Diseases |
Genital Diseases, Female Diphosphonates Alendronate Vitamins Ovarian Cancer Micronutrients Endocrinopathy Endocrine Gland Neoplasms |
Cholecalciferol Ovarian Neoplasms Gonadal Disorders Growth Substances Physiological Effects of Drugs Genital Neoplasms, Female Endocrine System Diseases Bone Density Conservation Agents Urogenital Neoplasms Ovarian Diseases |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Diphosphonates Alendronate Vitamins Micronutrients Endocrine Gland Neoplasms |