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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00593580 |
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Date of registration:
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04/01/2008 |
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Primary sponsor: |
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Public title:
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Bone Health in Gynecologic Cancers-does FOSAVANCE Help?
FOSAVANCE |
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Scientific title:
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The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies. |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00593580 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jessica McALpine, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UBC/BCCA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Postmenopausal (surgical extirpation of ovaries)
2. Primary ovarian or endometrial cancer
3. Planned to receive multiagent chemotherapeutic regimen for 6 cycles
4. Signed informed consent
5. BMD T-score between -2.5 and 0 at any site
Exclusion Criteria:
1. Renal insufficiency with CrCl < 35mL/min
2. BMD T-score < -2.5 at any site
3. Medication, excessive alcohol intake, or GI disease inhibiting GI absorption
4. Metabolic bone disease, bony metastases, poorly controlled thyroid or parathyroid
conditions, Paget's disease, or on hormonal therapy/other treatments for OP
5. Abnormalities of the esophagus which delay esophageal emptying i.e., achalasia
6. Inability to stand or sit upright for at least 30 minutes
7. Hypersensitivity to any component of the drug product
8. Requiring/planned external beam radiation during study period
9. Baseline serum 25(OH) vitamin D levels of < 9ng/mL
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Intervention(s)
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Drug: alendronate/cholecalciferol
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Drug: placebo
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Primary Outcome(s)
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Bone mineral density
[Time Frame: 12 months]
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Secondary ID(s)
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9427-UO146-93C
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H06-03974
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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