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Bone Health in Gynecologic Cancers-does FOSAVANCE Help? (FOSAVANCE)

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ClinicalTrials.gov Identifier: NCT00593580
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : June 29, 2011
Sponsor:
Information provided by:
British Columbia Cancer Agency

Brief Summary:

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 or disease Intervention/treatment Phase
Ovarian Cancer Drug: placebo Drug: alendronate/cholecalciferol Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies.
Study Start Date : February 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration
Drug: alendronate/cholecalciferol
FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration
Other Name: FOSAVANCE
Placebo Comparator: 2 Drug: placebo
placebo



Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593580


Locations
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Jessica McALpine, MD UBC/BCCA

Responsible Party: Jessica McAlpine, MD, UBC and BCCA
ClinicalTrials.gov Identifier: NCT00593580     History of Changes
Other Study ID Numbers: H06-03974
9427-UO146-93C
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011

Keywords provided by British Columbia Cancer Agency:
Ovarian cancer
bone mineral density
bisphosphonates
chemotherapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cholecalciferol
Alendronate
Diphosphonates
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents