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Bone Health in Gynecologic Cancers-does FOSAVANCE Help?

This study has been completed.
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00593580
First received: January 4, 2008
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Ovarian Cancer
 Drug: placebo
Drug: alendronate/cholecalciferol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jessica McAlpine, MD, UBC and BCCA
ClinicalTrials.gov Identifier: NCT00593580     History of Changes
Other Study ID Numbers: H06-03974, 9427-UO146-93C
Study First Received: January 4, 2008
Last Updated: June 27, 2011
Health Authority: Canada: Health Canada

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
Diphosphonates
Alendronate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013