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

This study has been completed.
Information provided by:
British Columbia Cancer Agency Identifier:
First received: January 4, 2008
Last updated: June 27, 2011
Last verified: June 2011

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.


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
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.

Resource links provided by NLM:

Further study details as provided by British Columbia Cancer Agency:

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

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
Placebo Comparator: 2 Drug: placebo

  Show Detailed Description


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00593580

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

Responsible Party: Jessica McAlpine, MD, UBC and BCCA Identifier: NCT00593580     History of Changes
Other Study ID Numbers: H06-03974
Study First Received: January 4, 2008
Last Updated: June 27, 2011

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on August 18, 2017