Bone Health in Gynecologic Cancers-does FOSAVANCE Help?

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: British Columbia Cancer Agency
• Treatments: Alendronate; Cholecalciferol; Diphosphonates

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