MedTrace Logo

Bone Health in Gynecologic Cancers-does FOSAVANCE Help?

NCT00593580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-06-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

placebo

placebo

DRUG

alendronate/cholecalciferol

FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Jessica McALpine, MD · UBC/BCCA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593580 on ClinicalTrials.gov