Bone Health in Gynecologic Cancers-Does FOSAVANCE Help? - Full Text View

Sponsored by:	British Columbia Cancer Agency
Information provided by:	British Columbia Cancer Agency
ClinicalTrials.gov Identifier:	NCT00593580

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 II

MedlinePlus related topics: Cancer Minerals Ovarian Cancer

Drug Information available for: Alendronate Alendronate sodium Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies.

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
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Placebo Comparator	Drug: placebo placebo

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Postmenopausal (surgical extirpation of ovaries)
Primary ovarian or endometrial cancer
Planned to receive multiagent chemotherapeutic regimen for 6 cycles
Signed informed consent
BMD T-score between -2.5 and 0 at any site

Exclusion Criteria:

Renal insufficiency with CrCl < 35mL/min
BMD T-score < -2.5 at any site
Medication, excessive alcohol intake, or GI disease inhibiting GI absorption
Metabolic bone disease, bony metastases, poorly controlled thyroid or parathyroid conditions, Paget's disease, or on hormonal therapy/other treatments for OP
Abnormalities of the esophagus which delay esophageal emptying i.e., achalasia
Inability to stand or sit upright for at least 30 minutes
Hypersensitivity to any component of the drug product
Requiring/planned external beam radiation during study period
Baseline serum 25(OH) vitamin D levels of < 9ng/mL

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593580

Contacts

Contact: Jessica N McALpine, MD

604 875 5608

jessica.mcalpine@vch.ca

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

Responsible Party:	UBC and BCCA ( Jessica McAlpine, MD )
Study ID Numbers:	H06-03974, 9427-UO146-93C
Study First Received:	January 4, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00593580
Health Authority:	Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:

Ovarian cancer
bone mineral density
bisphosphonates
chemotherapy

Study placed in the following topic categories:

Ovarian cancer
Cholecalciferol
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms

Ovarian Diseases
Genital Diseases, Female
Diphosphonates
Alendronate
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009