Bone Health in Gynecologic Cancers-does FOSAVANCE Help?

NCT00593580 | Completed Phase 2 DMC

• 2 other identifiers: H06-039749427-UO146-93C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Ovarian Cancer

Keywords

Ovarian cancer; bone mineral density; bisphosphonates; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Bone mineral density

  12 months

Study Arms (2)

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

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

placebo

2

alendronate/cholecalciferol DRUG

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

Also known as: FOSAVANCE

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Alendronate; Cholecalciferol

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jessica McALpine, MD

  UBC/BCCA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 29, 2011

Record last verified: 2011-06

Locations

CA (1)