Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer

NCT00760370 | Completed Phase 2 DMC

• 1 other identifier: 2007-003777-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators major aim is to determine whether there is a difference in the retention of zoledronic acid in multiple myeloma patients, compared to patients with breast cancer metastasis to bone. In addition the investigators wish to analyze if the retention of zoledronic acid is correlated to the extent of bone resorption/formation, and if there is a tendency to changes in retention with sequential treatment.

Conditions

Multiple Myeloma; Breast Cancer

Keywords

bone marker; bisphosphonate; Zometa; retention; breast cancer; multiple myeloma; CTX; bone specific ALP

Outcome Measures

Primary Outcomes (1)

• Amount of Zometa retained in body

  48 hrs

Secondary Outcomes (1)

• Changes in bone markers

  14 days

Interventions

Zoledronic Acid DRUG

4 mg intravenous (iv), one treatment

Also known as: Zometa

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with breast cancer and metastases to bone.
• Patients diagnosed with multiple myeloma.
• Patients who are scheduled to receive Zometa.
• Post-menopausal women (at least 10 months since last period).
• Newly diagnosed patients must have clear signs of osteolysis.

You may not qualify if:

• Anti-estrogen treatment.
• Patients given chemotherapy during or less than 7 days before study begin.
• Patients receiving glucocorticoids less than 5 days prior to study begin or during the study period (14 days)

Sponsors & Collaborators

• Vejle Hospital: lead
• Odense University Hospital: collaborator
• Novartis: collaborator

Study Sites (2)

Odense University Hospital

Odense, 5000, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (1)

• Cremers SC, Papapoulos SE, Gelderblom H, Seynaeve C, den Hartigh J, Vermeij P, van der Rijt CC, van Zuylen L. Skeletal retention of bisphosphonate (pamidronate) and its relation to the rate of bone resorption in patients with breast cancer and bone metastases. J Bone Miner Res. 2005 Sep;20(9):1543-7. doi: 10.1359/JBMR.050522. Epub 2005 May 31.

  PMID: 16059626 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Torben Plesner, MD, PhD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

DK (2)