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

Breast Cancer Clinical Trial

Official title:

Bone Retention of Bisphosphonate (Zometa) in Patients With Multiple Myeloma or Breast Cancer With Metastases to Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760370
• Other study ID #: 2007-003777-13
• Secondary ID: 2007-003777-13
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2008
• Last updated: December 6, 2011
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

The clinical benefit from treatment with bisphosphonates has been documented in a large number of clinical studies, and bisphosphonates are now widely used for treatment of pain and prevention of bone fractures or vertebral collapse for example in patients with cancer metastasis to bone or multiple myeloma.

Repeated intravenous administration of the more potent bisphosphonates (pamidronate and zoledronic acid) are often used for treatment of osteolytic disease caused by disseminated cancer or multiple myeloma, while the less potent oral bisphosphonates are often prescribed for treatment of benign osteoporosis. The recommended dose and time schedule for treatment with the more potent bisphosphonates is based on concerns of avoiding toxicity and at the same time obtaining maximal clinical benefit. Clinical studies in multiple myeloma and bone metastasis show significant activity of pamidronate (90 mg by iv infusion during 2-4 hours) or zoledronic acid (4 mg iv during 15 min) repeated every 4 weeks after a treatment period of 9 months and beyond, but the optimal duration of treatment is not known. This is a particular important issue since the use of potent bisphosphonates have been brought in connection with osteonecrosis.

In the present study we will compare the retention of Zometa with the effect on bone markers in patients with multiple myeloma or breast cancer with metastases to bone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Zoledronic Acid
4 mg intravenous (iv), one treatment

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense
Denmark	Vejle Hospital	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
Vejle Hospital	Novartis, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & 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. Epub 2005 May 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Zometa retained in body		48 hrs	No
Secondary	Changes in bone markers		14 days	No