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

Phase 2
Not Enrolling
Multiple Myeloma, Breast Cancer

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Trial Information

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

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.

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)

Type of Study:


Study Design:

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

Outcome Measure:

Amount of Zometa retained in body

Outcome Time Frame:

48 hrs

Safety Issue:


Principal Investigator

Torben Plesner, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vejle Hospital


Denmark: Danish Medicines Agency

Study ID:




Start Date:

December 2008

Completion Date:

December 2011

Related Keywords:

  • Multiple Myeloma
  • Breast Cancer
  • bone marker
  • bisphosphonate
  • Zometa
  • retention
  • breast cancer
  • multiple myeloma
  • CTX
  • bone specific ALP
  • Breast Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Urinary Retention