NCT00009945 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Atula S, Powles T, Paterson A, McCloskey E, Nevalainen J, Kanis J
Extended safety profile of oral clodronate after long-term use in primary breast cancer patients. Drug Saf. 2003;26(9):661-71.
Atula ST, Paterson AHG, Powles TJ, et al
: Safety profile of oral clodronate during long-term use in primary breast cancer patients. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-100, 25, 2003.
Powles T, Paterson S, Kanis JA, McCloskey E, Ashley S, Tidy A, Rosenqvist K, Smith I, Ottestad L, Legault S, Pajunen M, Nevantaus A, Männistö E, Suovuori A, Atula S, Nevalainen J, Pylkkänen L
Randomized, placebo-controlled trial of clodronate in patients
Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL
Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg. 2004 May;62(5):527-34.

A Clinical Trial Comparing Adjuvant Clodronate Therapy vs Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Hormonal Therapy or No Therapy

Details for clinical trial NCT00009945

Clinical trial NCT00009945 - References