NCT00001728 - 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)

Czerwiec FS, Collins M, Feuillan P, Shenker A
Further study of the therapy for fibrous dysplasia is necessary. J Bone Miner Res. 1997 Dec;12(12):2128-30.
Liens D, Delmas PD, Meunier PJ
Long-term effects of intravenous pamidronate in fibrous dysplasia of bone. Lancet. 1994 Apr 16;343(8903):953-4.
Mastorakos G, Mitsiades NS, Doufas AG, Koutras DA
Hyperthyroidism in McCune-Albright syndrome with a review of thyroid abnormalities sixty years after the first report. Thyroid. 1997 Jun;7(3):433-9.

A Randomized, Placebo-Controlled Trial of Alendronate in the Treatment of Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome

Clinical trial NCT00001728 - References