Acromegaly Combination Treatment Study

Summary

In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.

Timeline

Start

2012-03-29

Primary completion

2022-05-20

Completion

2022-05-20

Outcome

Outcome not reported

Stopped (Enrollment): “Review of the 12-month data showed patients who deviated from protocol with full IRB monitoring and reporting could not be optimally analyzed. Reopening the study for new enrollment is not feasible and the study was terminated with IRB approval.”

Publications

• Results Bonert V, Mirocha J, Carmichael J, Yuen KCJ, Araki T, Melmed S. Cost-Effectiveness and Efficacy of a Novel Combination Regimen in Acromegaly: A Prospective, Randomized Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9):dgaa444. doi: 10.1210/clinem/dgaa444.

Drugs

Indications