Denosumab in Primary Hyperparathyroidism

PHASE4TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Primary Hyperparathyroidism
Interventions
DRUG

Denosumab

"The dose of denosumab is 60 mg every 6 months by subcutaneous injection.~The 52 subjects will be randomly allocated (2:1) into treatment and placebo arms with the placebo group receiving a subcutaneous injection of vehicle in year 1. In year 2, those who were allocated to the study drug in year 1 will continue in year 2. Those who were allocated to placebo in year 1 will be crossed over to study drug in year 2.~Group # 1: Receive active drug for year 1 and year 2 of the study~Group #2: Receive placebo for year 1 and active drug for year 2 of the study"

OTHER

Placebo

"The dose of denosumab is 60 mg every 6 months by subcutaneous injection. The placebo group will receive vehicle injections at the same time interval.~The 52 subjects will be randomly allocated (2:1) into treatment and placebo arms with the placebo group receiving a subcutaneous injection of vehicle in year 1. In year 2, those who were allocated to the study drug in year 1 will continue in year 2. Those who were allocated to placebo in year 1 will be crossed over to study drug in year 2.~Group # 1: Receive active drug for year 1 and year 2 of the study~Group #2: Receive placebo for year 1 and active drug for year 2 of the study"

Trial Locations (1)

10032

Columbia University Medical Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

Amgen

INDUSTRY

lead

Columbia University

OTHER

NCT01558115 - Denosumab in Primary Hyperparathyroidism | Biotech Hunter | Biotech Hunter