Trial Outcomes & Findings for Denosumab in Primary Hyperparathyroidism (NCT NCT01558115)

NCT ID: NCT01558115

Last Updated: 2022-11-02

Results Overview

Percent change from baseline in BMD at the lumbar spine, as measured by Dual-emission X-ray absorptiometry (DXA) scan at 12 months

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2022-11-02

Participant Flow

The data were not collected per arm. This study was closed with the Institutional Review Board (IRB) in 2014 and additional analyses cannot be completed.

Participant milestones

Measure	Denosumab - Group #1 or Placebo - Group #2 Denosumab - Group #1 Receive active drug for year 1 and year 2 of the study Placebo - Group #2 Receive placebo for year 1 and active drug for year 2 of the study Investigator is blinded
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Denosumab - Group #1 or Placebo - Group #2 Denosumab - Group #1 Receive active drug for year 1 and year 2 of the study Placebo - Group #2 Receive placebo for year 1 and active drug for year 2 of the study Investigator is blinded
Overall Study Withdrawal by Subject	3
Overall Study Study closed due to poor enrollment	4

Baseline Characteristics

Denosumab in Primary Hyperparathyroidism

Baseline characteristics by cohort

Measure	Denosumab - Group #1 or Placebo - Group #2 n=8 Participants Denosumab - Group #1 Receive active drug for year 1 and year 2 of the study Placebo - Group #2 Receive placebo for year 1 and active drug for year 2 of the study Investigator is blinded
Age, Customized 18-65 years	3 Participants n=5 Participants
Age, Customized > 65 years	5 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Data was not collected and analyzed due to study closing prematurely because of poor enrollment.

Percent change from baseline in BMD at the lumbar spine, as measured by Dual-emission X-ray absorptiometry (DXA) scan at 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Data was not collected and analyzed due to study closing prematurely because of poor enrollment.

Percent change from baseline in BMD at the distal 1/3 radius, as measured by Dual-emission X-ray absorptiometry (DXA) scan at 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Data was not collected and analyzed due to study closing prematurely because of poor enrollment.

Percent change from baseline in BMD at the hip, as measured by Dual-emission X-ray absorptiometry (DXA) scan at 12 months

Outcome measures

Outcome data not reported

Adverse Events

Denosumab - Group #1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo - Group #2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John P. Bilezikian, MD

Columbia University

Phone: 212-305-6257

Email: jpb2@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place