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Trial Outcomes & Findings for Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia (NCT NCT00623974)

NCT ID: NCT00623974

Last Updated: 2012-12-06

Results Overview

A patient "success" is defined as a normal calcium level (Ca\>=8 and Ca\<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

2 - 7 days post-treatment

Results posted on

2012-12-06

Participant Flow

Recruitment Period: May 2, 2008 to April 13, 2009. All recruitment done at UT MD Anderson Cancer Center.

A total of 7 patients were consented and screened. None of the patients met study entry criteria and thus were not randomized to treatment. Due to slow accrual, the study was closed.

Participant milestones

Participant milestones
Measure
Calcium + Calcitriol
1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Teriparatide 20 Mcg
Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Teriparatide 40 Mcg
Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Teriparatide 60 Mcg
Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Overall Study
STARTED
0
0
0
0
Overall Study
COMPLETED
0
0
0
0
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 - 7 days post-treatment

Population: Terminated due low accrual, none of 7 participants met eligibility criteria therefore not treated nor randomized to study arms.

A patient "success" is defined as a normal calcium level (Ca\>=8 and Ca\<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation.

Outcome measures

Outcome data not reported

Adverse Events

Calcium + Calcitriol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Teriparatide 20 Mcg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Teriparatide 40 Mcg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Teriparatide 60 Mcg

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

Mimi Hu, MD / Professor

UT MD Anderson Cancer Center

Results disclosure agreements

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