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

This study has been terminated.

( Terminated due to slow accrual. )

Study NCT00623974 Information provided by M.D. Anderson Cancer Center

First Received on February 14, 2008. Last Updated on June 27, 2011 History of Changes

Results First Received: August 13, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypocalcemia
Interventions:	Drug: Teriparatide (Forteo) Drug: Calcium Drug: Calcitriol

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: May 2, 2008 to April 13, 2009. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Calcium + Calcitriol	Teriparatide 20 Mcg	Teriparatide 40 Mcg	Teriparatide 60 Mcg
STARTED	0	0	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Reporting Groups

	Description
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

Baseline Measures

	Calcium + Calcitriol	Teriparatide 20 Mcg	Teriparatide 40 Mcg	Teriparatide 60 Mcg	Total
Number of Participants [units: participants]	0	0	0	0	0
Age [units: years] Median ( Full Range )
Gender [units: participants]
Female
Male
Region of Enrollment [units: participants]
United States					unknown

Outcome Measures

1. Primary:

Number of Patients With Success [ Time Frame: 2 - 7 days post-treatment ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Mimi Hu, MD / Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org

No publications provided

Responsible Party:	Mimi Hu, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00623974 History of Changes
Other Study ID Numbers:	2006-0562
Study First Received:	February 14, 2008
Results First Received:	August 13, 2010
Last Updated:	June 27, 2011
Health Authority:	United States: Food and Drug Administration