Trial Outcomes & Findings for Teriparatide for Postsurgical Hypoparathyroidism (NCT NCT01171690)

Results Overview

Hospital length of stay from initiation of therapy with calcium and calcitriol to "ready to discharge" from a calcium perspective (calcium level \> 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for intravenous (IV) calcium in last 24 hours).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Approximately 7 days after surgery

Results posted on

2014-12-22

Participant Flow

Patients recruited between 1/1/2010 and 1/12/2013; all patients were recruited at Mayo Hospitals in Rochester, Minnesota, USA. The controls were recruited from the pool of patients with similar degree of hypoparathyroidism postoperatively but previously to the initiation of the trial.

Participant milestones

Participant milestones
Measure	Teriparatide The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.	Control These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Teriparatide for Postsurgical Hypoparathyroidism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Teriparatide n=5 Participants The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.	Control n=5 Participants These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.	Total n=10 Participants Total of all reporting groups
Age, Continuous	41 years n=5 Participants	40 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 7 days after surgery

Hospital length of stay from initiation of therapy with calcium and calcitriol to "ready to discharge" from a calcium perspective (calcium level \> 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for intravenous (IV) calcium in last 24 hours).

Outcome measures

Outcome measures
Measure	Teriparatide n=5 Participants The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.	Control n=5 Participants These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
Hospital Length of Stay	1.1 days Standard Deviation 0.4	2.4 days Standard Deviation 1.1

SECONDARY outcome

Timeframe: Approximately 90 days after surgery

Arms were compared for total number of adverse events, including severe and serious adverse events.

Outcome measures

Outcome measures
Measure	Teriparatide n=5 Participants The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.	Control n=5 Participants These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
Safety Analysis	0 events	0 events

Adverse Events

Teriparatide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Marius Stan, MD

Mayo Clinic

Phone: 507-284-2463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place