Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Teriparatide for Postsurgical Hypoparathyroidism

NCTNCT01171690Other id10-000901

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Funding problems

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 5 participants (actual)
Sponsor: Mayo Clinic · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2010
Primary completion: Dec 2013
Completion: Dec 2013
First posted: 28 Jul 2010 (estimated)
Last update posted: 22 Dec 2014 (estimated)
Conditions: Hypoparathyroidism Post-surgical

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20102011201220132014

Ph 2
Teriparatide for Postsurgical Hypoparathyroidism
NCT01171690
Nov 2010 to Dec 2013
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism.

Interventions

TeriparatideDrug

Arms1

Experimental
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Hospital Length of Stay
Time frame · Approximately 7 days after surgery
Registry description
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).

Secondary outcomes(1)

Safety Analysis
Time frame · Approximately 90 days after surgery
Registry description
Arms were compared for total number of adverse events, including severe and serious adverse events.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Approximately 7 days after surgery

Hospital Length of Stay

Group	Value (days)	Spread
Teriparatide	1.1	0.4
Control	2.4	1.1

Secondary and other outcome results(1)

Secondary outcomeNumber· Approximately 90 days after surgery

Safety Analysis

Group	Value (events)
Teriparatide	0
Control	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
TeriparatideThe 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. There were no adverse events related to the use of teriparatide.	–	0 / 5	0 / 5
ControlThese 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.	–	0 / 5	0 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria: * Patients post bilateral thyroid bed surgery (cancer, Graves disease, multinodular goiter) * Symptomatic hypocalcemia * Total calcium \< 8 mg/dL persisting after 24 hours of therapy with calcitriol (minimum 0.25 mcg twice a day) and calcium supplementation (minimum 1.5 grams of elemental calcium per day) * Parathyroid hormone (PTH) level below low end of normal range Exclusion criteria (all subjects): * Renal failure * Any prior parathyroid pathology * Pre-existing hypercalcemia * Metabolic bone diseases other than osteoporosis * Pagets disease Exclusion criteria (active treatment subjects only): * Ongoing therapy with Forteo for osteoporosis * Active non-thyroidal malignancy or suspicion of residual thyroid malignancy * History of skeletal malignancies, primary or metastatic * Pregnancy * Active or recent urolithiasis * Digitalis therapy * Patients at increased baseline risk for osteosarcoma, i.e., family history of osteosarcoma or prior radiation therapy involving the skeleton * Pediatric populations * Unexplained elevations of alkaline phosphatase

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