Teriparatide for Postsurgical Hypoparathyroidism

NCT01171690 | Terminated Phase 2 Results DMC

• 1 other identifier: 10-000901
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoparathyroidism Post-surgical

Keywords

Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay

  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).

  Approximately 7 days after surgery

Secondary Outcomes (1)

• Safety Analysis

  Approximately 90 days after surgery

Study Arms (1)

Teriparatide

EXPERIMENTAL

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.

Drug: Teriparatide

Interventions

Teriparatide DRUG

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.

Also known as: Forteo

Teriparatide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Renal failure
• Any prior parathyroid pathology
• Pre-existing hypercalcemia
• Metabolic bone diseases other than osteoporosis
• Pagets disease
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypoparathyroidism

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Marius Stan, MD
• Organization: Mayo Clinic

stan.marius@mayo.edu

507-284-2463

Study Officials

• Marius Stan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 22, 2014
• Results First Posted: December 22, 2014

Record last verified: 2014-12

Locations

US (1)