Clinical trial NCT01171690: Teriparatide for Postsurgical Hypoparathyroidism
Official title: Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypoparathyroidism Post-surgical
Keywords: Hypoparathyroidism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Transient hypoparathyroidism with hypocalcemia occurs in up to 20 % of patients after surgery for thyroid cancer, multinodular goiter or Graves' disease and is severe in around 3 to 18% of cases. Severe hypocalcemia significantly lengthens their hospital stay. This study will evaluate the effects of teriparatide (synthetic parathyroid hormone, brand name Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone.

This was a feasibility open-label, single-arm trial with historical matched controls with a planned enrollment of 15 patients with severe, symptomatic hypocalcemia that would be treated with teriparatide for a maximum duration of 3 weeks and compared the active subjects with 30 gender and age matched controls.

Therapy for hypocalcemia continued in accordance with current practice. The decision for discharge, as far as calcium is concerned, was to be reached when calcium level was \> 7.5 mg/dL and increased x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for IV calcium in the last 24 hours. Subjects were followed by phone and with blood tests 2 days after discharge and 9, 17 and 25 days after initiation of teriparatide. They were off teriparatide for 24 hours prior to testing on days 9, 17 and 25.

If hypocalcemia recurred after 2nd week, teriparatide was continued for a 3rd week and then discontinued. If hypocalcemia recurred again current standard therapy for hypoparathyroidism was continued off teriparatide.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: Approximately 7 days after surgery
Secondary outcomes:
measure: Safety Analysis
timeFrame: Approximately 90 days after surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marius Stan, MD
role: PRINCIPAL_INVESTIGATOR
References: