Hypoparathyroidism Post-surgical
Conditions
Keywords
Hypoparathyroidism
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.
Interventions
DRUGTeriparatide
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Analysis | Approximately 90 days after surgery | Arms were compared for total number of adverse events, including severe and serious adverse events. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Teriparatide | Control | Total |
|---|---|---|---|
| Age, Continuous | 41 years | 40 years | 41 years |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
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).
Time frame: Approximately 7 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Hospital Length of Stay | 1.1 days | Standard Deviation 0.4 |
| Control | Hospital Length of Stay | 2.4 days | Standard Deviation 1.1 |
Comparison: Matched pairsp-value: 0.01Matched pairs t test
Secondary
Safety Analysis
Arms were compared for total number of adverse events, including severe and serious adverse events.
Time frame: Approximately 90 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Teriparatide | Safety Analysis | 0 events |
| Control | Safety Analysis | 0 events |