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A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
Primary Objective: -To identify the optimal dose of a seven-day course of twice-daily teriparatide as compared to standard therapy for hypocalcemia in patients after total thyroidectomy and/or extensive neck dissections (pharyngectomy, laryngectomy,unilateral, bilateral / central neck, mediastinal lymph node neck dissections), with which serum calcium will be raised to corrected serum calcium levels of 8-10.5mg/dL and maintained within this range until the end of the treatment course.
Details
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 7 |
| Start date | 2008-05 |
| Completion | 2010-06 |
Conditions
- Hypocalcemia
Interventions
- Teriparatide (Forteo)
- Calcium
- Calcitriol
Primary outcomes
- Number of Patients With Success — 2 - 7 days post-treatment
A patient "success" is defined as a normal calcium level (Ca\>=8 and Ca\<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation.
Countries
United States