A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Patients With Success
研究概览
简要总结
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.
详细描述
Teriparatide is designed to act like a natural human hormone called parathyroid hormone, which can increase the blood levels of calcium. Calcium plus calcitriol is considered the standard treatment for low calcium in the blood.
After scheduled surgery, the level of calcium in the blood will be monitored according to the standard of care. Between 18 and 24 hours after the surgery, if calcium level drops below an acceptable level, or participants develop symptoms of low calcium, they will be randomly assigned (as in the toss of a coin) to 1 of 4 groups. One group (the "standard-of-care" group) will receive calcium plus calcitriol alone, for 7 days. The other groups (the "teriparatide" groups) will receive 1 of 3 different dose levels of teriparatide for 7 days, plus calcium and calcitriol for 7 days. There is an equal chance of getting assigned to any of these 4 groups, for the first 40 participants enrolled on this study. If enrolled after that point, participants will have a greater chance of being assigned to the group showing the best results.
Standard-of-Care Group:
If assigned to the standard-of-care group, participant will receive calcium and calcitriol according to the standard schedule and dose. The calcium will either be given through a vein or by mouth, and calcitriol will be given by mouth.
Teriparatide Group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled for total thyroidectomy, and/or extensive neck dissections (pharyngectomy, laryngectomy, unilateral/bilateral/central neck, and/or mediastinal lymph node neck dissections).
- •Patients who develop, between 18-24 hours after surgery, hypocalcemia as defined by a corrected serum calcium <8.0mg/dL. [Corrected serum calcium (mg/dL) = Measured calcium + (4-albumin) x 0.8]
排除标准
- •Patients who have jejunal tubes
- •Patients <18 years old.
- •Treatment with teriparatide or calcitriol (Rocaltrol) within 1 month prior to surgery
- •Treatment with a bisphosphonate within 3 months prior to surgery
- •Hypercalcemia (corrected serum calcium >10.5mg/dL) or hypocalcemia (corrected serum calcium <8.4mg/dL) on preoperative labs (drawn within 21 days of surgery)
- •Paget's disease of bone
- •Elevated alkaline phosphatase > institutional upper limit of normal (ULN)
- •History of external beam irradiation to the skeleton
- •History of skeletal metastases
- •History of untreated gout
- •History of unstable angina pectoris
- •History of symptomatic orthostatic hypotension
- •Pregnancy (as screened by a serum/urine pregnancy test) or breast-feeding. Female subjects of childbearing potential must have a negative pregnancy test within 7 days of surgery. Postmenopausal women (absence of menses for 12 months) or women with history of hysterectomy or bilateral oophorectomy will not be required to have a pregnancy test. Male and female patients of reproductive potential must agree to utilize an effective form of contraception throughout the study period. The definition of effective contraception will be based on the judgment of the Investigator or designated associate.
- •Hepatic and renal dysfunction defined by the following parameters: (a) Serum AST (SGOT) and ALT (SGPT) > 3 times the institutional ULN, (b) Total serum bilirubin > 2 times the institutional ULN, (c) Serum creatinine > 1.5mg/dL or estimated creatinine clearance < 40mL/min
- •Psychiatric illness or social situation that would limit compliance with study requirements
- •Concomitant use of digoxin
- •Patients may not be receiving any other investigational agents or have participated in any investigational drug study within 28 days preceding the start of study treatment.
研究组 & 干预措施
Calcium + Calcitriol
1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcium (Drug)
Calcium + Calcitriol
1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcitriol (Drug)
Teriparatide 20 mcg
Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Teriparatide (Forteo) (Drug)
Teriparatide 20 mcg
Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcium (Drug)
Teriparatide 20 mcg
Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcitriol (Drug)
Teriparatide 40 mcg
Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Teriparatide (Forteo) (Drug)
Teriparatide 40 mcg
Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcium (Drug)
Teriparatide 40 mcg
Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcitriol (Drug)
Teriparatide 60 mcg
Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Teriparatide (Forteo) (Drug)
Teriparatide 60 mcg
Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcium (Drug)
Teriparatide 60 mcg
Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
干预措施: Calcitriol (Drug)
结局指标
主要结局
Number of Patients With Success
时间窗: 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.
次要结局
未报告次要终点