Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center Eli Lilly and Company |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00623974 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypocalcemia |
Drug: Teriparatide (Forteo) Drug: Calcium Drug: Calcitriol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia |
Estimated Enrollment: | 500 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Calcium + Calcitriol
|
Drug: Calcium
1000 milligrams PO Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
|
2: Experimental
Teriparatide at 20 mcg + Calcium + Calcitriol
|
Drug: Teriparatide (Forteo)
Subcutaneous Injection Every 12 Hours for 7 Days
Drug: Calcium
1000 milligrams PO Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
|
3: Experimental
Teriparatide at 40 mcg + Calcium + Calcitriol
|
Drug: Teriparatide (Forteo)
Subcutaneous Injection Every 12 Hours for 7 Days
Drug: Calcium
1000 milligrams PO Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
|
4: Experimental
Teriparatide at 60 mcg + Calcium + Calcitriol
|
Drug: Teriparatide (Forteo)
Subcutaneous Injection Every 12 Hours for 7 Days
Drug: Calcium
1000 milligrams PO Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mimi Hu, MD | 713-792-2841 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Mimi Hu, MD |
Principal Investigator: | Mimi Hu, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Mimi Hu, MD/Assistant Professor ) |
Study ID Numbers: | 2006-0562 |
Study First Received: | February 14, 2008 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00623974 |
Health Authority: | United States: Food and Drug Administration |
Hypocalcemia Teriparatide Forteo |
Calcium Calcitriol Rocaltrol |
Calcium, Dietary Hypocalcemia Metabolic Diseases Teriparatide |
Water-Electrolyte Imbalance Metabolic disorder Calcitriol |
Calcium Channel Agonists Calcium Metabolism Disorders Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Cardiovascular Agents |
Pharmacologic Actions Membrane Transport Modulators Vitamins Therapeutic Uses Vasoconstrictor Agents Micronutrients |