HypocalcemiaPhase 2NCT00623974
Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
A Phase 2 study testing Teriparatide (Forteo), Calcium and Calcitriol in people with Hypocalcemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia
- What is being tested?
- Teriparatide (Forteo), Calcium and Calcitriol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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:
If assigned to a teriparatide group, participant will receive teriparatide by an injection under the skin, twice a day for 7 days. They will be taught how to perform the injections themselves, with a pen-sized device. While in the hospital, the hospital staff will watch them perform the injections and offer help, if needed. If discharged from the hospital and sent home before the 7 days of therapy are complete, they will continue giving themselves the injections (through Day 7) at home. The pen should not be removed from refrigeration for more than 2 -4 hours. Depending on what dose level of teriparatide assigned to receive, they may have to give themselves up to 3 injections each time. In addition to teriparatide, they 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 by mouth.
Both Groups:
If blood calcium level has not returned to normal after the 7 days of treatment, participants may need to continue receiving calcium and/or calcitriol for as long as the doctor decides it is necessary.
They will be asked to keep a medication log (diary) of when they take the teriparatide and/or calcium/calcitriol. The log should be returned to the research nurse on Day 8.
On Days 1-7, blood will be drawn to check the level of calcium twice a day (while in the hospital) or once a day (while treated as an outpatient). These blood draws (about 1 teaspoon each time) will be performed 2 hours before receiving teriparatide and/or calcium/calcitriol.
Blood will also be drawn to check calcium and parathyroid hormone levels after the study treatment is over. The first of these blood draws (about 1 tablespoon each time) will be performed at 3 days after receiving last dose of teriparatide and/or last dose of calcium/calcitriol. The second blood draw will be performed at 4 weeks after the surgery.
Starting on Day 7, and again at 4 weeks after surgery, they will be asked to collect urine over the course of a 24-hour period so calcium levels can be measured.
From Day 1 to Day 7, if discharged from the hospital and sent home, the study personnel will call on the phone once a day to see how participants are doing. At 3 days after receiving the last dose of teriparatide and/or the last dose of calcium/calcitriol, and at 4 weeks after the surgery, they will be called again.
After the urine collection, blood draw, and phone call at 4 weeks after the surgery, participation in the study is over.
- Conditions
- Hypocalcemia
- Being tested
- Teriparatide (Forteo), Calcium, Calcitriol
- Keywords
- Hypocalcemia, Teriparatide, Forteo, Calcium, Calcitriol, Rocaltrol
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teriparatide (Forteo)Drug
Also called Forteo, PTH, Parathyroid Hormone
Subcutaneous Injection Every 12 Hours for 7 Days
CalciumDrug
1000 milligrams by mouth (PO) Every 12 Hours
CalcitriolDrug
Also called Rocaltrol
0.25 micrograms PO Every 12 Hours
| Study group | Role | What they receive |
|---|---|---|
| Calcium + Calcitriol | Experimental | 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours Receives: Drug: Calcium; Drug: Calcitriol |
| Teriparatide 20 mcg | Experimental | Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours Receives: Drug: Teriparatide (Forteo); Drug: Calcium; Drug: Calcitriol |
| Teriparatide 40 mcg | Experimental | Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours Receives: Drug: Teriparatide (Forteo); Drug: Calcium; Drug: Calcitriol |
| Teriparatide 60 mcg | Experimental | Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours Receives: Drug: Teriparatide (Forteo); Drug: Calcium; Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Success
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.
Measured: 2 - 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Mimi Hu, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623974
- Sponsor's protocol ID
- 2006-0562
- Status last verified
- Dec 2012
- First submitted
- 14 Feb 2008
- Last updated
- 6 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
- ClinicalTrials.gov ID
- NCT00623974
- Acronym / sponsor ID
- 2006-0562
- Conditions
- Hypocalcemia
- Keywords
- Hypocalcemia, Teriparatide, Forteo, Calcium, Calcitriol, Rocaltrol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- May 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Posted 13 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
If assigned to a teriparatide group, participant will receive teriparatide by an injection under the skin, twice a day for 7 days. They will be taught how to perform the injections themselves, with a pen-sized device. While in the hospital, the hospital staff will watch them perform the injections and offer help, if needed. If discharged from the hospital and sent home before the 7 days of therapy are complete, they will continue giving themselves the injections (through Day 7) at home. The pen should not be removed from refrigeration for more than 2 -4 hours. Depending on what dose level of teriparatide assigned to receive, they may have to give themselves up to 3 injections each time. In addition to teriparatide, they 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 by mouth.
Both Groups:
If blood calcium level has not returned to normal after the 7 days of treatment, participants may need to continue receiving calcium and/or calcitriol for as long as the doctor decides it is necessary.
They will be asked to keep a medication log (diary) of when they take the teriparatide and/or calcium/calcitriol. The log should be returned to the research nurse on Day 8.
On Days 1-7, blood will be drawn to check the level of calcium twice a day (while in the hospital) or once a day (while treated as an outpatient). These blood draws (about 1 teaspoon each time) will be performed 2 hours before receiving teriparatide and/or calcium/calcitriol.
Blood will also be drawn to check calcium and parathyroid hormone levels after the study treatment is over. The first of these blood draws (about 1 tablespoon each time) will be performed at 3 days after receiving last dose of teriparatide and/or last dose of calcium/calcitriol. The second blood draw will be performed at 4 weeks after the surgery.
Starting on Day 7, and again at 4 weeks after surgery, they will be asked to collect urine over the course of a 24-hour period so calcium levels can be measured.
From Day 1 to Day 7, if discharged from the hospital and sent home, the study personnel will call on the phone once a day to see how participants are doing. At 3 days after receiving the last dose of teriparatide and/or the last dose of calcium/calcitriol, and at 4 weeks after the surgery, they will be called again.
After the urine collection, blood draw, and phone call at 4 weeks after the surgery, participation in the study is over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calcium + Calcitriol | Experimental | Drug: Calcium, Drug: Calcitriol1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours |
| Teriparatide 20 mcg | Experimental | Drug: Teriparatide (Forteo), Drug: Calcium, Drug: CalcitriolTeriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours |
| Teriparatide 40 mcg | Experimental | Drug: Teriparatide (Forteo), Drug: Calcium, Drug: CalcitriolTeriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours |
| Teriparatide 60 mcg | Experimental | Drug: Teriparatide (Forteo), Drug: Calcium, Drug: CalcitriolTeriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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]
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teriparatide (Forteo)Also: Forteo, PTH, Parathyroid HormoneSubcutaneous Injection Every 12 Hours for 7 Days | Drug | Teriparatide 20 mcg, Teriparatide 40 mcg, Teriparatide 60 mcg |
| Calcium1000 milligrams by mouth (PO) Every 12 Hours | Drug | Calcium + Calcitriol, Teriparatide 20 mcg, Teriparatide 40 mcg, Teriparatide 60 mcg |
| CalcitriolAlso: Rocaltrol0.25 micrograms PO Every 12 Hours | Drug | Calcium + Calcitriol, Teriparatide 20 mcg, Teriparatide 40 mcg, Teriparatide 60 mcg |
Primary outcome
Number of Patients With Success
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mimi Hu, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriparatide (Forteo), Calcium and Calcitriol in people with Hypocalcemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Success (time frame: 2 - 7 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.