Gastric BypassPhase 3ExtenDNCT01138475
Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery
A Phase 3 study testing Paricalcitol and Cholecalciferol in people with Gastric Bypass and Parathyroid Hormone, run by Kerstyn C. Zalesin, M.D. at 1 site in United States.
Trial summary
Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess changes, if any, in measures of self-assessed well-being attributable to paricalcitol after RYGB. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Bypass, Parathyroid Hormone
- What is being tested?
- Paricalcitol and Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2015
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
- 2. Must be post bariatric (> 6 weeks and ≤ 5 years) Rou-en-Y gastric bypass surgical patient.
- 3. Male or female subjects > 18 years. 4. For entry into the Treatment Period the subject must satisfy the following criteria based on the existing laboratory values previously drawn on clinical grounds:
- Serum calcium level 8.0-10.5 mg/dL
- Phosphorous level < 5.2 mg/dL (1.68 mmol/L)
- Serum albumin > 3.0 g/dL (30 g/L). 5. For entry into the Treatment Period the subject must satisfy the following criteria based on screening laboratories (Beaumont Reference Laboratories, screening laboratory values are not blinded):
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- iPTH > 69 pg/ml
- Negative serum pregnancy test for female subjects of childbearing potential. 6. In the opinion of the investigator, the subject must be receiving optimal medical management of other co morbidities including but not limited to HTN, DM, CVD, liver disease, and lung disease.
- 7. If female, subject is not breast feeding or is not pregnant (verified by negative pregnancy test prior to the Treatment Period); or is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or is of childbearing potential and practicing one of the following methods of birth control:
- Double-barrier method (any two of the following: condoms, contraceptive sponge, diaphragm, vaginal ring with spermicidal jellies or creams, or intrauterine device [IUD])
- Hormonal contraceptives (oral, parenteral, or transdermal) for at least three months prior to and during study drug administration
- Maintains a monogamous relationship with a vasectomized partner
- Total abstinence from sexual intercourse during the study (minimum one complete menstrual cycle prior to study start)
Who cannot join
- . Subject has previously been on active vitamin D therapy (calcitriol, paricalcitol, doxercalciferol, alfacalcidol) within the 30-day washout period prior to the Treatment Period at doses greater than 1200 IU of vitamin D3 or equivalent.
- 2. Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug (i.e., vitamin D or vitamin D related compounds).
- 3. Pregnant (confirmed by screening pregnancy test) or lactating females. 4. Subject is expected to initiate renal replacement therapy within one year. 5. Known history of hypercalcemia (>10.5 mg/dl), hyperphosphatemia (>6 mg/dl) primary hyperparathyroidism, or history of end-stage renal disease requiring renal replacement therapy.
- 6. Full remission from a malignancy for less than one year (except completely excised non-Melanoma skin cancer e.g., basal or squamous carcinoma) or any history of bone metastasis.
- 7. Subject has co-morbid conditions (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than 1 year.
- 8. Subject has received any investigational drug within 30 days prior to study drug administration or is currently enrolled in another clinical trial.
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- 9. Subject has a history of active kidney stones within the 2 years prior to the Screening Period.
- 10. Subject has poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg at the Screening Visit (confirmed by repeat).
- 11. Subject has history of renal artery stenosis, primary aldosteronism or pheochromocytoma, 12. Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids), or other drugs that may affect calcium or bone metabolism, other than aluminum, calcium and non-calcium containing phosphate binders or female subjects on stable (same dose and product for three months) estrogen and/or progestin therapy.
- 13. Subject is currently receiving immunosuppressant therapy and/or high doses (non-maintenance therapy) of glucocorticoids (> 5 mg/day of prednisone or equivalent).
- 14. Subject has had acute renal failure within 12 weeks of the Screening Phase defined by an acute rise in serum Cr (of at least 0.5 mg/dL or 44 micromoles/L) to more than 4 g/dL (350 micromoles/L).
- 15. Subject is known to be HIV positive. 16. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome P450 3 A (CYP3 A) within two weeks prior to study drug administration.
- 17. For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
- 18. Subject has a history of drug or alcohol abuse within six months prior to screening.
- 19. Subject has had a liver or kidney transplant. 20. Stage V CKD subjects on renal replacement therapy are explicitly excluded. 21. Subject has had a CVA within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Health Center
Royal Oak, Michigan, 48073
About this study
Official title: A Prospective, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Pilot Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery
Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess changes, if any, in measures of self-assessed well-being attributable to paricalcitol after RYGB. Evaluate the rates of hypercalcemia, kidney stones, gastrointestinal side effects, and other organ system adverse effects of paricalcitol, cholecalciferol, and placebo in patients after RYGB
- Conditions
- Gastric Bypass, Parathyroid Hormone
- Being tested
- Paricalcitol, Cholecalciferol, Placebo
- Keywords
- PTH, Gastric bypass surgery, vitamin D, paricalcitol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
1 microgram by mouth daily for 6 weeks
CholecalciferolDrug
5000 IU (international units) by mouth daily for 6 weeks
PlaceboDrug
Inactive substance, one capsule daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Active comparator | This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). Receives: Drug: Paricalcitol |
| cholecalciferol | Active comparator | This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). Receives: Drug: Cholecalciferol |
| placebo | Placebo comparator | This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure With iPTH
Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study
Measured: 6 weeks
Secondary outcomes (8)
Alkaline Phosphatase
This secondary outcome measure is change in alkaline phosphatase from baseline to final measure at 6 weeks differences were compared between the 3 arms of the study
Measured: 6 weeks
Serum Calcium
This secondary outcome measure is change in serum calcium from baseline to final measure at 6 weeks differences in the 3 arms were compared
Measured: 6 weeks
Serum 25 OH Vitamin D
This secondary outcome measure is change in serum hydroxy-vitaminD from baseline to final measure at 6 weeks differences in the 3 arms were compared
Measured: 6 weeks
Serum Phosphorus
This secondary outcome measure is change in serum phosphorus from baseline to final measure at 6 weeks differences in the 3 arms were compared
Measured: 6 weeks
Osteocalcin
This secondary outcome measure is change in osteocalcin from baseline to final measure at 6 weeks differences in the 3 arms were compared
Measured: 6 weeks
N-Telopeptide Cross Linked Urine
This secondary outcome measure is change in N-Telopeptide cross linked urine from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Measured: 6 weeks
Bone Specific Alkaline Phosphatase
This secondary outcome measure is change in bone specific alkaline phosphatase from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Measured: 6 weeks
24 Hour Urine Calcium
This secondary outcome measure is change in 24-hour urine calcium from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2015
- Study completionAug 2015
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 Gastric BypassStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerstyn C. Zalesin, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Kerstyn C. Zalesin, M.D., Corewell Health East
- Investigators
- Kerstyn Zalesin, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138475
- Sponsor's protocol ID
- 2009-234
- Acronym
- ExtenD
- Status last verified
- Aug 2016
- First submitted
- 4 Jun 2010
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Pilot Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT01138475
- Acronym / sponsor ID
- ExtenD / 2009-234
- Conditions
- Gastric Bypass, Parathyroid Hormone
- Keywords
- PTH, Gastric bypass surgery, vitamin D, paricalcitol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kerstyn C. Zalesin, M.D.University, hospital or other
- Collaborators
- Abbott
- Study start
- Jul 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Posted 22 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess changes, if any, in measures of self-assessed well-being attributable to paricalcitol after RYGB. Evaluate the rates of hypercalcemia, kidney stones, gastrointestinal side effects, and other organ system adverse effects of paricalcitol, cholecalciferol, and placebo in patients after RYGB
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Active comparator | Drug: ParicalcitolThis is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). |
| cholecalciferol | Active comparator | Drug: CholecalciferolThis is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). |
| placebo | Placebo comparator | Drug: PlaceboThis is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
- 2. Must be post bariatric (> 6 weeks and ≤ 5 years) Rou-en-Y gastric bypass surgical patient.
- 3. Male or female subjects > 18 years. 4. For entry into the Treatment Period the subject must satisfy the following criteria based on the existing laboratory values previously drawn on clinical grounds:
- 7. If female, subject is not breast feeding or is not pregnant (verified by negative pregnancy test prior to the Treatment Period); or is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or is of childbearing potential and practicing one of the following methods of birth control:
Key exclusion criteria (15 listed)
- . Subject has previously been on active vitamin D therapy (calcitriol, paricalcitol, doxercalciferol, alfacalcidol) within the 30-day washout period prior to the Treatment Period at doses greater than 1200 IU of vitamin D3 or equivalent.
- 2. Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug (i.e., vitamin D or vitamin D related compounds).
- 3. Pregnant (confirmed by screening pregnancy test) or lactating females. 4. Subject is expected to initiate renal replacement therapy within one year. 5. Known history of hypercalcemia (>10.5 mg/dl), hyperphosphatemia (>6 mg/dl) primary hyperparathyroidism, or history of end-stage renal disease requiring renal replacement therapy.
- 6. Full remission from a malignancy for less than one year (except completely excised non-Melanoma skin cancer e.g., basal or squamous carcinoma) or any history of bone metastasis.
- 7. Subject has co-morbid conditions (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than 1 year.
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 |
|---|---|---|
| Paricalcitol1 microgram by mouth daily for 6 weeks | Drug | Paricalcitol |
| Cholecalciferol5000 IU (international units) by mouth daily for 6 weeks | Drug | cholecalciferol |
| PlaceboInactive substance, one capsule daily for 6 weeks | Drug | placebo |
Primary outcome
The Primary Outcome Measure With iPTH
Time frame: 6 weeks
Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study
8 secondary outcomes
Alkaline Phosphatase
Time frame: 6 weeks
Serum Calcium
Time frame: 6 weeks
Serum 25 OH Vitamin D
Time frame: 6 weeks
Serum Phosphorus
Time frame: 6 weeks
Osteocalcin
Time frame: 6 weeks
N-Telopeptide Cross Linked Urine
Time frame: 6 weeks
Bone Specific Alkaline Phosphatase
Time frame: 6 weeks
24 Hour Urine Calcium
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kerstyn Zalesin, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paricalcitol and Cholecalciferol in people with Gastric Bypass and Parathyroid Hormone, run by Kerstyn C. Zalesin, M.D. 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 13 inclusion and 15 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: finished, as of the sponsor's last update on 22 Mar 2017. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 Mar 2017). 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?
The Primary Outcome Measure With iPTH (time frame: 6 weeks). 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 22 Mar 2017.