Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery (ExtenD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Kerstyn C. Zalesin, M.D., William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01138475
First received: June 4, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Gastric Bypass
Parathyroid Hormone
Drug: Paricalcitol
Drug: Cholecalciferol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • The primary efficacy variable is change from baseline in iPTH over 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vitamin and mineral levels and laboratory surveillance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    All other laboratories done on the basis of clinical care are organized into pre-operative and post-operative Laboratory Panels. The pre-operative laboratory values will be obtained from BRL database for screening purposes. In all bariatric patients, 25-hydroxy vitamin D and 1,25-dihydroxy vitamin D will be measured in every subject at entry into the program. Laboratory measures available include a biochemistry profile (includes serum Cr, blood urea nitrogen, and eGFR by the 4-variable MDRD equation which will not be blinded).


Estimated Enrollment: 75
Study Start Date: July 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paricalcitol
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).
Drug: Paricalcitol
1 microgram by mouth daily for 6 weeks
Active Comparator: cholecalciferol
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).
Drug: Cholecalciferol
5000 IU (international units) by mouth daily for 6 weeks
Placebo Comparator: placebo
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).
Drug: Placebo
Inactive substance, one capsule daily for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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):
    • 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)

Exclusion Criteria:

  • . 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.

    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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138475

Locations
United States, Michigan
William Beaumont Health Center
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kerstyn C. Zalesin, M.D.
Abbott
Investigators
Principal Investigator: Kerstyn Zalesin, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kerstyn C. Zalesin, M.D., Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01138475     History of Changes
Other Study ID Numbers: 2009-234
Study First Received: June 4, 2010
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
PTH
Gastric bypass surgery
vitamin D
paricalcitol

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Endocrine System Diseases
Parathyroid Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014