Vitamin D Repletion in Primary Hyperparathyroidism

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Columbia University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Shonni J. Silverberg, Columbia University
ClinicalTrials.gov Identifier:
NCT01306656
First received: February 10, 2011
Last updated: April 13, 2016
Last verified: April 2016
  Purpose
This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.

Condition Intervention Phase
Primary Hyperparathyroidism
Vitamin D Deficiency
Dietary Supplement: 10,000 IU Vitamin D3
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Serum Parathyroid hormone level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone-specific alkaline phosphatase [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Areal bone mineral density of the lumbar spine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by DXA

  • Trabecular bone density at the forearm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by high resolution peripheral quantitative computed tomography

  • Volumetric bone density of the spine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessed by central quantitative computed tomography

  • Elastic Stiffness at the radius as assessed by finite element analysis of HRpQCT images [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Elastic stiffness will be calculated from HRpQCT images of distal radius and distal tibia and converted to a µFE model.

  • Serum Calcium Concentration [ Time Frame: Month 1, 3, 6 ] [ Designated as safety issue: Yes ]
    Participants whose serum calcium concentration rise above 12 milligrams per deciliter (mg/dL) will stop study medications

  • Urinary Calcium Level [ Time Frame: Month 1, 3, 6 ] [ Designated as safety issue: Yes ]
    Urinary calcium > 400 milligrams/day (mg/d)

  • Number of participants that developed nephrolithiasis [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: Yes ]
    Participants who develop nephrolithiasis will stop study medications

  • Serum C-terminal telopeptide of type I collagen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Areal bone mineral density of the hip [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by DXA

  • Trabecular bone density at the tibia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by high resolution peripheral quantitative computed tomography

  • Cortical bone density of the radius [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by high resolution peripheral quantitative computed tomography

  • Cortical bone density at the tibia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by high resolution quantitative computed tomography

  • Volumetric bone density of the hip [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by central quantitative computed tomography

  • Elastic Stiffness at the tibia as assessed by finite element analysis of HRpQCT images [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of participants achieving a serum vitamin D level greater than or equal to 30 nanograms per milliliter [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D
Dietary Supplement: 10,000 IU Vitamin D3

Month 1: 20,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.

Months 2-6: 10,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.

Placebo Comparator: Group 2
Placebo plus a multivitamin with 400 IU vitamin D
Dietary Supplement: Placebo

Month 1: Placebo once a week plus daily multivitamin with 400 IU vitamin D.

Months 2-6: Placebo every week plus daily multivitamin with 400 IU vitamin D.


Detailed Description:

Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones.

Many patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D is repletion.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.
  • Vitamin D3 less than 30 ng/ml

Exclusion Criteria:

  • Patients with familial hyperparathyroid syndromes
  • Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat
  • Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence
  • History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine > 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);
  • We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria
  • Other exclusions include protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.
  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: NCT01306656

Contacts
Contact: Marcella Walker, MD 212-305-7225 mad2037@columbia.edu
Contact: Mariana Bucovsky 212-305-7225 mb3523@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Marcella Walker, BA    212-305-7225    mad2037@columbia.edu   
Principal Investigator: Shonni J. Silverberg, MD         
Sub-Investigator: Angela Carelli, MD         
Sub-Investigator: Marcella D. Walker, MD, MS         
Sub-Investigator: Elizabeth Shane, MD         
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Shonni J Silverberg, MD Columbia University
  More Information

Responsible Party: Shonni J. Silverberg, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01306656     History of Changes
Other Study ID Numbers: AAAF1797  R01DK084986-01A 
Study First Received: February 10, 2011
Last Updated: April 13, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Endocrinology
Metabolic Bone Disease
Primary Hyperparathyroidism
PHPT
Vitamin D Deficiency
Bone Mineral Density
Hyper-calcemia

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Hyperparathyroidism
Vitamin D Deficiency
Parathyroid Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 23, 2016