Trial record 8 of 44 for:    "familial isolated hyperparathyroidism" OR "Hyperparathyroidism, Primary"

Vitamin D Repletion in Primary Hyperparathyroidism

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shonni J. Silverberg, Columbia University
ClinicalTrials.gov Identifier:
NCT01306656
First received: February 10, 2011
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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. This study will compare three vitamin D regimens to determine if vitamin D supplementation improves the biochemical features of primary hyperparathyroidism as well as bone density, bone microarchitecture and bone strength. Additionally, we will determine which regimen results in the greatest improvement.


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)

  • 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: June 2016
Estimated Primary Completion Date: June 2015 (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:

Study Design

40 patients with PHPT and vitamin D deficiency (25OHD less than 30 nanograms/milliliter (ng/ml)) will be enrolled and randomized 4:1 to 2 different vitamin D repletion regimens: 1) 20,000 international units (IU) vitamin D3/week for 4 weeks plus a daily multivitamin with 400 IU vitamin D, followed by 10,000 IU vitamin D/week plus a daily multivitamin for 5 months 2) placebo plus a daily multivitamin with 400 IU vitamin D for 6 months.

Study Procedures

  1. Blood tests
  2. Urine calcium excretion
  3. Bone Mineral Densitometry assessed with dual x-ray absorptiometry (DXA)
  4. High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT), which provides measures of volumetric density and bone size, and microarchitecture at the forearm and tibia
  5. Central Quantitative Computed Tomography (cQCT) of the spine and hip
  6. Abdominal X-ray to asses for nephrolithiasis
  Eligibility

Ages Eligible for Study:   18 Years and older
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: Anna Kepley 212-342-5231 alk2086@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 Donovan Walker, MD, MS         
Sub-Investigator: Elizabeth Shane, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Shonni J Silverberg, MD Columbia University
  More Information

No publications provided

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: July 2, 2014
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
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014