Primary Hyperparathyroidism (PHPT): Early Effect of Vitamin D

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01329666
First received: April 4, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people every year. In the presence of this condition, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by excess calcium loss which weakens bone structure. Other affected organs include the skeleton (calcium loss leads to a "weakening" of the skeleton), and the kidneys (high blood calcium can lead to kidney stones).

It is now evident that the majority of patients with even mild Primary Hyperparathyroidism are vitamin D deficient. In 2009, new international guidelines for the management of asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml). However, no recommendations for vitamin D repletion are given, because of limited data regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there is an urgent need for data upon which to base such recommendations, as well as are data on the effects of such treatment upon bones.

Subjects with low vitamin D3 levels will be selected for this trial. They will be given enough vitamin D3 to raise their low blood levels from a low to a normal range. The assessments in this study, including the quadruple label bone biopsy, will allow us to document the short term effects of administering vitamin D3 on changes in bone.

All participants enrolled in this trial will be vitamin D3 deficient. Participants will take an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo will be initiated. Six of 7 participants will receive the study drug (active vitamin D3), while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism.

There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy will be performed.

Study Procedures:

Medical and Social History

Blood tests (drawn at the study center and local Quest Lab)

24-Hour urine collection for calcium and creatinine excretion

Abdominal X-ray (to assess for kidney stones)

Transiliac crest Bone Biopsy


Condition Intervention Phase
Primary Hyperparathyroidism
Hypercalcemia
Vitamin D Deficiency
Osteoporosis
Osteopenia
Dietary Supplement: Placebo
Dietary Supplement: Vitamin D3
Phase 2
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)
Official Title: Early Effect of Vitamin D in Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in Bone Formation Rate (BFR) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    A between group (vitamin D3 vs. placebo) comparison of BFR will be performed at three surfaces, cancellous, intra- and endo-cortical.


Estimated Enrollment: 35
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50,000 IU Vitamin D3 Dietary Supplement: Vitamin D3

Baseline:

50,000 IU/week for 8 weeks

Week 8:

Subjects with D3 less than 30 ng/ml: 50,000 IU/week for 4 weeks.

Subjects with D3 25-OHD at or above 30 ng/ml: 50,000 IU/every 2 weeks for 4 weeks.

Placebo Comparator: Placebo (inactive Vitamin D3) Dietary Supplement: Placebo
Subjects will receive placebo vitamin D3, 1 pill weekly for 12 weeks.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females and males >= 45 years of age
  2. PHPT, defined as elevated PTH with elevated serum calcium
  3. Screening 25-OHD <= 20 ng/ml

Exclusion Criteria:

  1. Pre-menopausal
  2. Serum calcium is >11.5mg/dl.
  3. Urinary calcium is >350 mg/dl.
  4. Active nephrolithiasis
  5. Nephocalcinosis
  6. Known sensitivity to tetracycline (Sumycin)
  7. Familial history of hyperparathyroid syndromes
  8. Bisphosphonate use within past 2 years.
  9. Current use of Prolia.
  10. Current use of Cinacalcet.
  11. Currently using Cimetidine.
  12. Currently use Colestipol.
  13. Currently using Orlistat.
  14. Current or past malignancy, except cured basal or squamous cell skin carcinoma or other cancers that have not recurred for at least five years.
  15. Current tuberculosis, or history of Sarcoidosis, HIV/AIDS, chronic kidney disease (serum creatinine >= 1.5), liver disease, Crohn's Disease, Celiac Disease, or gastric bypass
  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: NCT01329666

Contacts
Contact: Anita . Tierney, MPH 212-342-5231 art23@columbia.edu
Contact: Julia O. Udesky 212-305-2900 jou2101@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Shonni J. Silverberg, MD         
Sub-Investigator: Marcella D. Walker, MD, MS         
Sub-Investigator: Elizabeth Shane, MD         
Sub-Investigator: Dinaz Irani, MD         
Sub-Investigator: Mishaela Rubin, MD         
Sub-Investigator: Angela Carelli, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Shonni J. Silverberg, MD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01329666     History of Changes
Other Study ID Numbers: AAAF1846, R01DK084986
Study First Received: April 4, 2011
Last Updated: October 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Primary Hyperparathyroidism
Endocrinology
Hypercalcemia
Vitamin D deficiency
Parathyroid Hormone
Osteoporosis
Bone Density
Vitamin D repletion
Vitamin D Supplements

Additional relevant MeSH terms:
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Osteoporosis
Vitamin D Deficiency
Avitaminosis
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Endocrine System Diseases
Malnutrition
Metabolic Diseases
Musculoskeletal Diseases
Nutrition Disorders
Parathyroid Diseases
Water-Electrolyte Imbalance
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