Effects of High Dose Calcitriol in Breast Cancer Patients

March 30, 2022 updated by: Luke Peppone, University of Rochester

A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery

This research will examine the effectiveness of calcitriol in treating bone loss in women who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The calcitriol intervention is aimed at reducing fracture risk by maintaining proper bone density. Calcitriol is efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients. In addition, calcitriol may be effective in reducing tumor proliferation and angiogenesis, while increasing tumor apoptosis. Each of those factors could have beneficial effects on breast cancer outcomes.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Must be female.
  • Must have pathologically confirmed incident, primary invasive breast cancer.
  • Must be awaiting surgical resection.
  • Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.
  • Must provide informed consent.
  • Must be willing to discontinue use of calcium and/or vitamin D supplements other than multivitamin supplementation.
  • Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.

Exclusion Criteria:

  • Subjects with life-threatening conditions that would preclude them from breast cancer treatment including: chronic cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease.
  • Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
  • Patients with a previous history of any other cancer except non-melanomous skin cancer within the past 5 years.
  • Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
  • Patients with hypercalcemia (corrected serum CA > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
  • Patients currently taking calcium supplements or aluminum-based antacids must immediately discontinue their use if they are to enroll in the study.
  • Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.
  • Patients with a known sensitivity to calcitriol.
  • Women who are pregnant or lactating.
  • Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
  • Women currently using oral contraception.
  • Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).
  • Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcitriol
Calcitriol 45mcg/week
Drug: Calcitriol
In pill form, 45 micrograms once a week for 12 weeks
Other Names:
  • Rocatrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Bone Resorption: NTX (N-terminal Telopeptide)
Time Frame: baseline to 12 weeks
Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome.
baseline to 12 weeks
Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase)
Time Frame: baseline to 12 weeks
Scale score for BAP (Bone-specific alkaline phosphatase) minimum value = 7 mcg/L; maximum value = 329 mcg/L Higher scale score for BAP indicates worse outcome.
baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Luke J Peppone, PhD, University of Rochester
  • Study Director: Joseph J Guido, MS, Univ of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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