Effects of High Dose Calcitriol in Breast Cancer Patients

NCT01293682 | Completed Phase 2 Results DMC

• 1 other identifier: 25741
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Mean Change in Bone Resorption: NTX (N-terminal Telopeptide)

  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)

  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

Study Arms (1)

Calcitriol

EXPERIMENTAL

Calcitriol 45mcg/week

Drug: Calcitriol

Interventions

Calcitriol DRUG

In pill form, 45 micrograms once a week for 12 weeks

Also known as: Rocatrol

Calcitriol

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Luke J Peppone, PhD, MPH
• Organization: University of Rochester

Luke_Peppone@urmc.rochester.edu

585-275-7827

Study Officials

• Luke J Peppone, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Joseph J Guido, MS

  Univ of Rochester

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: November 1, 2010
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2021
• Last Updated: April 20, 2022
• Results First Posted: February 7, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)