Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Fatigue

Breast Neoplasms

Arthralgia

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Vitamins

Letrozole

Vitamin D

Cholecalciferol

Aromatase Inhibitors

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).

Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).

High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.

High Dose Vitamin D

Placebo

Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

Standard Dose Vitamin D3

All subjects received letrozole as standard of care.

Letrozole 2.5mg

Qamar J Khan, MD

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).

Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.

Novartis Pharmaceuticals

BTR Group

Qamar Khan

Associate Professor

Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.

Placebo (3 capsules of matching placebo) along with standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks

High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly

Placebo (3 capsules of matching placebo weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

High Dose Vitamin D3 (3 capsules of 10,000 IU weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Bruce Kimler

HAQ II increase by 0.25

Subjective Pain increase

Discontinuation due to AEs

Any of the three measures

High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks

Subjects available for analysis included those that had completed the entire study; plus three subjects that had dropped out early specifically because of side effects related to musculoskeletal symptoms (one of the endpoints).

Number of Participants With Worsening of Musculoskeletal Symptoms (MS)

Placebo (3 capsules of matching placebo given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

High Dose Vitamin D3 (3 capsules of 10,000 IU given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

Spots Global Cancer Trial Database for standard dose vitamin d3