Trial Outcomes & Findings for Vitamin D3 for Aromatase Inhibitor Induced Arthralgias (NCT NCT00867217)
NCT ID: NCT00867217
Last Updated: 2018-02-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Change from Baseline to 24 Weeks
Results posted on
2018-02-09
Participant Flow
Participant milestones
| Measure |
Placebo
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.
|
Vitamin D
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.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
77
|
70
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D3 for Aromatase Inhibitor Induced Arthralgias
Baseline characteristics by cohort
| Measure |
Placebo
n=80 Participants
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.
|
Vitamin D
n=80 Participants
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
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
62 years
n=5 Participants
|
60.5 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
80 participants
n=7 Participants
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 24 WeeksPopulation: 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).
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
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
|
Vitamin D
n=70 Participants
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
|
|---|---|---|
|
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
HAQ II increase by 0.25
|
23 participants
|
18 participants
|
|
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
Subjective Pain increase
|
24 participants
|
18 participants
|
|
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
Discontinuation due to AEs
|
3 participants
|
0 participants
|
|
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
Any of the three measures
|
39 participants
|
26 participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
Vitamin D
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=80 participants at risk
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
|
Vitamin D
n=80 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Cardiac Changes
|
0.00%
0/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
1.2%
1/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Nervous system disorders
CNS Ischemia
|
1.2%
1/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
0.00%
0/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
0.00%
0/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.2%
1/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
0.00%
0/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Cardiac disorders
Supraventricular arryhthmia
|
0.00%
0/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
1.2%
1/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Skin and subcutaneous tissue disorders
Wound Complications
|
0.00%
0/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
1.2%
1/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
Other adverse events
| Measure |
Placebo
n=80 participants at risk
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
|
Vitamin D
n=80 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Arthralgia
|
5.0%
4/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
8.8%
7/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Nervous system disorders
Fatigue
|
11.2%
9/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
7.5%
6/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
General disorders
Hot Flashes
|
15.0%
12/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
3.8%
3/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Musculoskeletal and connective tissue disorders
Joint Function
|
11.2%
9/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
12.5%
10/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
20.0%
16/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
7.5%
6/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
3/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
6.2%
5/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Nervous system disorders
Pain - Back
|
5.0%
4/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
3.8%
3/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Nervous system disorders
Pain - Hip
|
6.2%
5/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
1.2%
1/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
|
Nervous system disorders
Pain - Shoulder
|
6.2%
5/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
0.00%
0/80 • 1 year, 9 months
Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place