Muscle PainPhase 2NCT01509079
Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
A Phase 2 study testing Vitamin D3 in people with Muscle Pain and Joint Pain, run by HealthPartners Institute at 1 site in United States.
Trial summary
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Muscle Pain, Joint Pain
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Women with a history of stage I-IIIa invasive breast cancer
- History of hormone-receptor positive cancer (either ER + or PR + or both)
- Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
- Are experiencing AIMSS
Who cannot join
- Unable to read or understand English
- History of psychiatric disability affecting informed consent or compliance with drug intake
- Malabsorption syndrome or inability to take oral medication
- Has less than 7 months of AI therapy remaining
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Frauenshuh Cancer Center
Minneapolis, Minnesota, 55416
About this study
Official title: Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
Read the detailed description
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.
- Conditions
- Muscle Pain, Joint Pain
- Being tested
- Vitamin D3
- Medical subject headings
- Myalgia, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Cholecalciferol capsule, 4000IU, daily for 6 months
Vitamin D3Drug
cholecalciferol capsule, 600 IU, daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 4000 IU | Experimental | Not described Receives: Drug: Vitamin D3 |
| Vitamin D3 600 IU | Active comparator | Not described Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale
The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia
Measured: baseline to 6 months
Change in Hand Grip Strength
Measured: baseline to 6 months
Secondary outcomes (6)
Change in PROMIS Physical Functioning Questionnaire
PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).
Measured: baseline to 6 months
Average Percent Adherence to Vitamin D Interventio
adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months
Measured: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months
Serum Estradiol Concentrations
Measured: baseline and 6 months
Change in Steady State Concentrations of Serum Anastrazole and Letrozole
Difference in steady state concentrations in plasma from baseline to 6 months
Measured: baseline to 6 months
Whole Body Bone Mineral Density
GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use
Measured: From Baseline and 6 months of D3 supplementation
Vitamin D Binding Protein Genotype
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Alice C. Shapiro, PhD RD, Principal investigator, Park Nicollet Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509079
- Sponsor's protocol ID
- 03962-10C
- Status last verified
- Oct 2015
- First submitted
- 12 Dec 2011
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shapiro AC, Adlis SA, Robien K, Kirstein MN, Liang S, Richter SA, Lerner RE. Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast Cancer Res Treat. 2016 Feb;155(3):501-12. doi: 10.1007/s10549-016-3710-6. Epub 2016 Feb 11.
PubMed 26868123
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT01509079
- Acronym / sponsor ID
- 03962-10C
- Conditions
- Muscle Pain, Joint Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota, University of Southern California
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Posted 29 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
Detailed description
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 4000 IU | Experimental | Drug: Vitamin D3 |
| Vitamin D3 600 IU | Active comparator | Drug: Vitamin D3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Women with a history of stage I-IIIa invasive breast cancer
- History of hormone-receptor positive cancer (either ER + or PR + or both)
- Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
- Are experiencing AIMSS
Key exclusion criteria (4 listed)
- Unable to read or understand English
- History of psychiatric disability affecting informed consent or compliance with drug intake
- Malabsorption syndrome or inability to take oral medication
- Has less than 7 months of AI therapy remaining
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Cholecalciferol capsule, 4000IU, daily for 6 months | Drug | Vitamin D3 4000 IU |
| Vitamin D3cholecalciferol capsule, 600 IU, daily for 6 months | Drug | Vitamin D3 600 IU |
Primary outcome
Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale
Time frame: baseline to 6 months
The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia
Change in Hand Grip Strength
Time frame: baseline to 6 months
6 secondary outcomes
Change in PROMIS Physical Functioning Questionnaire
Time frame: baseline to 6 months
Average Percent Adherence to Vitamin D Interventio
Time frame: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months
Serum Estradiol Concentrations
Time frame: baseline and 6 months
Change in Steady State Concentrations of Serum Anastrazole and Letrozole
Time frame: baseline to 6 months
Whole Body Bone Mineral Density
Time frame: From Baseline and 6 months of D3 supplementation
Vitamin D Binding Protein Genotype
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26868123Shapiro AC, Adlis SA, Robien K, Kirstein MN, Liang S, Richter SA, Lerner RE. Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast Cancer Res Treat. 2016 Feb;155(3):501-12. doi: 10.1007/s10549-016-3710-6. Epub 2016 Feb 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice C. Shapiro, PhD RD principal investigator
Park Nicollet Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Muscle Pain and Joint Pain, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale (time frame: baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.