Bone Metabolism BiomarkersPhase 2NCT01419730
Vitamin D and Physical Activity on Bone Health
A Phase 2 study testing Vitamin D3 and Physical Activity in people with Bone Metabolism Biomarkers and Bone Mineral Density, run by University of Rochester at 1 site in United States.
Trial summary
This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and without physical activity (walking and progressive resistance exercise), in treating bone loss in women who have undergone treatment for… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Bone Metabolism Biomarkers, Bone Mineral Density, Physical Fitness
- What is being tested?
- Vitamin D3 and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 30 Dec 2026
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be female and have a primary diagnosis of Stage I, II, or III hormone-receptor positive breast cancer.
- Women must be postmenopausal at time of enrollment.
- Must provide informed consent.
- Must be willing to discontinue use of calcium and/or vitamin D supplements.
- Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.6 mg/dl.
- Participants must be slightly vitamin D deficient (serum vitamin D level <32ng/ml)
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- Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.132
- Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 24-week supplementation of vitamin D.
- Must be less than five years from the diagnosis of breast cancer and must be within 12 months of starting treatment with aromatase inhibitors (AI) in accordance with American Society of Clinical Oncology (ASCO) guidelines.
Who cannot join
- 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 who had a myocardial infarction within the past year.
- Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
- 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 ≥ 10.6 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
- Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.
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- 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 vitamin D.
- Patients who are severely vitamin D deficient (<10 ng/ml).
- Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
- Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy
This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and without physical activity (walking and progressive resistance exercise), in treating bone loss in women who have undergone treatment for breast cancer. The investigators would also like to find out if the physical activity program improves cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and balance. One hundred five (105) 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.
- Being tested
- Vitamin D3, Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Vitamin D3 50,000 IU
Physical ActivityBehavioural
Progressive walking and resistance band exercise prescription for a period of 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 50,000 IU | Active comparator | Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks. Receives: Drug: Vitamin D3 |
| Vitamin D3 50,000 IU and Physical Activity | Active comparator | Vitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks. Receives: Drug: Vitamin D3; Behavioral: Physical Activity |
| Control | No intervention | Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the Amount of Bone Mineral Density Loss in Non-metastatic Breast Cancer Patients Receiving a High Dose Vitamin D Therapy Along With a Structured Home-based Walking and Progressive Resistance Exercise Program.
To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months. Amount of bone loss was measured with change in BMD.
Measured: 24 weeks
Secondary outcomes (3)
Measure the Effect of Vitamin D and Muscle Strength in Non-metastatic Breast Cancer Patients
Measuring physical fitness for muscle strength using handgrip dynamometer in non-metastatic breast cancer patients who begin hormonal therapy within the previous 12 months.
Measured: 24 weeks
Measure the Effect of Vitamin D and Aerobic Capacity in Non-metastatic Breast Cancer Patients
Pedometer for number of steps for aerobic capacity.
Measured: 24 Weeks
Measure the Effect of Vitamin D and Balance in Non-metastatic Breast Cancer Patients
Testing Force Plate Area95 Eyes Closed Open Base for measure of balance
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion30 Dec 2024
- Study completion30 Dec 2026 (estimated)
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.
- Other trials for Bone Metabolism BiomarkersStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Peppone, University of Rochester
- Investigators
- Luke J Peppone, PhD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419730
- Sponsor's protocol ID
- 34834
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2011
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy
- ClinicalTrials.gov ID
- NCT01419730
- Acronym / sponsor ID
- 34834
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 191 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 5 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and without physical activity (walking and progressive resistance exercise), in treating bone loss in women who have undergone treatment for breast cancer. The investigators would also like to find out if the physical activity program improves cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and balance. One hundred five (105) 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 50,000 IU | Active comparator | Drug: Vitamin D3Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks. |
| Vitamin D3 50,000 IU and Physical Activity | Active comparator | Drug: Vitamin D3, Behavioral: Physical ActivityVitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks. |
| Control | No intervention | –Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be female and have a primary diagnosis of Stage I, II, or III hormone-receptor positive breast cancer.
- Women must be postmenopausal at time of enrollment.
- Must provide informed consent.
- Must be willing to discontinue use of calcium and/or vitamin D supplements.
- Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.6 mg/dl.
Key exclusion criteria (12 listed)
- 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 who had a myocardial infarction within the past year.
- Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
- 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 ≥ 10.6 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
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 D3Vitamin D3 50,000 IU | Drug | Vitamin D3 50,000 IU, Vitamin D3 50,000 IU and Physical Activity |
| Physical ActivityProgressive walking and resistance band exercise prescription for a period of 24 weeks | Behavioural | Vitamin D3 50,000 IU and Physical Activity |
Primary outcome
Measure the Amount of Bone Mineral Density Loss in Non-metastatic Breast Cancer Patients Receiving a High Dose Vitamin D Therapy Along With a Structured Home-based Walking and Progressive Resistance Exercise Program.
Time frame: 24 weeks
To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months. Amount of bone loss was measured with change in BMD.
3 secondary outcomes
Measure the Effect of Vitamin D and Muscle Strength in Non-metastatic Breast Cancer Patients
Time frame: 24 weeks
Measure the Effect of Vitamin D and Aerobic Capacity in Non-metastatic Breast Cancer Patients
Time frame: 24 Weeks
Measure the Effect of Vitamin D and Balance in Non-metastatic Breast Cancer Patients
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Luke J Peppone, PhD, MPH principal investigator
University of Rochester
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 and Physical Activity in people with Bone Metabolism Biomarkers and Bone Mineral Density, run by University of Rochester 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 9 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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 5 Aug 2026). 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?
Measure the Amount of Bone Mineral Density Loss in Non-metastatic Breast Cancer Patients Receiving a High Dose Vitamin D Therapy Along With a Structured Home-based Walking and Progressive Resistance Exercise Program. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.