Breast NeoplasmsPhase 2NCT00904033

Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

A Phase 2 study testing Calcitriol, Exercise and Multivitamin in people with Breast Neoplasms and Bone and Bones, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasms, Bone and Bones
What is being tested?: Calcitriol, Exercise and Multivitamin
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2008to 1 Jan 2018
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

Must be female.
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.
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.
Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.
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 12-week supplementation of calcitriol 45 μg. Participants assigned to either of the calcitriol treatment arms will be instructed to stop taking calcium and/or vitamin D supplements.
Must be less than five years from the diagnosis of breast cancer and have received chemotherapy, radiation therapy, and/or hormonal therapy. Chemotherapy and radiation therapy, if received, must have been completed prior to study enrollment. Hormonal therapy may be ongoing.

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 > 10.2 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.

Show all 15Show fewer

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.
Previously verified diagnosed of osteoporosis.
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 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Medical Center
Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Pilot Study of the Effects of High-Dose Oral Calcitriol and Physical Activity on Bone Health in Breast Cancer Survivors

Both the calcitriol and exercise interventions are aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients and survivors. The combination of calcitriol and exercise, which function through different but similar mechanisms, could produce interactive effects in reducing fracture risk among breast cancer survivors.

Hypothesis: A combination of calcitriol along with a structured home-based walking and progressive resistance exercise program will be efficacious in preventing bone resorption and in increasing bone formation among survivors of invasive breast cancer.

Read the detailed description

Primary Objective

To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for improving bone health among breast cancer survivors.

Secondary Objectives

Conditions: Breast Neoplasms, Bone and Bones
Being tested: Calcitriol, Exercise, Multivitamin
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CalcitriolDrug
Calcitriol tablet taken once per week.
ExerciseBehavioural
Exercise consisting of progressive walking and resistance band training
MultivitaminDietary supplement
Also called Control

Study groups in NCT00904033
Study group	Role	What they receive
Multivitamin	Active comparator	Multivitamin used as control group. Receives: Dietary Supplement: Multivitamin
Exercise	Experimental	Exercise consisting of progressive walking and resistance band training. Receives: Behavioral: Exercise
Calcitriol	Experimental	Calcitriol pill taken once per week. Receives: Drug: Calcitriol
Calcitriol and Exercise	Experimental	Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training. Receives: Drug: Calcitriol; Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Bone Resorption (Exercise)
Bone Resorption using Serum NTx (Exercise comparison)
Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE).
Measured: Week 12
Bone Resorption (Calcitriol)
Bone Resorption using Serum NTx (Calcitriol comparison)
Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE).
Measured: Week 12
Bone Formation (Exercise)
Bone Formation using Serum BSAP (Exercise comparison)
The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies.
Measured: Week 12
Bone Formation (Calcitriol)
Bone Formation using Serum BSAP (Calcitriol comparison)
The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies.
Measured: Week 12

Secondary outcomes (4)

Handgrip (kg) Strength - (Exercise)
Handgrip (kg) Strength (Exercise comparison)
Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength.
Measured: Week 12
Handgrip (kg) Strength - (Calcitriol)
Handgrip (kg) Strength - (Calcitriol comparison)
Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength.
Measured: Week 12
Body Mass Index (Exercise)
Body Mass Index (BMI) - (Exercise Comparison)
Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese".
Measured: Week 12
Body Mass Index (Calcitriol)
Body Mass Index(BMI) - (Calcitriol comparison)
Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese".
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20081 Jan 2018

First posted19 May 2009 (estimated)
Study start1 Dec 2008
Primary completion1 Jan 2018
Study completion1 Jan 2018

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 Breast NeoplasmsStudies 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: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00904033
Sponsor's protocol ID: RSRB00025478
Status last verified: Apr 2019
First submitted: 15 May 2009
Last updated: 23 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of the Effects of High-Dose Oral Calcitriol and Physical Activity on Bone Health in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT00904033
Acronym / sponsor ID: RSRB00025478
Conditions: Breast Neoplasms, Bone and Bones
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: 1 Dec 2008 (actual)
Primary completion: 1 Jan 2018 (actual)
Study completion: 1 Jan 2018 (actual)
First posted: 19 May 2009 (estimated)
Results: Posted 23 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective

Secondary Objectives

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Multivitamin	Active comparator	Dietary Supplement: MultivitaminMultivitamin used as control group.
Exercise	Experimental	Behavioral: ExerciseExercise consisting of progressive walking and resistance band training.
Calcitriol	Experimental	Drug: CalcitriolCalcitriol pill taken once per week.
Calcitriol and Exercise	Experimental	Drug: Calcitriol, Behavioral: ExerciseCalcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Must be female.
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.
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.

Key exclusion criteria (15 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 > 10.2 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
CalcitriolCalcitriol tablet taken once per week.	Drug	Calcitriol, Calcitriol and Exercise
ExerciseExercise consisting of progressive walking and resistance band training	Behavioural	Calcitriol and Exercise, Exercise
MultivitaminAlso: Control	Dietary supplement	Multivitamin

Primary outcome

Bone Resorption (Exercise)
Time frame: Week 12
Bone Resorption using Serum NTx (Exercise comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE).
Bone Resorption (Calcitriol)
Time frame: Week 12
Bone Resorption using Serum NTx (Calcitriol comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE).
Bone Formation (Exercise)
Time frame: Week 12
Bone Formation using Serum BSAP (Exercise comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies.
Bone Formation (Calcitriol)
Time frame: Week 12
Bone Formation using Serum BSAP (Calcitriol comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies.

4 secondary outcomes

Handgrip (kg) Strength - (Exercise)
Time frame: Week 12
Handgrip (kg) Strength - (Calcitriol)
Time frame: Week 12
Body Mass Index (Exercise)
Time frame: Week 12
Body Mass Index (Calcitriol)
Time frame: Week 12

Results and safety

Results posted to the registry on 23 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multivitamin	10	9
Exericse	10	9
Calcitriol	10	9
Calcitriol and Exercise	11	9

Primary outcome: Bone Resorption (Exercise)

Time frame: Week 12. Least squares mean (Standard Error). Unit: nm BCE

Measure	No Exercise n = 20	Exercise n = 19
Value	13.8 (1.656)	14.7 (1.033)

No Exercise vs Exercise: p = 0.86, ANCOVA

Population analysed: No Exercise group consists of Multivitamin and Calcitriol arms N=20; Exercise group consists of Exercise and Calcitriol+Exercise arms N=19\*\* \*\* 2 subjects have missing data for this outcome.

Primary outcome: Bone Resorption (Calcitriol)

Time frame: Week 12. Least squares mean (Standard Error). Unit: nm BCE

Measure	No Calcitriol n = 20	Calcitriol n = 19
Value	12.5 (1.785)	15.0 (1.113)

No Calcitriol vs Calcitriol: p = 0.19, ANCOVA

Population analysed: No Calcitriol group consists of Multivitamin arm and Exercise arm N=20; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=19\*\* \*\* 2 subjects have missing data for this outcome.

Primary outcome: Bone Formation (Exercise)

Time frame: Week 12. Least squares mean (Standard Error). Unit: ng/ml

Measure	No Exercise n = 20	Exercise n = 20
Value	13.8 (1.513)	14.7 (0.957)

No Exercise vs Exercise: p = 0.49, ANCOVA

Population analysed: No Exercise group consists of Multivitamin and Calcitriol arms N=20; Exercise group consists of Exercise and Calcitriol+Exercise arms N=20\*\* \*\*1 subject has missing data for this outcome.

Primary outcome: Bone Formation (Calcitriol)

Time frame: Week 12. Least squares mean (Standard Error). Unit: ng/ml

Measure	No Calcitriol n = 20	Calcitriol n = 20
Value	12.0 (1.268)	16.3 (0.802)

No Calcitriol vs Calcitriol: p <0.01, ANCOVA

Population analysed: No Calcitriol group consists of Multivitamin arm and Exercise arm N=20; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=20\*\* \*\* 1 subject has missing data for this outcome.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multivitamin	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Exericse	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Calcitriol	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Calcitriol and Exercise	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
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, Ph.D. 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 Calcitriol, Exercise and Multivitamin in people with Breast Neoplasms and Bone and Bones, 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 8 inclusion and 15 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 23 Apr 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 23 Apr 2019). 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?

Bone Resorption (Exercise) (time frame: Week 12). The study lists 4 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 NCT00904033.

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 23 Apr 2019.