Phase 2
N=41
Calcitriol, Physical Activity, and Bone Health in Cancer Survivors
Breast Neoplasms · Bone and Bones
Bottom Line
View on ClinicalTrials.gov: NCT00904033 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Bone Resorption (Exercise) — 13.8; 14.7 nm BCE — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Calcitriol (Drug); Exercise (Behavioral); Multivitamin (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Resorption (Exercise) |
13.8; 14.7 | 0.86 |
| PRIMARY Bone Resorption (Calcitriol) |
12.5; 15.0 | 0.19 |
| PRIMARY Bone Formation (Exercise) |
13.8; 14.7 | 0.49 |
| PRIMARY Bone Formation (Calcitriol) |
12.0; 16.3 | <0.01 sig |
| SECONDARY Handgrip (kg) Strength - (Exercise) |
26.6; 27.8 | 0.16 |
| SECONDARY Handgrip (kg) Strength - (Calcitriol) |
27.4; 27.1 | 0.84 |
| SECONDARY Body Mass Index (Exercise) |
30.0; 30.2 | 0.38 |
| SECONDARY Body Mass Index (Calcitriol) |
30.1; 30.1 | 0.92 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 10.2 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00904033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.