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NCT00904033 · ClinicalTrials.gov registry record · Phase 2

Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

A Phase 2 study, sponsored by University of Rochester.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT00904033: Completed Phase 2 study, sponsored by University of Rochester.

NCT00904033 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00904033, a Phase 2 study, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study 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.

Primary Outcome

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 ra

Interventions

  • BEHAVIORAL Exercise
  • DIETARY_SUPPLEMENT Multivitamin
  • DRUG Calcitriol

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2008-12-01
Est. Completion 2018-01-01
Phase Phase 2
University of Rochester

636 total trials

What the finished NCT00904033 record still lists

NCT00904033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 3 interventions - of which Exercise is the first listed.

NCT00904033 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00904033 about?

NCT00904033 is a clinical study titled "Calcitriol, Physical Activity, and Bone Health in 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 amon...

What is the current status of trial NCT00904033?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2008-12-01. Estimated completion is 2018-01-01.

What interventions are being tested in trial NCT00904033?

The interventions under investigation include: Exercise (BEHAVIORAL), Multivitamin (DIETARY_SUPPLEMENT), Calcitriol (DRUG).

Who is sponsoring clinical trial NCT00904033?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00904033's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00904033, the US trial registry maintained by the National Library of Medicine. NCT00904033 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.