Clinical trial · Interventional
Prevention of Osteoporosis in Breast Cancer Survivors
NCT00567606CI-TRIAL-00071829completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test whether strength/weight training exercises enhance the effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of osteoporosis in postmenopausal breast cancer survivors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postmenopausal Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug/Supplement only | Combination Product | — | UNRESOLVED |
| Strength/Weight Training & Drug/Supplement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Strength/Weight Training
- description
- Subjects in the G1 group receive drug/supplement combination and strength/weight training exercises for upper and lower extremities and the spine.
- interventionNames
- Other: Strength/Weight Training & Drug/Supplement
- type
- EXPERIMENTAL
- label
- Drug Supplement only
- description
- Subjects in the G2 group receive drug/supplement combination, but do not participate in strength/weight training exercises.
- interventionNames
- Combination Product: Drug/Supplement only
Primary outcomes (1)
- measure
- Bone Mineral Density
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * read, speak and understand English; * be female; * be between the ages of 35 and 75; * have completed treatment (except tamoxifen) for stage 0, I or II breast cancer (i.e. surgery, chemotherapy, radiation) at least 6 months prior to admission to the study; * be 1 year postmenopausal (12-months amenorrheic; subjects 55-years or younger with history of hysterectomy without oophorectomy must have it confirmed by two baseline measures of FSH \>40 IU/ml); * have a BMD T-score of -1.0 SD or lower at one or more sites (spine, hip or forearm); and * have agreement of their primary care provider for participation in the study. Exclusion Criteria: * have a recurrence of their breast cancer; * currently take hormone replacement therapy, bisphosphonates, calcitonin, raloxifene, calcitriol, or glucocorticosteroids.; * currently do strength/weight training exercises or high impact exercises (such as running, jumping rope, high impact aerobic dance, martial arts, volleyball, or basketball) two to three times weekly; * have a body mass index (BMI) equal to or greater than 35; * have serum calcium, creatinine or TSH (if on thyroid therapy) outside the normal limits; * have active gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis, or ulcers; * have Paget=s disease; * have renal disease (renal stones or serum creatinine levels greater than the upper normal limits); * have a recent history of a spinal fracture (within the past 6 months); * have features of an acute fracture on baseline spinal x-rays; * have other concomitant conditions that prohibit strength/weight training exercises, calcium, or vitamin D intake.
References
Publications (2)
- RESULTTwiss JJ, Gross GJ, Waltman NL, Ott CD, Lindsey AM. Health behaviors in breast cancer survivors experiencing bone loss. J Am Acad Nurse Pract. 2006 Oct;18(10):471-81. doi: 10.1111/j.1745-7599.2006.00165.x. PMID 16999712
- RESULTOtt CD, Twiss JJ, Waltman NL, Gross GJ, Lindsey AM. Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention. Cancer Nurs. 2006 Jan-Feb;29(1):21-31, quiz 32-3. doi: 10.1097/00002820-200601000-00004. PMID 16557117