Prevention of Osteoporosis in Breast Cancer Survivors

NCT00567606 | Completed DMC

• 2 other identifiers: 0536-01-FB1R01NR007743-04
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 4

Brief Summary

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

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  Bone Mineral Density (gm/cm2) will be measured by Dual-Energy X-ray Absorptiometry (DEXA) of the hip, spine and forearm

  at 12, 24, and 36 months

Secondary Outcomes (1)

• Muscle Strength

  at baseline, 6, 12, 24, and 36 months

Study Arms (2)

Strength/Weight Training

EXPERIMENTAL

Subjects in the G1 group receive drug/supplement combination and strength/weight training exercises for upper and lower extremities and the spine.

Other: Strength/Weight Training & Drug/Supplement

Drug Supplement only

EXPERIMENTAL

Subjects in the G2 group receive drug/supplement combination, but do not participate in strength/weight training exercises.

Combination Product: Drug/Supplement only

Interventions

Strength/Weight Training & Drug/Supplement OTHER

G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine.

Also known as: Actonel

Strength/Weight Training

Drug/Supplement only COMBINATION_PRODUCT

G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises.

Also known as: Actonel

Drug Supplement only

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (4)

University of Nebraska Medical Center, College of Nursing

Kearney, Nebraska, 68849-4510, United States

Location

University of Nebraska Medical Center, College of Nursing

Lincoln, Nebraska, 68588-0220, United States

Location

University of Nebraska Medical Center, College of Nursing

Omaha, Nebraska, 68198-5330, United States

Location

University of Nebraska Medical Center, College of Nursing

Scottsbluff, Nebraska, 69361-4939, United States

Location

Related Publications (2)

• Twiss 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 RESULT

• Ott 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 RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nancy L Waltman, PhD, ARNP

  University of Nebraska Medical Center, College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: April 1, 2002
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (4)