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A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma

Phase 3
18 Years
Not Enrolling
Breast Cancer, Osteoporosis

Thank you

Trial Information

A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma


- Compare the effectiveness of risedronate vs placebo in the prevention of bone loss in
premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast

- Compare the degree of bone loss over 1 year in these women according to menopausal
status after 1 year of therapy.

- Determine the relationship of current climacteric symptoms, menstrual and reproductive
history, and chemotherapy regimen with ovarian failure (permanent cessation of menses)
in these women.

- Determine the relationship of baseline serum estradiol levels with ovarian failure in
these women.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are
stratified according to planned tamoxifen therapy (yes vs no vs undecided), planned taxane
therapy (yes vs no vs undecided), time from last menses (1-3 months vs longer than 3 months
to 6 months), and age (under 40 vs 40 to 49 vs 50 and over). Patients are randomized to 1 of
2 treatment arms.

- Arm I: Patients receive oral calcium and oral cholecalciferol daily and oral
risedronate once weekly.

- Arm II: Patients receive calcium and cholecalciferol as in arm I and oral placebo once

In both arms, treatment begins during the first month of chemotherapy and continues for 1
year in the absence of unacceptable toxicity.

Questionnaires about cessation of menses, ovarian failure, and menopausal symptoms are
completed at baseline, monthly during chemotherapy, at 6 months, and then at 1 and 2 years.

Patients are followed for 1 year.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this
study within 11 months.

Inclusion Criteria


- Resectable primary breast cancer

- Stage I-IIIB disease

- Scheduled to undergo adjuvant or neoadjuvant chemotherapy

- No hypercalcemia (calcium level greater than 1 mg/dL above upper limit of normal
within the past 6 months)

- No hypocalcemia (calcium level greater than 0.5 mg/dL below lower limit of normal
within the past 6 months)

- No diseases affecting bone metabolism (i.e., hyperparathyroidism, hyperthyroidism,
and hypercortisolism)

- Bone mineral density T score of -2.0 or greater at the hip or spine (T score of -2.1
or less is ineligible)



- 18 and over


- Female

Menopausal status

- Premenopausal meeting the following criteria:

- No more than 6 months since last menstrual period

- No prior bilateral oophorectomy

- Not on estrogen replacement therapy

- If total abdominal hysterectomy performed, then must have at least 1 intact

- If more than 3 months since last menstrual period, then must have
premenopausal estrogen levels within 1 month of study entry

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Not specified


- Not specified


- Creatinine no greater than 2.0 mg/dL

- No history of severe renal impairment


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- Able to stand or sit upright for at least 30 minutes

- No known swallowing disorder

- No history of vertebral compression fracture

- Traumatic fracture of the coccyx allowed

- No malabsorption syndrome


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- No concurrent estrogen

- No concurrent estrogen receptor modulators except tamoxifen

- No corticosteroid dose of prednisone or equivalent greater than 5 mg daily for more
than 2 weeks within the past 6 months

- No concurrent estrogen replacement therapy

- No concurrent oral contraceptives


- Not specified


- More than 3 months since prior and no concurrent dental extraction, root canal, or
dental implants

- No prior bilateral oophorectomy


- No prior bisphosphonates

- No other concurrent bisphosphonates

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry

Principal Investigator

Stephanie Hines, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms
  • Osteoporosis



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