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Breast CancerPhase 3NCT00324714

Risedronate in Improving Bone Mineral Density and Bone Health in Postmenopausal Women With Ductal Carcinoma In Situ Enrolled in Clinical Trial CRUK-IBIS-II-DCIS

A Phase 3 study testing risedronate sodium and diagnostic laboratory biomarker analysis in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation at 2 sites in Switzerland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in improving bone mineral density and bone health in women with ductal carcinoma in situ. Read more about this study

Who is it for?
Ages 40 to 70 years, women only
Conditions the study is for
Breast Cancer, Osteoporosis
What is being tested?
risedronate sodium and diagnostic laboratory biomarker analysis
How many people
0 participants
Where
2 sitesSwitzerland
Study dates
Feb 2003to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of ductal carcinoma in situ within the past 6 months
  • Locally excised with tumor-free margins at least 1 mm
  • Currently enrolled in protocol CRUK-IBIS-II-DCIS AND randomized to receive either anastrozole or placebo
  • No T-score < -4.0 and/or > 2 low trauma vertebral fractures by dual-energy x-ray absorptiometry (DXA)
  • Hormone receptor status: Estrogen or progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

  • Female patient
  • Postmenopausal
  • No prior bilateral hip fracture or bilateral hip prostheses
  • No concurrent metabolic bone disease, including any of the following:
  • Paget's disease
  • Osteogenesis imperfecta
  • Disorders of calcium or mineral metabolism
  • Renal calculus
  • Malabsorption
  • Hypercalcemia or hypocalcemia
  • Hyperparathyroidism or hypoparathyroidism
  • Hyperthyroidism or hypothyroidism
  • Patients on stable replacement therapy are allowed provided they are euthyroid

PRIOR CONCURRENT THERAPY:

  • More than 12 months since prior medication affecting bone metabolism, including any of the following:
  • Estrogen
  • Any bisphosphonate
  • Parathyroid hormone
  • Calcitonin
  • Oral or systemic glucocorticoids

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Inselspital Bern

    Bern, CH-3010

  • Oncocare Sonnenhof-Klinik Engeriedspital

    Bern, CH-3012

Other trials in Switzerland

About this study

Official title: A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Bone Biomarkers of Anastrozole When Used to Prevent Breast Cancer in Postmenopausal Women

RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in improving bone mineral density and bone health in women with ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying risedronate to see how well it works compared to a placebo in improving bone mineral density and bone health in postmenopausal women with ductal carcinoma in situ enrolled in clinical trial CRUK-IBIS-II-DCIS (CRUK: Cancer Research UK) (DCIS: Ductal carcinoma in situ).

Read the detailed description

OBJECTIVES:

Primary

  • Compare the changes in bone of the spine and femur in postmenopausal women with ductal carcinoma in situ treated with anastrozole vs placebo on protocol CRUK-IBIS-II-DCIS.
  • Determine the effect of bisphosphonate treatment on bone mineral density and bone metabolism in patients who are receiving anastrozole on protocol CRUK-IBIS-II-DCIS and are osteoporotic or moderately to severely osteopenic at baseline.

Secondary

  • Correlate changes in levels of biochemical markers of bone metabolism with longer-term changes in bone mineral density, as measured by dual-energy x-ray absorptiometry (DXA).

OUTLINE: This is a multicenter, partially randomized, double-blind study. Patients are stratified according to bone mineral density (T-score) measurements (≥ -1.5 vs -2.5 to < -1.5 vs -4.0 to < -2.5 or ≤ 2 low-trauma vertebral fractures). Patients in stratum I are further stratified according to calcium and cholecalciferol (vitamin D) supplementation (yes vs no) and use of risedronate on this study (yes vs no). Patients in stratum II are further stratified according to randomized treatment on protocol CRUK-IBIS-II-DCIS (yes vs no).

  • Stratum I (T-score ≥ -1.5): Patients undergo dual-energy x-ray absorptiometry (DXA) scanning at baseline and then at 1, 3, 5, and 7 years. Patients who develop osteoporosis (T-score < -2.5) are removed from the study and receive open-label bisphosphonates.
  • Stratum II (T-score -2.5 to < -1.5 [moderate to severe osteopenia]): Patients undergo DXA scanning as in stratum I. Patients are also randomized (double-blind) to 1 of 2 treatment arms.
  • Arm I: Patients receive oral risedronate once a week for 5 years.
  • Arm II: Patients receive oral placebo once a week for 5 years. Patients in either arm who develop osteoporosis AND a drop in T-score of more than 1 unit are removed from the study and receive open-label bisphosphonates.
  • Stratum III (T-score -4.0 to < -2.5 OR ≤ 2 low trauma vertebral fractures [osteoporosis]): Patients undergo DXA scanning as in stratum I. Patients also receive oral risedronate (or their current bisphosphonate) once a week for 5 years.

Blood samples for correlative studies (e.g., bone biomarkers, serum estradiol) are collected at baseline and at 6 and 12 months.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Being tested
risedronate sodium, diagnostic laboratory biomarker analysis
Keywords
osteoporosis, ductal breast carcinoma in situ, breast cancer in situ
Medical subject headings
Breast Neoplasms, Osteoporosis, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • risedronate sodiumDrug

  • diagnostic laboratory biomarker analysisOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spine and femur bone change comparison

  2. Effects of bisphosphonate on bone mineral density and bone metabolism in patients who were osteoporotic or moderately severe osteopenic at baseline

Secondary outcomes (1)

  1. Correlation of changes in levels of biochemical markers of bone metabolism with longer-term changes in bone mineral density as measured by dual-energy x-ray absorptiometry (DXA)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2006 (estimated)
  2. Study startFeb 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324714
Sponsor's protocol ID
CDR0000474949
Other IDs
IBCSG-31-03-PBS, EUDRACT-2004-003991-12
Status last verified
Nov 2012
First submitted
10 May 2006
Last updated
29 Nov 2012
Results posted
No

Publications

  • Singh S, Cuzick J, Edwards R, et al.: Effect of anastrozole on bone mineral density after one year of treatment: results from bone sub-study of the International Breast Cancer Intervention Study (IBIS-II). [Abstract] Breast Cancer Res Treat 106 (1): A-28, S9, 2007.

  • Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

    PubMed 38979716

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risedronate sodium and diagnostic laboratory biomarker analysis in people with Breast Cancer and Osteoporosis, run by ETOP IBCSG Partners Foundation at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spine and femur bone change comparison. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00324714, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.

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