Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy

NCT00485953 | Completed Phase 4 Results DMC

• 1 other identifier: PRO06080002 (REBBeCA II)
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly, postmenopausal women with breast cancer on aromatase inhibitors are at increased risk of developing bone loss and osteoporosis. We postulate that in elderly, osteopenic postmenopausal women who are on aromatase inhibitor therapy, bisphosphonate therapy will (1) prevent bone loss at clinically relevant sites, such as the spine and hip and (2) decrease bone turnover.

Conditions

Bone Loss; Osteoporosis; Breast Cancer

Keywords

Osteoporosis; breast cancer; aromatase inhibitors; bone loss; bone mineral density

Outcome Measures

Primary Outcomes (1)

• BMD of Spine by DXA

  BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.

  at 24 months

Secondary Outcomes (2)

• BMD by DXA at the Femoral Neck and Total Hip

  at 24 months

• Markers of Bone Resorption and Bone Formation

  at 24 months

Study Arms (2)

Active Medication Group

EXPERIMENTAL

risedronate 35 mg weekly

Drug: risedronate

Placebo Group

NO INTERVENTION

Placebo

Interventions

risedronate DRUG

risedronate 35 mg per week

Also known as: Actonel

Active Medication Group

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elderly postmenopausal women (ages 55 and older)
• osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.
• with breast cancer on aromatase inhibitor therapy
• with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)
• type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients
• Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits

You may not qualify if:

• Women with stage 4 breast cancer (presence of distant metastases)
• Women with normal bone density by DXA (T-score \> -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.
• Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR \<30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.
• Women being treated with oral glucocorticoid therapy \>3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).
• Those with untreated active peptic ulcer disease
• Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.
• Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)
• Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor
• Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study
• Use of fluoride for more than 1 month ever (except for dental treatment)
• Less than 2 evaluable vertebrae
• Distant metastatic disease

Sponsors & Collaborators

• Susan L. Greenspan: lead
• University of Pittsburgh: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 38979716 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Breast Neoplasms

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Susan Greenspan
• Organization: University of Pittsburgh

greenspn@pitt.edu

412-692-2476

Study Officials

• Susan L. Greenspan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 13, 2017
• Results First Posted: July 3, 2014

Record last verified: 2017-09

Locations

US (1)