Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer

NCT00859703 | Completed Phase 3

• 1 other identifier: 2006.45346
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures. This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer

Conditions

Breast Cancer; Menopause; Osteopenia

Keywords

Aromatase inhibitor treatment; osteoporosis; breast cancer; bisphosphonates

Outcome Measures

Primary Outcomes (1)

• Evolution of the lumbar spine Bone Mineral Density after one year of treatment

  1 year

Secondary Outcomes (5)

• Evolution of femoral BMD after one year of treatment

  1 year

• Evolution of lumbar spine and femoral BMD after two years of treatment

  2 years

• Evolution of bone resorption and formation markers

  2 years

• Proportion of fractures after two years of treatment

  2 years

• Evolution of estradiol levels

  2 years

Study Arms (2)

2

PLACEBO COMPARATOR

Patients receive placebo 35 mg once a week plus a calcium and vitamin D supplementation. Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment

Drug: Placebo

1

ACTIVE COMPARATOR

Patients receive risedronate 35 mg once a week plus a calcium and vitamin D supplementation. Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment

Drug: Risedronate

Interventions

Risedronate DRUG

35mg oral risedronate once per week for 24 months

1

Placebo DRUG

Placebo 35 mg once a week for 24 months

2

Eligibility Criteria

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

You may qualify if:

• Postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means)
• Operated for an invasive breast cancer (histologically proven)
• Surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed
• Treated with aromatase inhibitor
• Osteopenic (-2.5\<T score\<-1) without osteoporotic fracture
• With written informed consent signed
• With social security

You may not qualify if:

• Women presenting a history of osteoporotic fracture or a T score less than -2.5 at at least one measure site
• Women presenting clinical signs of metastases
• Having received other hormonal treatment in the last 3 months
• Having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year
• Presenting a known and untreated hyperthyroid
• Presenting a known hyperadrenocorticism
• Patients treated and followed for Paget's disease of bone
• Presenting a untreated primary hyperparathyroid
• Presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min)
• Patients presenting malabsorption syndrome for glucose/galactose
• Person participating in another clinical trial concerning a medicine susceptible to influence bone mass

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot

Lyon, 69437, France

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

Breast Neoplasms; Bone Diseases, Metabolic; Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; 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

• Aurélie Fontana, M.D

  Hôpital Edouard Herriot

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

FR (1)