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Completed

NCT Number: NCT00859703

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

risedronate

Drug

35mg oral risedronate once per week for 24 months

Placebo

Drug

Placebo 35 mg once a week for 24 months

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Evolution of femoral BMD after one year of treatment

    Time frame: 1 year

  2. Evolution of lumbar spine and femoral BMD after two years of treatment

    Time frame: 2 years

  3. Evolution of bone resorption and formation markers

    Time frame: 2 years

  4. Proportion of fractures after two years of treatment

    Time frame: 2 years

  5. Evolution of estradiol levels

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.

Acronym: RISAROS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2009
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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