ANZ 02P2 / International Breast cancer Intervention Study: IBIS-II Bone Sub-Protocol

Phase 3

Completed

• Conditions: Increased breast cancer risk; Osteoporosis; Osteopenia; Bone fractures; Cancer - Breast; Musculoskeletal - Osteoporosis; Other - Fractures

• Registration Number: ACTRN12605000222640
• Lead Sponsor: Australia and New Zealand Breast Cancer Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Women meeting the entry criteria of the IBIS-II (Prevention) trial will be offered entry into the bone sub-protocol. Women will be selected from the first women randomised into the main trial, and will be enrolled for the sub-protocol subject to: (1) giving informed consent; (2) not being excluded by one or more of the exclusion criteria listed below. Women with T-scores < -2.5 and > -4.0 or 1-2 low trauma vertebral fractures must be treated with risedronate.

Exclusion Criteria

criteria: 1. Women with previous bilateral hip fractures or bilateral hip prostheses. This is because reliable DXA scans cannot be performed.2. Women currently with any type of metabolic bone disease including: Paget's disease, osteogenesis imperfecta, disorders of calcium or mineral metabolism, renal calculus, malabsorption, hyper- or hypocalcaemia, hyper- or hypoparathyroidism, hyper- or hypothyroidism (NB: women on stable thyroid replacement therapy can be included provided they are euthyroid as judged by the investigator). Women with previous conditions that have been corrected are eligible.3. Women who have regularly taken any medication affecting bone metabolism within the past 12 months including oestrogen, any bisphosphonate, parathyroid hormone, calcitonin, oral or systemic glucocorticoid.However, women who have been diagnosed as osteoporotic and are currently taking oral bisphosphonate can join stratum III of the bone sub-study providing their T-score is <-2.5 at the time of randomisation (DXA scan done within 3 months of joining the study).4. Women who have a T score less than -4 and/or more than 2 low trauma vertebral fractures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified