None listed
Conditions
Brief summary
Phase 3 This sub-study is assessing the effects of the drug anastrozole on bone mineral density and other indicators on bone strength, when this drug is used to prevent breast cancer in postmenopausal women. This is an ANZ02P2/International Breast cancer Intervention Study: IBIS II Bone Sub-Protocol. Who is it for? You can join this trial if: You are joining the ANZ02P2 International Breast cancer Intervention Study: IBIS II (Prevention).You must not have not previously have had bilateral hip fractures or bilateral hip prostheses. You must not have a metabolic bone disease. You can not have regularly taken any medication affecting bone metabolism within the past 12 months unless you have been diagnosed as osteoporotic and are currently taking oral bisphosphonate (a bone strengthening drug). Trial details Participants will be divided into three groups based on the results of their baseline bone mineral density scans. Group 1 will comprise of participants with normal bone density. It will be recommended that these participants take calcium and vitamin D supplements. Group 2 will comprise of participants with osteopaenia (or reduced bone mineral density). These participants will be divided into two groups. One group will take the drug risedronate orally once a week for 5 years while the other group takes an inactive compound. It will be recommended that these participants also take calcium and vitamin D supplements. Group 3 consists of participants diagnosed with osteoporosis (low bone mineral density). These participants will take risedronate orally once a week for 5 years. All women in this sub-study (Groups 1, 2 and 3) will be monitored with bone mineral density scans. Risedronate is a type of drug called a bisphosphonate which acts to increase bone mass and strength.
Interventions
The purpose of the bone sub-study is to examine the effect of anastrozole on Bone Mineral Density (BMD) and the risk of developing osteoporosis and fractures. Additionally it will explore the ability of bisphosphonate treatment to reduce the risk in women found to have low bone mineral density at baseline. BMD measurements in the lumbar spine and femoral neck will be performed in 1000 women from the initial entrants of the 6,000 women enrolled in the IBIS-II Prevention Trial (IBIS-II Prevention
The purpose of the bone sub-study is to examine the effect of anastrozole on Bone Mineral Density (BMD) and the risk of developing osteoporosis and fractures. Additionally it will explore the ability of bisphosphonate treatment to reduce the risk in women found to have low bone mineral density at baseline. BMD measurements in the lumbar spine and femoral neck will be performed in 1000 women from the initial entrants of the 6,000 women enrolled in the IBIS-II Prevention Trial (IBIS-II Prevention Protocol). The women will be divided into the following three strata: I. 300 women with T-scores (T) greater than or equal to minus one. These women will be monitored with dual energy X-ray absorptiometry (DXA) scans and recommended to take vitamin D and calcium supplements, but will not initially receive risedronate; II. 400 moderately to severely osteopenic women with T-scores between minus one and minus two point five will be randomised between risedronate sodium (Actonel, 35 mg, orally, once per week) or placebo (lactose pill, orally, once per week) and monitored by DXA scans. Vitamin D and calcium tablets will be recommended to all women; III. 300 Osteoporotic women with T-scores between minus two point five and minus four or up to two low trauma vertebral fractures will be required to take risedronate and be monitored by DXA scans. Risedronate is the bisphosphonate which will be used in the sub-study. The dose is 35 mg oral once a week and treatment will continue for 5 years.
Sponsors
Australia and New Zealand Breast Cancer Trials Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Outcome results
None listed