STUDY PARTICIPATION
You are being asked to participate in this study because you are post-menopausal and have low bone mineral density. In addition, you must not have taken any drugs that have an effect on bone metabolism within the last 6 weeks. If you have questions about whether or not you have taken these kinds of drugs, you should ask your study doctor. If you have had bisphosphonates in the past, you have gone the minimum time without taking them to participate in the study (your doctor will ask you detailed questions about your past use of these drugs to determine your eligibility). Additionally, you do not have any conditions that might affect bone metabolism such as rheumatoid arthritis, Paget’s disease, or other diseases of this type.
If you agree to be in this study, you will be one of about 7200 people who will participate in this study at about 170 clinics in the United States, Europe, Canada, South America, Central America, Mexico, and Australia.
If it is determined that you are eligible to be in this trial, you will be randomly assigned (like flipping a coin) to receive one of two treatment options. You will receive either:
1. 60 mg AMG 162 subcutaneous (under the skin) injection one time every 6 months, or;
2. a placebo (non-active substance such as a salt solution) subcutaneous (under the skin) injection one time every 6 months
AMG 162 or placebo is given as one subcutaneous (under the skin) injection. You will also be provided with calcium and vitamin D supplements which you will take every day.
You will be randomized by chance to receive study drug or placebo. Your doctor will not be able to choose which treatment you will receive.
You will have a fifty:fifty chance of receiving study drug (AMG 162).