An Observational Follow-up study for: A Phase III Randomized Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fractures in Osteoporotic Postmenopausal Women Treated with Vitamin D and Calcium (protocol 018)
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- STATUS
- Not Recruiting
Summary
The objective of this study is to collect and assess safety information for the double-blinded treatment period ending 5 years post-randomization regarding deaths, SAEs, adverse events requiring adjudication, and skin Events of Clinical Interests in subjects who were randomized and took at least one dose of blinded study medication, then discontinued from study drug but have not completed follow - up through the 5-year blinded treatment period of Protocol 018 and its 1st extension. These data will be analyzed together with data from subjects who have completed 5 years of blinded study medication.
Description
The objective of this study is to collect and assess safety information for the double-blinded treatment period ending 5 years post-randomization regarding deaths, SAEs, adverse events requiring adjudication, and skin Events of Clinical Interests in subjects who were randomized and took at least one dose of blinded study medication, then discontinued from study drug but have not completed follow - up through the 5-year blinded treatment period of Protocol 018 and its 1st extension. These data will be analyzed together with data from subjects who have completed 5 years of blinded study medication.
Details
| Condition | osteoporosis |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX6915 |
| Last Modified on | 19 February 2024 |
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