A 3 year, double-blind extension to CZOL446H2301 to evaluate the long term safety and efficacy of zoledronic acid in the treatment of osteoporosis in postmenopausal women taking calcium and vitamin D. - 2301 E1

INTERVENTION: Trade Name: Aclasta Product Name: Aclasta Product Code: ZOL446H Pharmaceutical Form: Solution for infusion INN or Proposed INN: zoledronic acid Current Sponsor code: ZOL446H Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Osteoporosis in postmenopausal women ; MedDRA version: 9.1 Level: LLT Classification code 10031282 Term: Osteoporosis PRIMARY OUTCOME: Main Objective: To assess the percent change in BMD of the femoral neck as measured by DXA at Year 6 relative to Year 3 in patients treated with zoledronic acid for up to 6 years in the CZOL446H2301 core and extension studies (Group Z6) compared to patients treated with zoledronic acid for 3 years in the CZOL446H2301 core study followed by up to 3 years of placebo in the CZOL446H2301 extension study (Group Z3P3). Primary end point(s): Percent change in BMD of the femoral neck at Year 6 relative to Year 3 in Z6 patients compared to Z3P3 patients.; ; Secondary Objective: •To assess the percent changes in BMD of the femoral neck, total hip, and trochanter at Year 4.5 and Year 6 relative to Year 0 in Z6 patients compared to Z3P3 patients.; ; •To assess the percent changes in BMD of the femoral neck, total hip, and trochanter at Year 4.5 relative to Year 3 in Z6 patients compared to Z3P3 patients.; ; •To assess the percent changes in BMD of the total hip and trochanter at Year 6 relative to Year 3 in Z6 patients compared to Z3P3 patients.; ; •To assess the relative change in biochemical markers of bone turnover at Year 4.5 and Year 6 relative to Year 0 and Year 3 in Z6 patients compared to Z3P3 patients.; ; •To assess the relative change in biochemical markers of bone turnover at Year 3.5, 4, 4.5, 5, and 6 relative to Year 0 and Year 3 in a subset of approximately 200 Z6 and Z3P3 patients who participated in this subset in the core study.; INCLUSION CRITERIA: •Women, 93 years of age and under, inclusive (at the time of randomization in extension study) who have received 3 infusions of study medication in the core study according to the guidelines and instructions provided. •Signed written informed consent to participate in the extension study •Patients must be considered ambulatory. Patients can be included who are ambulatory with an assistive device (cane, walker, etc) •Patients must have been taking the dosage of calcium and vitamin D required in the core study (1000 to 1500 mg of elemental calcium and 400 to 1200 IU of vitamin D daily) for at least 3 months prior to entry into the extension and have a serum calcium within the normal range at baseline •Patients must have DXA measurements of the hip performed at Visit 7 (final core study visit) • Patients must be randomized into the extension study at Visit 8 between 10 and 18 months after receiving their third dose of study medi