A 3-year, multicenter, double-blind, randomized, placebo-controlled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - 2301 E2

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 500

Inclusion Criteria

1. Women who have completed Study CZOL446H2301E1 and received at least the 4th and 6th doses of zoledronic in Study CZOL446H2301E1according to the guidelines and instructions provided.

2. Signed written informed consent to participate in the Study CZOL446H2301E2.

3. Patients must be considered ambulatory. Patients can be included who are ambulatory with an assistive device (cane, walker, etc).

4. Patients must have been taking the dosage of calcium and vitamin D required in CZOL446H2301E1(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 CZOL446H2301E2.

5. Patients must have DXA measurements of the hip performed at Visit 11 (Study CZOL446H2301E1 final study visit).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who demonstrated a major protocol violation in Study CZOL446H2301E1 or patients for whom the investigator feels participation in Study CZOL446H2301E2 is not appropriate.

2. Any prior use of iv bisphosphonate other than the study drug during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2.

3. Any use of oral bisphosphonates for more than 1 month total during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2.

4. Any prior use of PTH for more than 1 month during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2.

5. Use of systemic corticosteroids (oral or i.v.) at an average dose of greater than or equal to 7.5 mg per day of oral prednisone or equivalent for a period of three months just prior to randomization into Study CZOL446H2301E2. Note: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articularly) are NOT exclusionary.

6. Any use of anabolic steroids or growth hormone for more than 3 months just prior to randomization into Study CZOL446H2301E2.

7. Any prior use of strontium (all formulations).

8. Any use of sodium fluoride for osteoporosis during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2.

9. Serum calcium less than 8 mg/dL (2.0 mmol/L) at Visit 11 in Study CZOL446H2301E1 or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2.

10. Serum calcium greater than 11.0 mg/dL (2.75 mmol/L) at Visit 11 in Study CZOL446H2301E1 or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2.

11. Active primary hyperparathyroidism.

12. Surgery to the thyroid or parathyroids resulting in partial or complete hypoparathyroidism.

13. Uncontrolled seizure disorders associated with falls.

14. Bilateral hip replacement or bilateral hip surgery with implantation of an appliance during the Study CZOL446H2301E1.

15. Patients with a new diagnosis or active treatment for cancer with the exception of treated non-melanoma skin cancer during the course of Study CZOL446H2301E1.

16. Multiple myeloma or Paget’s disease diagnosed or discovered during Study CZOL446H2301E1.

17. Active iritis or uveitis at the time of randomization.

18. History of diabetic nephropathy or retinopathy or uncontrolled diabetes (e.g. patients with a history of HbA1c > 10%).

19. A calculated creatinine clearance less than 30.0 mL/min (0.5 mL/sec) or urine dipstick greater than 2+ protein without evidence of contamination or bacteriuria at Visit 11 (final Study CZOL446H2301E1 study visit) or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2.

20. History of hypersensitivity to bisphosphonates or any serious adverse reaction to the study drug during Study CZOL446H2301E1.

21. Use of other investigational drugs within 3 months prior to randomization in Study CZOL446H2301E2.

22. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the Protocol or completing the trial per protocol.

23. Patients with a decrease in bone mineral density at the total hip of greater than 10% from basel

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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