Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density

Condition(s) targeted: Osteoporosis

Intervention: Placebo and raloxifene (Drug); zoledronic acid and placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Overall contact:
Novartis Pharmaceuticals, Phone: 862 778 8300

This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.

Official title: A Multi-Center, Randomized, Double-Blind, Double-Dummy Study in Postmenopausal Women With Low Bone Mineral Density to Compare the Effects of a Single Dose of i.v. Zoledronic Acid 5 mg, With Daily Oral Raloxifene 60 mg Once Daily on Bone Turnover Markers

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: change from baseline in urine N-telopeptide of Type 1 collagen (NTx) at 6 months

Secondary outcome:

change from baseline in urine NTx at 2 and 4 months and bone specific alkaline phosphatase (BSAP) at 2, 4 and 6 months

Overall physician, nurse and patient satisfaction with Satisfaction Questionnaire

Patient preference at 6 months for annual i.v therapy or daily oral regimens

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Females between the ages of 45 and 80

- Post-menopausal - ~no menses for 18 months if less than 50 years of age - ~no

menses for 12 months if more than 50 years of age

- DEXA scan T-score of less than or equal to -1. 5

Exclusion Criteria:

- Previous treatment with i. v. or oral bisphosphonates within the last 2 years

- Treatment with the following drugs within 6 months of study start: raloxifene,

calcitonin, tibolone or hormone replacement therapy

- Treatment with the following drugs: strontium renalate, sodium fluoride or parathyroid

hormone

Novartis Pharmaceuticals, Phone: 862 778 8300

Women's Health Research, Phoenix, Arizona 85015, United States; Recruiting
Phone: 602-249-3050

Associated Pharma Research Center, Buena Park, California 90620, United States; Recruiting
Phone: 914-952-2233

Washington, District of Columbia 20036, United States; Recruiting
Phone: 202-931-0000

Women's Physicians of Jacksonville, Jacksonville, Florida 32256, United States; Recruiting
Phone: 904-680-0871

Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States; Recruiting
Phone: 904-732-6674

Tampa Clinical Research, Tampa, Florida 33624, United States; Recruiting
Phone: 813-969-2824

Springfield Clinic, Springfield, Illinois 62703, United States; Recruiting
Phone: 217-528-7541

Consultants in Women's Health Care, St Louis, Missouri 63131, United States; Recruiting
Phone: 314-432-8181

Alegent Health, Omaha, Nebraska 68152, United States; Recruiting
Phone: 402-717-6945

Specialty Medical and Research Center, Pahrump, Nevada 89048, United States; Recruiting
Phone: 775-751-3005

UMDNJ-Robert Wood Johnson Medical Center, New Brunswick, New Jersey 08901, United States; Recruiting
Phone: 732-235-7292

Columbia University, New York, New York 10032, United States; Recruiting
Phone: 212-305-6146

Kernodle Clinic, Inc., Burlington, North Carolina 27215, United States; Recruiting
Phone: 336-524-9551

The Portland Clinic, Portland, Oregon 97205, United States; Recruiting
Phone: 503-221-0161

Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Phone: 503-494-3173

Texas Institute for Clinical Research, Fort Worth, Texas 76104, United States; Recruiting
Phone: 817-332-3135

Valley Women's Health Clinic, Renton, Washington 98055, United States; Recruiting
Phone: 425-228-0722

Starting date: January 2007
Ending date: November 2008
Last updated: January 23, 2008