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

NCT ID: NCT00431444

Last Updated: 2011-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-07-31

Brief Summary

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zoledronic Acid

Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group)

Group Type: ACTIVE_COMPARATOR

Zoledronic acid

Intervention Type: DRUG

Placebo oral pills

Intervention Type: DRUG

Raloxifene

Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)

Group Type: ACTIVE_COMPARATOR

Raloxifene

Intervention Type: DRUG

Placebo intravenous (i.v.) infusion

Intervention Type: DRUG

Interventions

Raloxifene

Intervention Type: DRUG

Zoledronic acid

Intervention Type: DRUG

Placebo oral pills

Intervention Type: DRUG

Placebo intravenous (i.v.) infusion

Intervention Type: DRUG

Other Intervention Names

Reclast, Aclasta

Eligibility Criteria

Inclusion Criteria

• Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:
• Cessation of menses for 18 months in women < 50 years of age
• Cessation of menses for 12 months in women age 50 years or over
• Documented bilateral oophorectomy at least 1 year previously
• Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis
• Signed informed consent prior to initiation of any study procedure

Exclusion Criteria

• Prior treatment with i.v. bisphosphonates within the last 2 years
• Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*).
• *NOTE: If used less than 8 weeks, the washout period is 6 months.
• Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
• Any treatment with strontium renalate, sodium fluoride or parathyroid hormone
• Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year
• Treatment with any investigational drug within 30 days prior to randomization
• Any woman of child bearing potential
• Patients with fractures occurring within three months prior to randomization
• History of hypersensitivity to bisphosphonates
• History of non-traumatic uveitis or iritis, within 2 years prior to study entry.
• A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
• Previous major solid organ transplant recipient or on a transplant waiting list
• History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
• Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months
• Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial
• Active dental infection, unhealed dental extraction or planned oral surgery within 3 month prior to randomization.
• Calculated creatinine clearance < 30 mL/min
• Greater than 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
• Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.08 mmol/L (8.3 mg/dL) at screening
• AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Women's Health Research

Phoenix, Arizona, United States

Associated Pharma Research Center

Buena Park, California, United States

Washington D.C., District of Columbia, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Women's Physicians of Jacksonville

Jacksonville, Florida, United States

Tampa Clinical Research

Tampa, Florida, United States

Springfield Clinic

Springfield, Illinois, United States

Consultants in Women's Health Care

St Louis, Missouri, United States

Alegent Health

Omaha, Nebraska, United States

Specialty Medical and Research Center

Pahrump, Nevada, United States

UMDNJ-Robert Wood Johnson Medical Center

New Brunswick, New Jersey, United States

Columbia University

New York, New York, United States

Kernodle Clinic, Inc.

Burlington, North Carolina, United States

The Portland Clinic

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Texas Institute for Clinical Research

Fort Worth, Texas, United States

Valley Women's Health Clinic

Renton, Washington, United States

Countries

United States

References

Bachmann G, Kriegman A, Goncalves J, Kianifard F, Warren M, Simon JA. Effect of zoledronic acid compared with raloxifene on bone turnover markers in postmenopausal women with low bone density. Menopause. 2011 Aug;18(8):851-6. doi: 10.1097/gme.0b013e31820b80f1.

Reference Type: DERIVED

PMID: 21796066 (View on PubMed)

Other Identifiers

CZOL446HUS121

Identifier Type: -

Identifier Source: org_study_id