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

NCT00431444 | Completed Phase 4 Results

• 1 other identifier: CZOL446HUS121
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 17

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

Keywords

Osteoporosis; Post-menopausal; Bone mineral density

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)

  The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

  Baseline and 6 months

Secondary Outcomes (9)

• Change From Baseline in Urine NTx at 2 Months

  Baseline and 2 months

• Change From Baseline in Urine NTx at 4 Months

  Baseline and 4 months

• Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months

  Baseline and 2 months

• Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months

  Baseline and 4 months

• Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months

  Baseline and 6 months

Study Arms (2)

Zoledronic Acid

ACTIVE COMPARATOR

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

Drug: Zoledronic acid; Drug: Placebo oral pills

Raloxifene

ACTIVE COMPARATOR

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

Drug: Raloxifene; Drug: Placebo intravenous (i.v.) infusion

Interventions

Raloxifene DRUG

Raloxifene

Zoledronic acid DRUG

Also known as: Reclast, Aclasta

Zoledronic Acid

Placebo oral pills DRUG

Zoledronic Acid

Placebo intravenous (i.v.) infusion DRUG

Raloxifene

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (17)

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Associated Pharma Research Center

Buena Park, California, 90620, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20036, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Women's Physicians of Jacksonville

Jacksonville, Florida, 32256, United States

Location

Tampa Clinical Research

Tampa, Florida, 33624, United States

Location

Springfield Clinic

Springfield, Illinois, 62703, United States

Location

Consultants in Women's Health Care

St Louis, Missouri, 63131, United States

Location

Alegent Health

Omaha, Nebraska, 68152, United States

Location

Specialty Medical and Research Center

Pahrump, Nevada, 89048, United States

Location

UMDNJ-Robert Wood Johnson Medical Center

New Brunswick, New Jersey, 08901, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Kernodle Clinic, Inc.

Burlington, North Carolina, 27215, United States

Location

The Portland Clinic

Portland, Oregon, 97205, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Texas Institute for Clinical Research

Fort Worth, Texas, 76104, United States

Location

Valley Women's Health Clinic

Renton, Washington, 98055, United States

Location

Related Publications (1)

• 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.

  PMID: 21796066 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Raloxifene Hydrochloride; Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 5, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 29, 2011
• Results First Posted: March 11, 2011

Record last verified: 2011-03

Locations

US (17)