Clinical trial NCT00100555: A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
Official title: A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Osteoporosis, osteopenia, post-menopausal, zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women between 45 and 79 years of age
* Must be osteopenic/osteoporotic

Exclusion Criteria:

* Any women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women
Secondary outcomes:
measure: To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women
measure: To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist
measure: To assess patient preferences for annual i.v. therapy compared to weekly oral therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ. of Alabama/Division of Clinical Immunology and Rheumatology
state: Alabama
city: San DIego
country: United States
facility: Radiant Research
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern Center for Clinical Research
state: Illinois
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Kalamazoo
country: United States
facility: Midwest Arthritis Center
state: Michigan
city: Springfield
country: United States
facility: St. John's Medical Research
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic Research Division
state: Montana
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson Medical School
state: New Jersey
city: West Haverstraw
country: United States
facility: Helen Hayes Hospital - Regional Bone Clinic
state: New York
city: Mayfield Village
country: United States
facility: Private Practice
state: Ohio
city: Jackson
country: United States
facility: The Arthritis Clinic of Jackson
state: Tennessee
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Fort Worth
country: United States
facility: Univ. of North Texas Health Science Center at Fort Worth
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education
state: Texas
city: Salt Lake City
country: United States
facility: Women's Health Center
state: Utah
city: Lewisburg
country: United States
facility: Valley Medical Associates
state: West Virginia
Study officials:
References: