Clinical trial NCT00247273: A Study of Monthly Risedronate for Osteoporosis
Official title: A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: randomized controlled trial, osteoporosis, risedronate
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2005-11-01
Enrollment: 1294
Sex: FEMALE
Minimum age (years): 50
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 efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Detailed description: The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Eligibility criteria: Inclusion Criteria:

* Female: 50 years of age or older
* \>5 years since last menses natural or surgical
* have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
* BMI (body mass index) \>32 kg/m\^2
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
* markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
timeFrame: Baseline to Month 12 - Endpoint
Secondary outcomes:
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
timeFrame: Baseline to Month 12
measure: Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
timeFrame: Baseline to Month 12
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
timeFrame: Baseline to Month 24 - Endpoint
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
timeFrame: Baseline to Month 6
measure: Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in Serum CTX at Month 6, ITT Population
timeFrame: Baseline to Month 6
measure: Change From Baseline in Serum CTX at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in Serum CTX at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
timeFrame: Baseline to Month 6
measure: Percent Change From Baseline in Serum BAP at Month 6, ITT Population
timeFrame: Baseline to Month 6
measure: Change From Baseline in Serum BAP at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Percent Change From Baseline in Serum BAP at Month 24, ITT Population
timeFrame: Baseline to Month 24
measure: Number of Participants With New Vertebral Fracture at Month 12, ITT Population
timeFrame: Baseline to Month 12
measure: Number of Participants With New Vertebral Fracture at Month 24, ITT Population
timeFrame: Baseline to Month 24
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: West Haverstraw
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Buenos Aires
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Geelong
country: Australia
facility: Research Site
city: Heidelberg, Victoria
country: Australia
facility: Research Site
city: Saint Leonards
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Mont Godinne
country: Belgium
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
city: Sainte Foy
country: Canada
facility: Research Site
city: Saskatoon
country: Canada
facility: Research Site
city: Parnu
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Amiens Cedex 1
country: France
facility: Research Site
city: Lyon Cedex
country: France
facility: Research Site
city: Orleans
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Vandoeuvre Les Nancy
country: France
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nagykanizs
country: Hungary
facility: Research Site
city: Beirut
country: Lebanon
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Paradis
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: P&G
name: Sal Bartelmo, MD
role: STUDY_DIRECTOR
References: