A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: risedronate (Drug); risedronate (Drug); risedronate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Warner Chilcott Official(s) and/or principal investigator(s): Ana Balske, MD, PhD, Study Director, Affiliation: Procter and Gamble
Summary
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing
regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Clinical Details
Official title: A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
Secondary outcome: Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT PopulationPercent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population Number of Patients With at Least One New Fractured Vertebra, Week 52 Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population Number of Patients With No New Fractured Vertebra, Week 52 Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint Number of Patients With No New Fractured Vertebra, Week 104 Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
Detailed description:
The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5
mg immediate release given daily.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female: 50 years of age or older
- >5 years since last menses natural or surgical
- have lumbar spine or total hip BMD more that 2. 5 SD below the young adult mean, or
have lumbar spine or total hip 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 >32 kg/m
- 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
Locations and Contacts
Research Site, Buenos Aires, Argentina
Research Facility, Diepenbeek, Belgium
Research Site, Gent, Belgium
Research Site, Leuven, Belgium
Research Site, Quebec, Canada
Research Site, Parnu, Estonia
Research Site, Tallinn, Estonia
Research Site, Tartu, Estonia
Research Site, Amiens, France
Research Site, Lyon, France
Research Site, Orleans, France
Research Site, Vandoeuvre, France
Research Site, Balatonfured, Hungary
Research Site, Debrecen, Hungary
Research Site, Eger, Hungary
Research Site, Gyor, Hungary
Research Site, Koranyi Sandor, Hungary
Research Site, Bialystok, Poland
Research Site, Warszawa, Poland
Research Site, Birmingham, Alabama, United States
Research Site, Oakland, California, United States
Research Site, San Diego, California, United States
Research Facility, Walnut Creek, California, United States
Research Site, Walnut Creek, California, United States
Research Site, Lakewood, Colorado, United States
Research Site, Leesburg, Florida, United States
Research Site, Melbourne, Florida, United States
Research Site, South Miami, Florida, United States
Research Site, Gainesville, Georgia, United States
Research Site, Champaign, Illinois, United States
Research Site, Chicago, Illinois, United States
Research Site, Bethesda, Maryland, United States
Research Site, Brockton, Massachusetts, United States
Research Site, Omaha, Nebraska, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Greenville, North Carolina, United States
Research Site, Hamilton, Ontario, Canada
Research Site, Kitchener, Ontario, Canada
Research Site, Newmarket, Ontario, Canada
Research Site, Portland, Oregon, United States
Research Site, Montreal, Quebec, Canada
Research Site, St-Eustache, Quebec, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Seattle, Washington, United States
Research Site, Madison, Wisconsin, United States
Additional Information
Starting date: October 2007
Last updated: April 15, 2013
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