DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Population

Percent 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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017