A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

Warner Chilcott923 enrolled

Overview

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.

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

923

Conditions

Postmenopausal Osteoporosis

Interventions

risedronateDRUG

5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily

risedronateDRUG

35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly

risedronateDRUG

35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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 (45)

Outcomes

Primary Outcomes

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population

Time frame: 52 weeks / Endpoint

Secondary Outcomes

Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population

Time frame: Week 52 / Endpoint

Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population

Time frame: Week 26

Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population

Time frame: Week 52

Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population

Time frame: Week 104

Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population

Time frame: Week 104 / Endpoint

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population

Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

Time frame: Week 52

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population

Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

Time frame: Week 52 / Endpoint

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population

Data from ClinicalTrials.gov

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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

...and 35 more locations

Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population

Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

Time frame: Week 52 / Endpoint

Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population

Time frame: Week 26

Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population

Time frame: Week 52

Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population

Time frame: Week 52 / Endpoint

Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population

Time frame: Week 104

Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population

Time frame: Week 104 / Endpoint

Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population

Time frame: Week 26

Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population

Time frame: Week 52

Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population

Time frame: Week 52 / Endpoint

Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population

Time frame: Week 104

Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population

Time frame: Week 104 / Endpoint

Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population

Time frame: Week 26

Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population

Time frame: Week 52

Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint

Time frame: Week 52 / Endpoint

Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population

Time frame: Week 104

Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint

Time frame: Week 104 / Endpoint

Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population

Time frame: Week 13

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population

Time frame: Week 26

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population

Time frame: Week 52

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population

Time frame: Week 52 / Endpoint

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population

Time frame: Week 104

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population

Time frame: Week 104 / Endpoint

Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population

Time frame: Week 13

Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population

Time frame: Week 26

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population

Time frame: Week 52

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population

Time frame: Week 52 / Endpoint

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population

Time frame: Week 104

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population

Time frame: Week 104 / Endpoint

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population

Time frame: Week 13

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population

Time frame: Week 26

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population

Time frame: Week 52

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population

Time frame: Week 52 / Endpoint

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population

Time frame: Week 104

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population

Time frame: Week 104 / Endpoint

Number of Patients With at Least One New Fractured Vertebra, Week 52

Time frame: Week 52

Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population

Time frame: Week 52 / Endpoint

Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population

Time frame: Week 104

Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population

Time frame: Week 104 / Endpoint

Number of Patients With No New Fractured Vertebra, Week 52

Time frame: Week 52

Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint

Time frame: Week 52 / Endpoint

Number of Patients With No New Fractured Vertebra, Week 104

Time frame: Week 104

Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint

Time frame: Week 104 / Endpoint