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

Postmenopausal Osteoporosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541658
• Other study ID #: 2007008
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2007
• Last updated: April 15, 2013
• Start date: October 2007
• Est. completion date: April 2010

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 923
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• risedronate
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
• risedronate
35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
• risedronate
35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Belgium	Research Facility	Diepenbeek
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	St-Eustache	Quebec
Estonia	Research Site	Parnu
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
France	Research Site	Amiens
France	Research Site	Lyon
France	Research Site	Orleans
France	Research Site	Vandoeuvre
Hungary	Research Site	Balatonfured
Hungary	Research Site	Debrecen
Hungary	Research Site	Eger
Hungary	Research Site	Gyor
Hungary	Research Site	Koranyi Sandor
Poland	Research Site	Bialystok
Poland	Research Site	Warszawa
United States	Research Site	Bethesda	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Brockton	Massachusetts
United States	Research Site	Champaign	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Gainesville	Georgia
United States	Research Site	Greenville	North Carolina
United States	Research Site	Lakewood	Colorado
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Leesburg	Florida
United States	Research Site	Madison	Wisconsin
United States	Research Site	Melbourne	Florida
United States	Research Site	Oakland	California
United States	Research Site	Omaha	Nebraska
United States	Research Site	Portland	Oregon
United States	Research Site	San Diego	California
United States	Research Site	Seattle	Washington
United States	Research Site	South Miami	Florida
United States	Research Facility	Walnut Creek	California
United States	Research Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Estonia,  France,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population		52 weeks / Endpoint	Yes
Secondary	Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population		Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population		Week 26	Yes
Secondary	Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population		Week 52	Yes
Secondary	Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population		Week 104	Yes
Secondary	Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population		Week 104 / Endpoint	Yes
Secondary	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.	Week 52	Yes
Secondary	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.	Week 52 / Endpoint	Yes
Secondary	Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population	Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.	Week 52	Yes
Secondary	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.	Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population		Week 26	Yes
Secondary	Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population		Week 52	Yes
Secondary	Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population		Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population		Week 104	Yes
Secondary	Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population		Week 104 / Endpoint	Yes
Secondary	Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population		Week 26	Yes
Secondary	Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population		Week 52	Yes
Secondary	Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population		Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population		Week 104	Yes
Secondary	Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population		Week 104 / Endpoint	Yes
Secondary	Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population		Week 26	Yes
Secondary	Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population		Week 52	Yes
Secondary	Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint		Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population		Week 104	Yes
Secondary	Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint		Week 104 / Endpoint	Yes
Secondary	Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population		Week 13	Yes
Secondary	Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population		Week 26	Yes
Secondary	Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population		Week 52	Yes
Secondary	Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population		Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population		Week 104	Yes
Secondary	Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population		Week 104 / Endpoint	Yes
Secondary	Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population		Week 13	Yes
Secondary	Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population		Week 26	Yes
Secondary	Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population		Week 52	Yes
Secondary	Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population		Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population		Week 104	Yes
Secondary	Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population		Week 104 / Endpoint	Yes
Secondary	Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population		Week 13	Yes
Secondary	Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population		Week 26	Yes
Secondary	Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population		Week 52	Yes
Secondary	Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population		Week 52 / Endpoint	Yes
Secondary	Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population		Week 104	Yes
Secondary	Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population		Week 104 / Endpoint	Yes
Secondary	Number of Patients With at Least One New Fractured Vertebra, Week 52		Week 52	Yes
Secondary	Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population		Week 52 / Endpoint	Yes
Secondary	Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population		Week 104	Yes
Secondary	Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population		Week 104 / Endpoint	Yes
Secondary	Number of Patients With No New Fractured Vertebra, Week 52		Week 52	Yes
Secondary	Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint		Week 52 / Endpoint	Yes
Secondary	Number of Patients With No New Fractured Vertebra, Week 104		Week 104	Yes
Secondary	Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint		Week 104 / Endpoint	Yes