Clinical trial NCT00541658: A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 923
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 35 mg delayed release weekly 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 35 mg delayed release given weekly and 5 mg immediate release given daily.

Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
timeFrame: 52 weeks / Endpoint
Secondary outcomes:
measure: Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
timeFrame: Week 26
measure: Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
timeFrame: Week 52
measure: Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
timeFrame: Week 104
measure: Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
timeFrame: Week 104 / Endpoint
measure: Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population
timeFrame: Week 52
measure: Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population
timeFrame: Week 52
measure: Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population
timeFrame: Week 26
measure: Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population
timeFrame: Week 52
measure: Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population
timeFrame: Week 104
measure: Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population
timeFrame: Week 104 / Endpoint
measure: Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population
timeFrame: Week 26
measure: Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population
timeFrame: Week 52
measure: Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population
timeFrame: Week 104
measure: Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population
timeFrame: Week 104 / Endpoint
measure: Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population
timeFrame: Week 26
measure: Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population
timeFrame: Week 52
measure: Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population
timeFrame: Week 104
measure: Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint
timeFrame: Week 104 / Endpoint
measure: Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population
timeFrame: Week 13
measure: Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population
timeFrame: Week 26
measure: Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population
timeFrame: Week 52
measure: Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population
timeFrame: Week 104
measure: Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population
timeFrame: Week 104 / Endpoint
measure: Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population
timeFrame: Week 13
measure: Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population
timeFrame: Week 26
measure: Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population
timeFrame: Week 52
measure: Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population
timeFrame: Week 104
measure: Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population
timeFrame: Week 104 / Endpoint
measure: Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population
timeFrame: Week 13
measure: Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population
timeFrame: Week 26
measure: Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population
timeFrame: Week 52
measure: Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population
timeFrame: Week 104
measure: Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population
timeFrame: Week 104 / Endpoint
measure: Number of Patients With at Least One New Fractured Vertebra, Week 52
timeFrame: Week 52
measure: Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population
timeFrame: Week 52 / Endpoint
measure: Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population
timeFrame: Week 104
measure: Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population
timeFrame: Week 104 / Endpoint
measure: Number of Patients With No New Fractured Vertebra, Week 52
timeFrame: Week 52
measure: Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint
timeFrame: Week 52 / Endpoint
measure: Number of Patients With No New Fractured Vertebra, Week 104
timeFrame: Week 104
measure: Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
timeFrame: Week 104 / Endpoint
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Oakland
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Facility
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Leesburg
country: United States
facility: Research Site
state: Florida
city: Melbourne
country: United States
facility: Research Site
state: Florida
city: South Miami
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Champaign
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Brockton
country: United States
facility: Research Site
state: Massachusetts
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Research Site
city: Diepenbeek
country: Belgium
facility: Research Facility
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kitchener
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: St-Eustache
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Parnu
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Orleans
country: France
facility: Research Site
city: Vandoeuvre
country: France
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Koranyi Sandor
country: Hungary
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
Study officials:
affiliation: Procter and Gamble
name: Ana Balske, MD, PhD
role: STUDY_DIRECTOR
References:
citation: McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.