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Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00918749
First received: June 10, 2009
Last updated: March 25, 2011
Last verified: March 2011
History of Changes
  Purpose

Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.


Condition Intervention Phase
Postmenopausal Osteoporosis
 Drug: 150 mg
Drug: 75 mg
Drug: 100 mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Assessing the Efficacy, Safety, and Pharmacokinetics of 75 and 100 mg Once-a-month Delayed-release Risedronate Formulations Compared to 150 mg Once-a-month Immediate-release Risedronate for 3 Months in Postmenopausal Women Age 45-80

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.


Secondary Outcome Measures:
  • Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.

  • Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    ITT Population

  • Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    ITT Population

  • Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    ITT Population

  • Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    ITT Population

  • Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    ITT Population


Enrollment: 205
Study Start Date: May 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 150 mg
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
 Drug: 150 mg
150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
Experimental: 75 mg
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
 Drug: 75 mg
75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
Experimental: 100 mg
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
 Drug: 100 mg
100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female, 45 to 80 years of age, in good general health
  • postmenopausal ≥2 years, surgically or naturally
  • body mass index less than or equal to 32 kg/m^2 at screening

Exclusion Criteria:

  • no use within 3 months prior, nor use for more than 1 month at any time within 6 months of: glucocorticoids, anabolic steroids, estrogens, selective estrogen-receptor modulators (SERMs), or estrogen-related drugs, progestins, calcitonin, vitamin D supplements (>1200 IU per day), calcitriol, calcidiol, or alfacalcidol at any dose, any bisphosphonate. fluoride (≥10 mg/day), strontium (≥50 mg/day), parathyroid hormone, investigational bone active agents.
  • allergic or abnormal reactions to bisphosphonates
  • history of cancer within 5 years, excluding squamous and basal cell carcinoma with 6 month remission
  • positive pregnancy test
  • no depot injection >10,000 IU vitamin D in previous 9 months.
  • no history of GI disease that requires medication, or history of Crohn's disease, ulcerative colitis, diverticular disease, polyps, or surgery that could have changed GI structure or motility.
  • no history of frequent diarrhea or constipation that requires regular laxative use.
  • no history of alcohol or durg abuse, hyperparathyroidism, cancer previous 5 years, major surgery within 1 month prior to screening, diabetes, uncontrolled hypertension, cardiovascular, hepatic, renal or GI disease.
  • no active hyperthyroidism, osteomalacia, use of anticonvulsant medication, or allergic reaction to bisphosphonates
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918749

Locations
United States, Florida
Research Site
Daytona, Florida, United States, 32117
Research Site
Ft. Myers, Florida, United States, 33901
United States, Hawaii
Research Site
Honolulu, Hawaii, United States, 96821
United States, Indiana
Research Site
Evansville, Indiana, United States, 47711
United States, Texas
Research Site
Austin, Texas, United States, 78727
Research Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Chantell Wilson, PhD Procter and Gamble
  More Information

No publications provided

Responsible Party: Chantell L. Wilson, Ph.D./ Monitor, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00918749     History of Changes
Other Study ID Numbers: 2009003
Study First Received: June 10, 2009
Results First Received: February 23, 2011
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013