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

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ClinicalTrials.gov Identifier: NCT00918749
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : March 24, 2011
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Tracking Information
First Submitted Date  ICMJE June 10, 2009
First Posted Date  ICMJE June 11, 2009
Results First Submitted Date  ICMJE February 23, 2011
Results First Posted Date  ICMJE March 24, 2011
Last Update Posted Date June 29, 2015
Study Start Date  ICMJE May 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2011)
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 ]
Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
Serum CTX of subjects after 3 months of treatment dosed with risedronate 75 mg DR tablet administered immediately after breakfast compared to the risedronate 150 mg IR tablet administered per-label in postmenopausal women. [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT00918749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    ITT Population
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
  • CTX of the risedronate 100 mg DR tablet administered immediately after breakfast to the risedronate 150 mg IR tablet administered per-label [ Time Frame: 3 months ]
  • Serum BAP and urinary NTX of risedronate 150 mg IR tablet administered per-label compared with 75 mg DR tablet administered immediately after breakfast [ Time Frame: 3 months ]
  • Serum BAP and urinary NTX of risedronate 150 mg IR tablet administered per-label compared with 100 mg DR tablet administered immediately after breakfast [ Time Frame: 3 months ]
  • Safety and tolerability of the 75 and 100 mg DR tablets [ Time Frame: 3 months ]
  • Relative bioavailability based on Ae and A'e(% )of the 75 and 100 mg DR tablets administered immediately after breakfast compared to the 150 IR tablet administered per-label in a subset of subjects [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: 150 mg
    150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
  • Drug: 75 mg
    75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
  • Drug: 100 mg
    100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
Study Arms  ICMJE
  • Active Comparator: 150 mg
    150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
    Intervention: Drug: 150 mg
  • Experimental: 75 mg
    75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
    Intervention: Drug: 75 mg
  • Experimental: 100 mg
    100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
    Intervention: Drug: 100 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2011)
205
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2009)
201
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00918749
Other Study ID Numbers  ICMJE 2009003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warner Chilcott
Study Sponsor  ICMJE Warner Chilcott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chantell Wilson, PhD Procter and Gamble
PRS Account Warner Chilcott
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP